Method For Improved Accuracy Of Blood Testing

Abstract

This disclosed method improves the accuracy of testing blood for the levels of contaminant, such as lead, cadmium and mercury, in individuals. The method comprises cleaning the area where the skin will be penetrated to obtain the blood sample to remove the contaminant to be measured in the blood. The cleansing is accomplished with a cleanser formulated to remove the contaminant to be measured in the blood from the surface of the skin, the pores, sweat ducts, hair follicles and sebaceous gland ducts. The method reduces contamination of the blood sample by contaminants on, and/or in the portion of the skin through which the blood sample is drawn. A premoistened wipe can also be used that mobilizes heavy metals from the skin surface, the skin pores, sweat ducts, hair follicles and sebaceous gland ducts, and is formed with a wipe substrate material selected for its affinity to bind the toxic materials.

Claims

1. A method for performing a blood contaminant test, the method comprising the steps of: a) cleaning a blood sampling site on an individual prior to collection of a blood sample by: i) applying a metal contaminant-removing cleanser to a blood sampling site to remove the metal contaminant to be measured in the blood from the surface of the skin, and from subsurface areas of the site, including the pores, sweat ducts, hair follicles and sebaceous glands at the site, the cleanser comprising at least one surfactant, an anti-static component and at least one metal contaminant-removing agent present in an amount of between 0.1% w/w to about 25% w/w of the cleanser; ii) dissipating a static charge on the metal contaminant holding the metal contaminant on the skin surface and subsurface areas; and iii) removing the skin cleanser along with the metal contaminant from the site while drying the site using a fabric substrate, wherein the fabric substrate in conjunction with the cleanser binds the contaminant to the fabric; b) obtaining a venous blood sample at the cleaned sampling site; and c) performing an analysis on the blood sample obtained from the site to determine the amount of the contaminant in the blood sample, wherein the accuracy of the sampling and analysis of the blood sample for elevated levels of the contaminant in the blood sample is +/−3ug/100 mL.

2. The method of claim 1 wherein the at least one contaminant-removing agent is a chelating agent.

3. The method of claim 1 wherein the at least one contaminant-removing agent is a phosphonate.

4. The method of claim 1 wherein the at least one contaminant-removing agent is a combination of a chelating agent and a phosphonate.

5. The method of claim 1 wherein the at least one surfactant is selected from the group consisting of at least one cationic surfactant, at least one anionic surfactant, at least one amphoteric surfactant and combinations thereof.

6. The method of claim 1 wherein the at least one contaminant-removing agent is a terpene.

7. The method of claim 1 wherein the at least one contaminant-removing agent is a combination of a terpene and a phosphonate.

8. The method of claim 1 wherein the cleanser comprises two or more of: a) a terpene; b) a surfactant; c) an alkanolamine; d) an amine oxide; and e) a phosphonate.

9. The method of claim 1 further comprising the step of scrubbing the site with a contaminant-removing substrate moistened with a contaminant-removing solution after removing the cleanser.

10. The method of claim 9 wherein the step of scrubbing the site with the substrate comprises simultaneously exfoliating dead cells on the site.

11. The method of claim 1 wherein the cleanser further comprises an abrasive and further comprising the step of exfoliating dead cells from the site simultaneously with applying the cleanser to the site.

12. The method of claim 1 wherein the step of applying the skin cleanser comprises: a) applying water to the site; and b) applying the skin cleanser to the site.

13. The method of claim 12 further comprising the steps of: a) rinsing the site with water after applying the cleanser to the site; and b) scrubbing the site with a contaminant-removing substrate moistened with a contaminant-removing solution after rinsing the site.

14. The method of claim 13 further comprising the steps of: a) reapplying the cleanser to the site after rinsing the site and before scrubbing the site; and b) re-rinsing the site with water prior to scrubbing the site.

15. The method of claim 1 wherein the step of applying the cleanser to the site does not include water.

16. The method of claim 15 wherein the step of removing the cleanser from the site does not include water.

17. The method of claim 1 further comprising the step of disinfecting the site after removing the cleanser from the site.

18. The method of claim 1 wherein the contaminant to be removed is an inorganic metal.

19. The method of claim 18 wherein the inorganic metals is selected from the group consisting of calcium, magnesium, lead, mercury, cadmium, manganese, strontium, barium, iron, cobalt, nickel, copper, zinc, thorium, radium and uranium.

20. A method for improving the blood flow at a blood sampling site, the method comprising the steps of: a) applying a contaminant-removing cleanser to the site to remove the contaminant to be measured in the blood from the surface of the skin, the pores, sweat ducts, hair follicles and sebaceous glands at the site, the cleanser comprising at least one surfactant, an anti-static component, at least one metal contaminant-removing agent present in an amount of between 0.1% w/w to about 25% w/w of the cleanser and at least one calcium-removing agent present in an amount of between 0.1% w/w to about 25% w/w of the cleanser, and b) removing the skin cleanser from the site.

21. The method of claim 20 wherein the method does not include water.

22. A method for performing a blood contaminant test, the method comprising the steps of: a) cleaning a blood sampling site on an individual prior to collection of a blood sample by: i) applying a metal contaminant-removing cleanser to a blood sampling site to remove the metal contaminant to be measured in the blood from the surface of the skin, and from subsurface areas of the site, including the pores, sweat ducts, hair follicles and sebaceous glands at the site, the cleanser comprising at least one surfactant, an anti-static component and at least one metal contaminant-removing agent present in an amount of between 0.1% w/w to about 25% w/w of the cleanser, ii) dissipating a static charge on the metal contaminant holding the metal contaminant on the skin surface and subsurface areas; and iii) removing the skin cleanser along with the metal contaminant from the site while drying the site using a fabric substrate, wherein the fabric substrate in conjunction with the cleanser binds the contaminant to the fabric; b) obtaining a venous blood sample at the cleaned sampling site; and c) performing an analysis on the blood sample obtained from the site to determine the amount of the contaminant in the blood sample, wherein the accuracy of the sampling and analysis of the blood sample for elevated levels of the contaminant in the blood sample is +/−7.5%.

23. The method of claim 22 wherein the at least one surfactant, an anti-static component and at least one metal contaminant-removing agent are different from one another.

24. The method of claim 1 wherein the at least one surfactant, an anti-static component and at least one metal contaminant-removing agent are different from one another.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0173] In the drawing figures:

[0174] FIG. 1 is a cross-sectional view of the layers in the skin on an individual; and

[0175] FIG. 2 is a schematic view of a venipuncture being performed through the skin surface of an individual.

DETAILED DESCRIPTION OF THE INVENTION

[0176] The present invention is a method for the use of certain skin cleaning preparations that are highly effective in the removal of both surface and subsurface contaminants on the skin of an individual in order to enable a blood sample to be obtained from the individual with little or no contamination from contaminants on or in the section of skin through which the blood sample is obtained. The skin cleaning preparations usable in the method are formed at least with: a) a surfactant or a soap; and b) a chelating agent, among other suitable components.

I. Skin Cleaner Components

[0177] A. Surfactants

[0178] Surface active agents or surfactants and ordinary soaps are used in cleaning formulations for their ability to: lower the surface tension of the water, wet contaminants and break the adhesive forces.

[0179] Some examples of ingredients that when combined in the proper amounts will perform these functions in an efficient manner to best clean and prepare a blood sample stick site include, by way of example:

[0180] Surfactants that are efficient providing the properties of good wetting agents for metals, metal oxides and metal salts, and do not form precipitates with the metals commonly tested in blood, include the arylalkyl sulfonates for example the sodium linear alkyl sulfonates. These are classified as anionic surfactants. Sodium dodecylbenzene sulfonate is a particularly good example of an efficient wetting agent with a very good ability to lower the surface tension of water and does not form metallic precipitates. They are particularly good in the formulation of the cleaning compounds described here due these abilities as well as their ability to increase the solubility of other surfactants in the presence of metals, metal oxides and metal salts. Another efficient class of surfactants beneficial to meeting these objectives is the alkyl sulfates of which sodium laureth sulfate and sodium lauryl sulfate are representative members and the alkyl ether sulfates, of which sodium lauryl ether sulfate is a representative member.

[0181] Surfactants that are efficient providing antistatic properties include all of the quaternary surfactants. Quaternaries contain at least one nitrogen atom linked covalently to four aryl or alkyl groups. This results in the formation of a positively charged nitrogen atom which is retained regardless of the pH. The types of compounds that provide this form of antistatic property include the Alkylbenzyldimethylammonium salts, such as Benzalkonium chloride, Benzethonium chloride, Steralkonium chloride and Quaternium-63; the betaines, such as the alkyl betaines, alkylamidopropyl betaines and alkylimidopropyl betaines; the heterocyclic ammonium salts, such as Alkylethyl morpholinium ethosulfate and Cetylpyridinium chloride; the tetraalkylammonium salts, the hydroxyalkyl trialkylammonium salts and tetraalkylammonium salts. All of these listed quaternary compounds are cationic surfactants. Another class of antistatic surfactants includes the phosphoric acid esters and salts, for example the anionic surfactant Lecithin and the mono- and d-phosphates which are zwitterionic surfactants. Another potential benefit derived from incorporating quaternary ammonium compounds, such as benzalkonium chloride is its demonstrated antibacterial ability and functionality.

[0182] Another surfactant type with excellent antistatic properties is of the non-ionic type known as Amine oxides. The amine oxides in addition to providing additional antistatic performance also are effective at dispersing calcium oxides, magnesium oxides and the other metal oxides with the tendency (like calcium and lead) to produce precipitates with other surfactants and at reducing the skin irritating characteristics of the surfactants listed above that may be used in formulations of this type. Examples of Amine oxides that can provide these functions include Oleyl dimethylamine oxide, Cocamidopropyl dimethylamine oxide, Lauramine oxide, Cocamidopropylamine oxide and Lauryl dimethylamine oxide.

[0183] The combination of one or more members of the types of cationic surfactants combined with one or members of the anionic and/or zwitterionic quaternary compounds and/or one or more members of the non-ionic amine oxides provides excellent wetting, lowered surface tension and ability to reduce the static and other adhesive forces that bind metals, metal oxides and metal salts to the skin. When these ingredients are combined with an amine oxide the resulting base skin cleaner formulation is mild to the skin and contains cationic, anionic and non-ionic surfactants in a stable blend with excellent wetting, surface activity, adhesion and antistatic reduction for a wide range of metals and metal compounds as well as good cleaning ability for the broad spectrum of possible or likely skin contaminants.

[0184] B. Chelating Agents

[0185] 1. EDTA

[0186] In order to maximize the efficiency of this combination of surfactants, any water hardness present must be controlled. Traditionally this is accomplished by adding a small level of chelating agent Compounds which are commonly used and effective in performing the functions of chelating and sequestering the water hardness metals as well as the other metals of interest in blood samples include by way of example Tetrasodium EDTA and Disodium EDTA, citric acid and sodium citrate as well as the other chelates listed below. Chemical sequesterants, such as the phosphonates which are not often used in skin cleaner formulations also perform this function very well, and in the current instance of concern with maximum removal of the heavy metal, toxic metal, beneficial trace metal and transition metal contaminants actually perform better than the traditional chelating agents due to some of their other unique properties.

[0187] Liquid skin cleaners used in the present invention include an elevated level of a chelating agent, such as EDTA or a citrate, and/or an elevated level of sequesterants, such as a phosphonate, in order to perform the function of metal removal from the skin to a better extent than prior art soap or skin cleansers that have 0.05% to 0.25% by weight levels of EDTA. These levels are typically just enough to control water hardness, improve lather, stability and shelf life. Since they are typically completely consumed by the water hardness, there is little or none left to deal with the other metals present. Many of the metals of concern act like water hardness in soap-detergent systems. Chelates, such as EDTA, or the tetra sodium or disodium salts thereof are all effective to a degree. They are available from Dow Chemical Co., for example, under the trademark Versene®. EDTA is a common ingredient of hair shampoos and some skin cleansers. It is added typically to help soften the water by chelating calcium and magnesium atoms. Other chelating agents, including by way of example, NTA, HEEDTA, DTPA, DEG and EDG, but certainly including other chelating agents, can be expected to also provide enhanced metal removal from the skin. However, the level required to accomplish lead removal in the method of the present invention is significantly higher than the typical level found in these common skin cleaners.

[0188] However, while EDTA and similar chelating agents can be utilized in the cleaners used in the method of the present invention, the use of EDTA in skin cleaners presents some problems. These include: [0189] 1. EDTA appears on the EPA Hazardous Substances List under both the Clean Air Act and Clean Water Act categories. [0190] 2. EDTA appears on the California Hazardous Substances List. [0191] 3. EDTA is a skin and eye irritant, particularly at the elevated levels necessary to accomplish the desired level of metal removal. (However, this could be overcome by the addition of other ingredients to counter the chelates' irritation properties.)

[0192] EDTA is very costly to remove in wastewater treatment, because in order to precipitate any metals in the waste water, the EDTA must be destroyed. However, this is cannot be done on a consistent, economical basis. Chelates delivered to the waste water treatment plant pass right through the treatment process, resulting in the metals being discharged to the receiving waters.

[0193] 2. Phosphonates

[0194] It has been known for some time that cleaners of the types listed herein were effective at removing surface metals contamination along with the full spectrum of dirt and organic and inorganic soils encountered from the outer skin surface. With this method, utilizing the improved formulations of the types listed, in addition to removing surface contaminants, cleaners of this type also are capable of removing sub-surface skin contaminants by penetration and extraction. The use of phosphonates, particularly the organophosphonates, and other sequesterants, for example sorbic acid and its salts, as well as some of the unique properties of some quaternary ammonium compounds, such as benzalkonium chloride, when blended in a stable and compatible manner into quality skin cleaning formulations along with other typical components results in the improved removal of significant amounts of sub-surface heavy metals from the skin pores, sweat ducts and hair follicles.

[0195] Phosphonates according to the sales literature of the producers of phosphonates, are “versatile metal ion control agents” with potential uses in any application requiring a hydrolytically stable, water soluble product for sequestering calcium, magnesium and many other metal ions. They form stable molecules with sequestered metals over a broad range of pH. Phosphonates have been and are used in detergents, cosmetics and personal care products. They are used to control hardness ions, such as calcium, magnesium and iron and are very effective dispersants for solid materials to keep them suspended in water.

[0196] Phosphonates are more effective at deflocculation, dispersion and anti-redeposition of solids than the other chelating agents commercially available without the skin irritation that accompanies their use. They are as effective as the strongly irritating sodium tripolyphosphates and tetrasodium pyrophosphates at dispersing solid materials into suspensions in water. They also appear to provide an additional means to extract subsurface metals that the traditional chelating agents lack by providing a strong anionic (negative) charge that provides a very strong attraction for positively charged metal ions.

[0197] Phosphonates include the acids and salts of Aminotri (methylenephosphonic acid) (ATMP). The CAS name for ATMP is Phosphonic acid, nitrilotris (methylene) tri. Other phosphonates include: 1-Hydroxyethylidene-1, 1-diphosphonic acid (HEDP); Ethylenediaminetetra (methylenephophonic Acid) (EDTMP); Hexamethylenediaminetetra (methylenephophonic Acid), (HMDTMP); and Diethylenetriaminepenta (methylenephophonic Acid), (DETPMP), by way of examples.

[0198] Skin cleaners incorporating the types of ingredients listed above are Anti Static Metal Sequestering Skin Cleaners collectively referred to in this disclosure as “Type A” Anti Static Metal Sequestering Skin Cleaners. These Type A Skin Cleaners are water rinse able formulations.

[0199] 3. Terpenes

[0200] Another class of skin cleaners that are effective at performing these functions utilize terpenes, which are essential oils naturally produced by a wide variety of plants. Terpenes have bare oxygen atoms at one end of the long molecule which can acquire and hold a negative charge. This negative charge provides a strong means to attract, lift and hold metals and metal compounds and then hold them in suspension. Formulas utilizing terpenes may be blended with alkyl polyglucoside surfactants (non-ionic surfactants), or with the types of surfactants listed in the formulations of Type A, and together provide the necessary functions of lowering the surface tension of the water, wetting the metal and other contaminants and breaking the adhesive forces binding the metals to the skin surface and subsurfaces. When this base blend is combined with an alkanolamine, such as triethanolamine, an amine oxide and phosphonates, the resulting skin cleaner provides the same or better metal removing capacity as the Type A skin cleaning formulas listed above. The alkanolamine provides the benefits of metal sequestering, anti-redeposition and convert oils present on the skin into soaps.

[0201] Skin cleaners incorporating the types of ingredients listed above are Anti Static Metal Sequestering Skin Cleaners collectively referred to in this disclosure as “Type B” Skin Cleaners.

[0202] C. Optional Components

[0203] Skin cleaners of type A and Type B can also incorporate an abrasive to increase their exfoliation capability. Other components that can be added to these cleaning preparations include a preservative to extend the product's shelf life, moisturizers, humectants or emollients to make the product milder to the skin, colorant and fragrance to make the product more esthetically pleasing and an antibacterial agent to kill bacteria that reside on and in the upper layers of the skin.

II. Skin Cleaner Formulations

[0204] Phosphonate levels, chelate levels and combined levels of chelates and phosphonates that are effective in formulations of type A and B to maximize the metal removal capacity from the surface and subsurface range from 0.25% to 10.0%. They can be effective at levels as low as 0.1% when, for the purposes of this procedure if it is used for very low metal concentration levels and or in conjunction with soft water, do-ionized or distilled water. Formulations of types A and B are effective at meeting the objectives of this invention at levels up to 25%, with very hard water and very high levels of metals present They can be formulated over the entire pH range between 3.5 and 10.5.

[0205] While the use of phosphonates is preferred in these formula types, it can be readily understood by practitioners knowledgeable in the field that other chelates used singly or in common have the ability perform some or all of the necessary functions.

[0206] A. Examples of Preferred Skin Cleaner Formulations

[0207] To achieve a comparable low residual level effectiveness and removal of elevated levels of metals and metal compounds from the surface and subsurface, with EDTA or the other strong chelants (NTA, HEEDTA, DTPA, DEG and EDG); required concentrations appear to range from 0.5% to 25% by weight in the skin cleaning preparations, with 0.5% to 0.75% appearing to be the maximum concentration that avoids the skin irritation that accompanies the use of these chelant types in skin cleaners at levels above about 0.4%. A variety of liquid skin cleansers, commercially available from ESCA Tech, Inc. under the trademark D-Lead® are produced to remove lead, other heavy metals, the transition metals and arsenic from the skin quickly and efficiently, without any EDTA, and have a higher lead and metal removal capacity than other types of skin cleaners. It has unexpectedly been discovered that these formulations, as well as formulations of similar types are effective at removing not only surface skin contamination, but also the sub-surface skin contaminants of concern in the methods for collection of both capillary and venous blood samples.

[0208] These products include D-Lead® Hand Soap, item #: 4222ES, D-Lead® Deluxe Whole Body Wash and Shampoo, item #: 4224ES, D-Lead® Abrasive Hand Soap, item #: 4229ES and D-Lead Moisturizing Shower Gel, item #: 451ES, (Type A), which all have very high removal capacities for lead, cadmium, mercury, cobalt, nickel, silver, radium, uranium and other heavy metals, as well as calcium and magnesium for example.

[0209] All of these products are capable of complete removal of as much as 400 micrograms of lead oxide placed on the hands in a single 20 second wash and 10 second rinse in controlled lab tests. Tests with soaps containing EDTA at elevated levels removed about ½ to ⅔ of this amount (50% to 66% efficient). These results compare very favorably with, for example, Ivory® bar soap at less than 20 micrograms of lead oxide removal (5% efficient) and Dial® Antibacterial Hand Soap which removed less than 120 micrograms (30% efficient) in the same controlled lab tests.

[0210] 1. Type A Skin Cleansers

[0211] The following skin cleaner formulations have similar surfactant systems, and are classified as Type “A” Anti Static Metal Sequestering Skin Cleaners and are water rinsed skin cleansers.

[0212] The label of D-Lead Hand Soap, item #: 4222ES, states: REMOVES LEAD, and: ALSO REMOVES NICKEL, CADMIUM, ARSENIC, MERCURY, SILVER, ZINC AND MOST OTHER HEAVY METALS. The ingredients list on the bottle is: Water, Sodium Laureth Sulfate, Sodium Linear Alkyl Sulfonate, Cocamidopropyl Betaine, Sodium Phosphonate, Sodium Chloride, Cocamide DEA, Parachlorometaxylenol, Propylene Glycol, Fragrance, D & C Red #27.

[0213] The label of D-Lead Deluxe Whole Body Wash, item #: 4224ES, states: REMOVES LEAD, and: ALSO REMOVES NICKEL, CADMIUM, ARSENIC, MERCURY, SILVER, ZINC AND MOST OTHER HEAVY METALS. The ingredients list on the bottle is: Water, Sodium Laureth Sulfate, Sodium Linear Alkyl Sulfonate, Cocamide DEA, Cocamidopropyl Betaine, Sodium Chloride, DMDM Hydantoin, Sodium Phosphonate, Parachlorometaxylenol, Propylene Glycol, Fragrance, D & C Orange #4.

[0214] The label of D-Lead Abrasive Hand Soap, item #: 4229ES, states: REMOVES LEAD, and: ALSO REMOVES NICKEL, CADMIUM, ARSENIC, MERCURY, SILVER ZINC AND MOST OTHER HEAVY METALS. The ingredients list on the bottle is: Water, Abrasive, Magnesium Aluminum Silicate, Sodium Linear Alkyl Sulfonate, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Quaternium 15, Sodium Chloride, Sodium Phosphonate, Coco Diethanolamide, Lauramine Oxide, D & C Orange #4.

[0215] The label of D-Lead Moisturizing Shower Gel, item #: 451ES states: REMOVES LEAD, and ALSO REMOVES NICKEL, CADMIUM, ARSENIC, MERCURY, SILVER, ZINC AND MOST OTHER HEAVY METALS. The ingredients list on the bottle is: Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, PEG-150 Distearate, Potassium Cocoate, Cocamidopropylamine Oxide, Glycerin, Sodium Chloride, DMDM Hydantoin, Fragrance, Sodium Phosphonate, FD&C #5 Yellow, FD&C #1 Blue.

[0216] 2. Type B Skin Cleansers

[0217] The following skin cleaner formulations may be used with or without a water rinse; they have similar surfactant systems, and are labeled for the purposes of this discussion as Type “B” Anti Static Metal Sequestering Skin Cleaners.

[0218] D-Lead® Dry or Wet Skin Cleaner, item #: 4460ES, and D-Lead® Dry or Wet Skin Cleaner with Abrasive, item #: 4455ES (Type B) also may be used since they remove lead and other heavy metals and arsenic from the skin quickly and efficiently, without any EDTA, and have a higher lead and metal removal capacity than other skin cleaners. These products are typically applied to dry skin, washed, then removed with a towel (when no water is available) or may be rinsed off with water. Testing indicates that the lead removal capacity from the hands is in excess of 400 micrograms in a single second wash and 20 second wiping as well as in a single wash and 20 second clean water rinse. In field tests with 11 battery workers, we were able to remove as much as 29.5 milligrams of lead from a single hand in one cleaning with D-Lead® Dry or Wet Skin Cleaner (#4460ES), with an average of 4.54 milligrams of lead removed by the dry method. It was noted that the individual with the 29.5 mg of lead removal from the one hand had extremely rough, dry chapped hands, with a tremendous surface area available for lead from the job as well as from body stores via sweat to accumulate.

[0219] The label of D-Lead® Dry or Wet Skin Cleaner, item #: 4460ES states: REMOVES LEAD, and: ALSO REMOVES NICKEL, CADMIUM, ARSENIC, MERCURY, SILVER, ZINC AND MOST OTHER HEAVY METALS. The ingredients list on the bottle is: Water, Natural Organic Oil Blend, Alkyl Polyglucoside, Triethanolamine, Lanolin, Carbomer, Amine Oxide, Sodium Phosphonate, Propylene Glycol, PCMX, Fragrance, FD&C Green #3.

[0220] The label of D-Lead® Dry or Wet Skin Cleaner with Abrasive, item #: 4455ES states: REMOVES LEAD, and: ALSO REMOVES NICKEL, CADMIUM, ARSENIC, MERCURY, SILVER, ZINC AND MOST OTHER HEAVY METALS. The ingredients list on the bottle is: Water, Natural Organic Oil Blend, Alkyl Polyglucoside, Abrasive, Triethanolamine, Lanolin, Carbomer, Amine Oxide, Sodium Phosphonate, Propylene Glycol, PCMX, Fragrance, FD&C Green #3.

[0221] Formulas of these types also have a very high metal removal capacity and break the adhesion of the metals on the surface of the skin and in the pores of the skin and float the lead off the skin efficiently. They also efficiently mobilize large quantities of metal contaminants from both the surface and subsurface of the skin.

[0222] B. Methods of Use of Type A and Type B Skin Cleansers

[0223] In a first embodiment of the method, the D-Lead® “Type A” Anti Static Metal Sequestering Skin Cleaners are applied to the skin to wash the area that is to be penetrated to obtain the blood sample. The skin may be either pre-wetted or not. The sample area as well as a large area surrounding the stick site is washed thoroughly for 20 to 30 seconds and then the skin is rinsed with clean water and dried with a towel or cloth that is as free of the metal contaminant(s) of concern as is economically and technically feasible. The water may be hard, soft, do-ionized or distilled. The skin may also be dried with a blower, provided the drying air is free of dust, such as the air quality obtained with the use of high efficiency air filters.

[0224] In a second embodiment of the method, the D-Lead® “Type B” skin cleaners are applied to the skin to wash the area that is to be penetrated to obtain the blood sample. The skin may be either pro-wetted or not. It appears that applying this cleaner to dry skin provides the greatest quantity of metal contaminant removal. These cleaners are effective at removing metal contamination with or without water. This is particularly useful when samples must be collected at a location without clean water.

[0225] In still a third embodiment of the method, the Skin Cleaner of Type B is applied to the dry skin, and spread with clean gauze, paper towel or cloth to cover the sample area as well as a large area surrounding the stick site. Alternately, it may be spread with clean hands or with clean, gloved hands. The skin cleaner is rubbed over and into the skin. In the case of particularly dry or damaged skin, it may be necessary to apply more of the cleaner, as this cleaner can be adsorbed into skin that is very dry. After the cleaner has had 30 seconds to work, the cleaner along with the metal contaminants is removed by wiping with a clean, low metal content fabric, gauze, paper or cloth. It is beneficial if the substrate selected will bind the metals and provide a level of mild mechanical abrasion to assist in the exfoliation of the dead cells. Alternately, the cleaner and the metal contaminants can be rinsed off with clean water then dried as described for cleaners of “Type A.”

[0226] In another fourth embodiment of the method, the skin can be cleaned sequentially with a Type A Skin Cleaner followed by a second cleaning with a Type B Skin Cleaner, or alternately, with type B, followed by Type A. In practical terms, it appears that the major benefits can be obtained by use of either a Type A Skin Cleaner, or a Type B Skin Cleaner, followed by a cleaning with the pre-moistened towel described below.

[0227] C. Skin Cleaning Wines

[0228] For maximum metal contaminant removal, this washing step around the area of the stick site should be followed with a cleansing with a premoistened wipe of the type described below prior to the alcohol wipe. Premoistened wipes with high lead and heavy metal removal capacity are also commercially available from ESCA Tech, Inc., under the trademark D-Wipe®. The label on the container of D-Wipe® Towels states: —Removes Lead, Nickel, Cadmium, Arsenic, Silver, Mercury, Zinc and most heavy metals form skin and surfaces. It also states: D-Wipe® Towels were specially designed for immediate clean up of lead and metals without water.—Gentle to our skin. The ingredient list states: Deionized water, SD Alcohol 40, Benzalkonium Chloride, Sodium EDTA, Sorbic Acid, Cocamide DEA, Fragrance, Aloe. These wipes do contain Sodium EDTA, which aids in the transfer of metals from the surface and to some extent the subsurface to the fabric, and assist in binding it tightly to the fabric substrate.

[0229] In this formulation for the wipes, the ingredients collectively provide the same steps as the Type A and Type B skin cleaners described previously and fulfill many of the same functions, along with some additional benefits. In particular, the same or better performance can be achieved with a combination of EDTA, phosphonates, sorbates and citrates or phosphonates without EDTA, and with or without the citrate or sorbate, or many combinations and concentrations of chelating and/or sequestering agents. Other chelating agents can be used, provided they are compatible and safe for use in a skin cleaner formula, such as NTA, HEEDTA, DTPA, DEG, EDG, citrates and gluconates, by way of example, and is intended to provide examples, but not to be an all inclusive list. Many of these appear to have potential to provide the same, similar or better functionality and performance as the phosphonates. Sequesterants including the phosphonates and phosphonic acids previously listed also will provide a means to transfer metals from the skin and bind them to an appropriate substrate. The sorbate is a mobilizing agent for metals that aids in breaking their adhesion to the skin surface, provides some sequestering functionality and also provides an anti-oxidizing function to the formula components.

[0230] The use of benzalkonium chloride, and/or a mixture of quaternary ammonium compounds provide an anti-static function to bleed off static charges that attach metals to the skin surface. Other examples of anti-static agents that can be utilized to fulfill this function are the Polydimethylsiloxanes (PDMS), other silicone derivatives, the betaines and amine oxides.

[0231] The ethanol contributes benefits in addition to forming part of the carrier for the other ingredients, it also provides emulsification of the oils and grease, a reduction in the tackiness of the skin surface aiding in the release of the metals and aiding in site disinfection. As discussed previously alcohols have a tendency to shrink the size of the pore openings due to the localized surface cooling that occurs as it evaporates. In these types of formulas, this function is delayed throughout the cleaning/wiping process, as the alcohol does not tend to evaporate until the wipe is removed, allowing skin exposure to the air. Meanwhile, the pores remain open for cleaning and subsurface removal. The wipe substrate should preferably be composed of cotton, cellulose, or other absorbent material, preferably a blend of rayon and polyester that is able to bind the metals to the fabric so they are removed from the surface and not spread by smearing across the skin surface during wiping. Wipes of this type are designated as Anti Static Metal Sequestering Wipes, Type 1. They dry by evaporation, and do not require an additional rinsing or drying step.

III. Experimental

[0232] The use of ordinary soaps or skin cleaners to clean the skin prior to the use of the alcohol wipe to remove heavy metals is less effective than the cleaners of the type described here. Our studies show that ordinary soaps remove insignificant amounts of lead from the skin. Ordinary soap is made from animal or vegetable fats and caustic soda (NaOH). For example Ivory® Bar Soap removes less than 5% of the lead oxide applied to the skin in our laboratory tests. In addition, bar soaps can also transfer the small quantity of lead removed to the next user.

[0233] We have also determined that common liquid skin cleansers, e.g. liquid Dial® Soap and SoftSoap® also remove very little lead from the skin, i.e., less than 30%. The reason that these soaps have very little lead removal capacity is that they were designed, formulated and optimized to remove common skin contaminates, such as natural skin oils and ordinary soil. They do not have sufficient anti static or metal sequestering capacity to remove large amounts of metals, or small amounts thoroughly. They are ineffective at deep cleaning metals from the subsurface of the skin. Lead and the other metals behave differently. Soaps and skin cleaners of the types listed as examples above have little ability or capacity to wet most metals, metal oxides and metal salts and float them off or surfaces or out of porous structures. Removal of metals from the skin surface and subsurface requires that the cleaning agent efficiently and effectively wet the metal bearing particles and then float them off the surface, out of the subsurface and up into the rinse water or wiping material. It is also beneficial if the cleaner is able to penetrate and extract subsurface metals.

[0234] In the presence of large quantities of metals on and in the skin, it is necessary to sequester or chelate the calcium, magnesium, iron and manganese present on and in the skin originating from environmental sources, from sources generated within the body and in the water used for washing and rinsing. Once these hardness ions and particles are “neutralized” by the sequesterants, chelants and/or surfactants, there must be sufficient capacity remaining after removal of the hardness ions to act on the other metals of concern. The phosphonates in the formulas of Type A and Type B provide a number of novel functions when utilized in skin cleaners to provide both high capacity and enhanced removal of metals from the surfaces of the skin. These properties include: dispersion of solid particles away from and out of the skin surface, penetration, extraction, deflocculation and anti-redeposition. They also provide the ability to peptize, or disperse fine particles and form colloidal suspensions. It appears that this attribute also aids in lifting and dispersing the dead, desiccated skin cells that form the outer surface of the skin, and removing the associated metals contained in the interior of these cells. Phosphonates in these formulas also have very high stability constants for calcium, magnesium, lead, manganese, strontium, barium, iron, cobalt, nickel, copper, zinc, thorium and cadmium, among others.

[0235] A. Methods of the Use Skin Cleaning Preparations of these Types to the Preparation of a Blood Sample Stick Site

[0236] 1. Venous Blood Samples

[0237] One method of preparing and cleansing the stick site prior to obtaining a venous blood sample may be done as follows: [0238] 1. Prior to entering the room or area where the sample will be collected roll up the shirt sleeves and wash both hands and forearms past the elbow with a Type A Anti Static Metal Sequestering Skin Cleaner. Rinse thoroughly with clean water. Dry with a clean, low lint, low metal towel or cloth. Alternately, the hands and arms may be cleaned with a Type B Skin cleaner first. [0239] 2. Proceed to the sample collection area or room, where the stick site is washed by the phlebotomist who inserts the following steps into the standard sampling procedure immediately before application of the tourniquet: The phlebotomist puts on clean gloves and applies approximately 7 mL (¼) ounce of a Type B Anti Static Metal Sequestering Skin Cleaner to the area of the vein to be sampled and with a gauze sponge spreads the cleaner over an area approximately 75 mm in diameter centered on the stick site. Use the gauze sponge to work the cleaner into the skin in a circular motion for 5 seconds. Discard this gauze and this pair of gloves. Allow the cleaner to reside on the skin for 20 to seconds and don a new pair of gloves. [0240] 3. If too much of the Type B skin cleaner is absorbed due to very dry skin, apply an additional 7 mL and wait an additional 30 seconds. Remove the skin cleaner with a second gauze sponge. Wipe up in a circular motion from the center outwards. Repeat with a second gauze sponge. Discard the sponges. Discard this pair of gloves. Alternately, the area of the stick site can be cleaned with a Type A skin cleaner with subsequent rinsing and drying steps. [0241] 4. Don a new pair of gloves and clean the stick site and area extending out from the stick site to clean a total area of 75 mm in diameter with the stick site as the center of the circle using a pre-moistened towel. Use a Type 1 Anti Static Metal Sequestering Wipe Towel. Fold the towel to a size no larger than 75 mm×75 mm and clean from the center outwards in a circular motion. Use gentle pressure to exfoliate dead cells. [0242] 5. Discard the wipe and don a new pair of gloves to proceed with the tourniquet and alcohol wipe steps and collecting the blood sample. [0243] 6. In an occupational setting, it will be advantageous to have the individual shower and wash their entire body with a Metal Sequestering Skin cleaner of Type A and change into clean clothes in place of washing only the hands and arms. [0244] 7. In another variation of this procedure, an Anti Static Metal Sequestering Wipe of Type 1 is used immediately before the Type B skin cleaner to exfoliate dead skin cells and assist in unblocking the pores. [0245] 8. The various cleaning formulas disclosed in this application may be used in a different order and this example illustrates some of the many possible variations of the method that will be effective. The practitioner can readily see from this example that different variations of this procedure have the capability of producing the same or similar end results.

[0246] 2. Capillary Blood Samples

[0247] a. One method of preparing and cleansing the stick site prior to obtaining a capillary blood sample may be done as follows: [0248] 1. If a finger is to be the sample location—both hands are washed by either the patient or the phlebotomist with a Type A Metal Sequestering Skin Cleaner. Rinse thoroughly with clean water. Dry with a low lint, low metals towel or cloth. If washed by the phlebotomist, then the phlebotomist should don a new pair of gloves first. [0249] 2. If the ear lobe, heel or toe is to be the stick site, then the phlebotomist wearing a new pair of gloves washes the foot or the ear with a Type A Metal Sequestering Skin Cleaner. Rinse thoroughly with clean water. Dry with a low lint metals free towel or cloth. [0250] 3. The phlebotomist dons a new pair of gloves and cleans the finger, heel, toe or ear lobe around the stick site with a Metal Sequestering Wipe of Type 1. The towel should be folded to a size no larger than 75 mm×75 mm and an area extending beyond the stick site is cleaned with gentle pressure and a circular motion, with the stick site as the center and wiping outwards.

[0251] b. Another method for cleaning the stick site is: [0252] 1. The phlebotomist wearing a new pair of gloves washes the hand, foot or the ear according to the location of the stick site with a Type B Metal Sequestering Skin Cleaner using between 3 and 7 mL of skin cleaner. Apply the skin cleaner with a new cotton gauze sponge, or other mildly abrasive fabric that is both absorbent and adsorbent, working from the center of the stick site outwards for 5 seconds. Allow the cleaner to work for 20 to 30 seconds. [0253] 2. The phlebotomist should don a new pair of gloves and with a new cotton gauze sponge remove the skin cleaner with a circular motion from the center outwards, while applying gentle pressure. [0254] 3. The phlebotomist then dons a new pair of gloves and cleans the finger, heel, toe or ear lobe around the stick site with a Metal Sequestering Wipe of Type 1. The towel should be folded to a size no larger than 75 mm×75 mm and an area extending beyond the stick site is cleaned with gentle pressure and a circular motion, with the stick site as the center and wiping outwards.

[0255] B. Efficacy of certain Skin Cleaning Compounds at Removal of Lead

[0256] Askin, D P and Volkmann, M in “Effect of Personal Hygiene on Blood Lead Levels of Workers at a Lead Processing Facility”, Amer. Ind. Hyg, Assoc. J, (1997), 752-753 used a product that is now commercially available as D-Wipe® Towels to measure the amount of lead on the right hand of workers and found a highly significant correlation between the quantity of lead recovered from the hand and the worker's blood lead level. (Positive correlation coefficient was 0.61 and p<0.002). These tests also demonstrated the ability of the D-Wipe® Towels to remove lead from the hands. One D-Wipe® Towel recovered as much as 4.41 mg of lead from a single hand of a lead worker.

[0257] 1. Comparison of Lead Removal of Alcohol Prep Pad and D-Wipe® Towel

Purpose

[0258] We have also evaluated the effectiveness of an isopropyl alcohol wipe in removing lead from the surface of the skin and compared it to the effectiveness of the D-Wipe® Towel in removing lead from the skin. Askin, D., Dorko, Z s. and Erdelyi, O. (not published) tested 22 battery workers during a work day.

Procedure

[0259] The amount of lead removed from the inside of the elbow was determined for alcohol prep pads and D-Wipe® Towels for 22 battery plant workers. Workers reported to the cafeteria during their work shift. After cleaning their hands, they were instructed to roll up their shirt sleeve. The technician selected a visible vein inside the elbow and cleaned a 1″×2″ area, centered on the selected stick site, with an alcohol prep pad, simulating the procedure to prep the stick site for a venous sample. The pad was subsequently analyzed for total lead by ICMS.

[0260] Then, a D-Wipe® Towel was folded into a 1″ square, and the exact same area was cleaned again. The D-Wipe® Towel was subsequently analyzed for total lead by ICMS.

[0261] In 21 of 22 individuals sampled, more lead was recovered with the D-Wipe® Towel than with the alcohol wipe. The amount of recovered lead with the alcohol wipe ranged from 0.5 to 200 micrograms of lead with an average of 23 micrograms. The amount of lead recovered with the subsequent cleaning of the same area with a D-Wipe® Towel ranged from 3.3 to 460 micrograms, with an average of 47 micrograms.

Results

[0262]

TABLE-US-00004 Average lead removed by Alcohol Prep Pad: 23 micrograms Average lead removed by subsequent 47 micrograms D-Wipe ® Towel: Range of Lead removed by Alcohol Prep Pad: 0.5 to 200 micrograms Range of Lead removed by subsequent 3.3 to 460 micrograms D-Wipe ® Towel:
Results are listed in the order of increasing blood lead level, based on the last test result for the subject.

TABLE-US-00005 TABLE 4 Lead Removed by Alcohol wipe and D-Wipe ® Towel Alcohol D-Wipe ® Blood # Wipe Towel Total Lead Test μg Lead μg Lead μg Lead Level Subject Recovered Recovered Recovered μg/dL 2 0.5 3.3 3.8 7 20 0.8 6.0 6.8 10 18 1.4 9.2 10.6 11 16 16.0 65.0 81.0 12 14 12.0 24.0 36.0 13 10 0.7 4.3 5.0 14 7 2.4 5.2 7.6 14 12 25.0 72.0 97.0 14 9 25.0 40.0 65.0 15 15 0.9 4.8 5.7 16 21 0.5 3.9 4.4 17 19 0.5 4.3 4.8 18 8 11.0 22.0 33.0 18 6 11.0 16.0 27.0 19 13 15.0 64.0 79.0 19 17 1.4 9.2 10.6 21 11 18.0 31.0 49.0 22 1 29.0 46.0 75.0 22 5 19.0 38.0 55.0 27 4 12.0 22.0 36.0 28 22 200.0 460.0 660.0 28 3 112.0 90.0 202.0 39 Averages: 23.4 47.2 70.6 18.4

Observations

[0263] From the skin of 21 of 22 individuals, the D-Wipe® Towel removed more lead from the skin of the sample area than the alcohol prep pad. It is also interesting to note the tendency of the amount of lead removed from the skin at the stick site to increase with increasing blood lead level. In general, the higher the blood lead level, the higher the amount of lead recovered from the skin. This is a very strong indication of the recovery of subsurface lead which could have originated from the excretion of body stores. It also indicates the quantity of potential sample contamination increases with blood lead level. The higher the individual blood lead level, the higher the potential for more lead to be present at the stick site and the higher the amount of lead that was recovered from the stick site.

[0264] For one individual, the alcohol wipe removed more lead than the D-Wipe® Towel. Two observations were recorded on this individual at the time: (1) he had the highest blood lead level in the group: a blood lead level 11 μg/dL higher than anyone else. (2) His skin texture was noticeably different—he had very moist, tight skin with very few ridges or wrinkles, i.e., a much lower total surface area than the other individuals, no hair on his arms and very small skin pores.

Conclusion

[0265] Cleaning the stick site with a D-Wipe® Towel prior to the alcohol prep pad will result in more lead removal from the area of the stick site than the alcohol prep pad normally used. The D-Wipe® Towel has a superior ability to mobilize lead so that it can be absorbed onto and into the wipe substrate, where it can be firmly bound to the fabric. The D-Wipe® Towel must be mobilizing lead that was inaccessible to the alcohol wipe. Based on the subsequent venous sample study, it appears that this process works well with the D-Wipe® Towel wiping followed by the alcohol wipe.

[0266] 2. Lead Removal Capacity of D-Lead® and D-Wipe® Skin Cleaners

Purpose

[0267] We purchased two dozen commercially available soaps and skin cleaners and twenty commercially available pro-moistened skin cleaner wipe towelettes and compared their lead removal capacity to the removal capacity of D-Lead® Skin Cleaners, Type A and Type B and D-Wipe® Towels. The purchased products were selected to represent a wide variety of formulation types based on the ingredients listed on the product labels. The purchased cleaners were evaluated for their removal capacity for lead oxide from the skin. The purchased skin soaps and cleaners were compared to the D-Lead® formulations and the D-Wipe® Towels were compared to the purchased towelettes.

Procedure

[0268] For the skin cleaner tests, a measured amount of lead oxide (PbO) was applied to the palm of one individual, who then massaged the material into the palm with the opposite index finger. The hands were then rinsed with warm water for 10 seconds, with no attempt to measure the amount that rinsed off with the tap water. Then 4 mL of the liquid soap was applied and the hands washed for 20 seconds, followed by a 10 second rinse.

[0269] For the skin cleaners and soaps, the amount of lead remaining on the palm of the closed hand was then tested by applying a chemical spot test (D-Lead® Lead Test Kit, mfg by ESCA Tech, Inc., Milwaukee, Wis.) directly on the palm of the hand. This test turns lead and lead compounds a bright yellow color, and has a visible detection limit of micrograms as Pb. The % removal efficiency was estimated based on a semi-quantitative scale developed by recovering the lead from the first 15 tests with a D-Wipe® Towel and analyzing them for total lead.

Results

[0270] For the purchased skin cleaners, the lead residue remaining ranged from a low of approximately 95% to 50% (removal rate of 5% to 50%). For all of the D-Lead® Skin Cleaners listed as type A and type B, no detectable lead remained on the palm or the opposite forefinger.

[0271] For the wipes, the same procedure was used and for the purchased wipes, the lead residue remaining ranged from 97% to 15% (removal rate of 3% to 85%). For the D-Wipe® Towels no detectable lead residue remained on the skin.

[0272] 3. Field Performance Testing of D-Lead® Skin Cleaners. Types A and B and D-Wipe® Towels

[0273] We tested the performance of one Type A and one Type B skin cleaner on 20 battery plant workers. During their work shift, individuals reported to the training room to determine how much lead they had accumulated on their hands while working. D-Wipe® Towels, D-Lead® Deluxe Whole Body Wash (#4224ES) and D-Lead® Dry or Wet Skin Cleaner (#4460ES) were used in the tests.

[0274] a. Deluxe Whole Body Wash Group

Procedure

[0275] Nine (9) of the workers were brought into the test room without their gloves directly from the production floor without washing. The left hand of each worker was cleaned three times with successive D-Wipe® Towels by a technician, up to their wrist. After their left hand was cleaned, these workers washed both hands with #4224ES, D-Lead® Deluxe Whole Body Wash and Shampoo. They rinsed their hands for 10 seconds, then 7 mL of soap was applied, they washed for 20 seconds up to their wrists and rinsed for 10 seconds. (The amount of lead removed was not determined, as it was contained in the rinse water). The amount of lead remaining on their right hand was determined with three successive cleanings of their right hand up to their wrist with three separate D-Wipe® Towels. For each individual, the three pre-wash D-Wipe® Towels were combined into one sample container and the three post wash towels were combined into a second container and analyzed by GFAAS for total lead.

Results

[0276]

TABLE-US-00006 Highest level of lead removed with the D-Wipe ® Towels  3.5 milligrams from the first (left) hand for these 9 workers: Average amount of lead on the left hand of these 9  1.2 milligrams workers: Average amount of Lead on right hand after washing 0.04 milligrams with D-Lead ® Deluxe

TABLE-US-00007 TABLE 5 Lead Removal Capacity of D-Lead ® Deluxe μg Lead Recovered μg Lead from right hand after 1 Test on Left Hand wash with D-Lead % Individual # before Washing Deluxe Removed 1   37.4 ND 99.9% 2   43.7 ND 99.9% 3   167.3 ND 99.9% 4   205.5 ND 99.9% 5   781.5 ND 99.9% 6 1,174.3 124.0 89.4% 7 1,507.3 70.7 95.3% 8 3,388.8 2.8 99.9% 9 3,492.0 130.6 96.3% Avg.: 1,199.8 97.8% * Minimum detection limit [MDL] = 20 μg by GFAAS ND = Non Detectable

Conclusion

[0277] With proper washing technique, 97.8% of the estimated lead on their hand was removed with a single hand wash with skin Cleaner Type A, #4224ES, D-Lead Deluxe Whole Body Wash and Shampoo.

[0278] b. Dry or Wet Skin Cleaner Group

Procedure

[0279] Ten workers were brought into the test room without their gloves directly from the production floor without washing. After cleaning their left hand with the three D-Wipe® Towels according to the procedure described above, their right hand was cleaned by the technician. The technician dispensed 7 mL of #4460ES, D-Lead® Dry or Wet Skin Cleaner onto their right hand. The cleaner was applied to their dry hands by the technician, and the technician wearing a fresh pair of vinyl gloves for each individual, massaged and cleaned their hand for 20 seconds. Then, the cleaner was removed with a 4″×4″ cotton gaze sponge. The gauze was then analyzed by GFAAS. The right hand was then cleaned again with a D-Wipe® Towel and analyzed for lead. The results of the analysis of the gauze were used to determine the amount of lead removal.

Results

[0280]

TABLE-US-00008 Highest lead recovered from right hand with #4460ES: 29.5 milligrams

TABLE-US-00009 TABLE 6 Removal Capacity of D-Lead Dry or Wet μg Lead μg Lead Recovered % Additional Test recovered from left from right hand after 1 Lead Removed Individual hand with D- wash with D-Lead Dry by D-Lead #: Wipe Towels or Wet Dry or Wet 10 9,419.7 29,505.2 213.2% 11 2,017.5 5,534.8 174.3% 19 1,440.7 4,802.3 233.3% 13 1,651.2 3,437.2 108.2% 14 958.0 2,571.5 168.4% 15 1,970.8 2,505.0  27.1% 18 262.1 553.6 111.2% 17 113.1 363.7 221.6% 18 79.0 290.4 267.6% 19 55.7 240.5 331.8% 20 59.1 100.7  70.4% Averages: 1,638.8 4,536.8 175.2%

Observations

[0281] The amount of lead recovered from the hand with the Dry or Wet Skin cleaner was highest for those individuals with dry, cracked, rough skin. This corresponded with the net total surface area, that is, the higher the surface area, the higher the amount of lead present and recovered. It could not be determined if the lead removal capacity of the D-Lead® Dry or Wet Skin cleaner is actually superior to the lead removal capacity of the D-Wipe® Towels; or if there was this much difference in the lead loading between the two hands, or if D-Lead Dry or Wet Skin Cleaner is a superior deep cleaning formula for metals.

Conclusions

[0282] D-Lead Dry or Wet Skin Cleaner appears to remove lead from deep in the skin. Substantial quantities of lead are present on the hands of lead workers even when wearing gloves. Lead level on one hand can exceed 10 milligrams, when the surface area is sufficiently large due to rough cracked skin.

[0283] 4. Lead Suppression Analysis

Purpose

[0284] To assess whether D-Lead® Deluxe Whole Body Wash and Shampoo, #4224ES; D-Lead® Dry or Wet Skin Cleaner #4460ES; or D-Wipe® Towel liquid materially impacts the blood lead result by suppressing the amount of lead available for analysis resulting in a decreased blood lead analytical result. It would be potentially feasible for the residue of a skin cleaner, if incorporated into a blood sample to result in matrix interference during analysis and suppress the quantity of metal detected.

Procedures

[0285] Control specimens (100 μl blood sample, 900 μl matrix modifier) were prepared and analyzed in the customary manner by Graphite Furnace Atomic Absorption Spectroscopy (GFAAS). The known control values were 6.0, 10.0 and 14.0 μg/dL after dilution. Test samples were aggressively prepared by diluting control specimens using a 1:1 ratio (50 μl sample, 50 μl D-Lead® Product and 50 μl D-Wipe® liquid; and 900 μl matrix modifier) and then analyzed in the customary manner.

Conclusion

[0286] When we compare each of the test sample results with its respective control value, the noted difference for each comparison falls within the detection limits of the GFAAS instrument (+/−1 μg/dL). Based upon the results we concluded that utilization of D-Lead Skin Cleaner, D-Lead® Dry or Wet Skin Cleaner and D-Wipe® Towels do not materially impact the blood lead result or cause any matrix interference.

[0287] 5. Comparison of the D-Lead®-D-Wipe® Stick Site Cleansing Protocol for Venous Blood Lead Samples vs. the Centers for Disease Control Stick Site Cleansing Protocol

Objective

[0288] To compare the level of accuracy achieved with a D-Lead®-D-Wipe® (DLDW-VP) Venous Stick Site Cleansing Protocol for venous blood lead sample collection with the accuracy of the standard CDC recommended Venous Stick Site Preparation Protocol (CDC-VP).

Procedure

[0289] During scheduled blood lead testing at a lead battery manufacturer, 30 volunteers were recruited to provide two (2) venous samples, one from each arm. Workers were tested during their work shift, and were asked not to wash their hands, arms and face (as is customary anytime they leave the plant floor) prior to coming in for their blood lead test. This is consistent with the CDC protocol. Of the 30 volunteers, 29 were able to supply 2 blood samples. The first sample was collected from their right arm vein according to the CDC protocol as published by the web site: Internet Pathology Laboratory for Medical Education (IPLME). http://medlib.med.utah.edu/WebPath/TUTORIAL/PHLEB/PHLEB.html

[0290] For the first sample, collected from their right arm, the IPLME protocol for collecting a venous blood lead sample (CDC-VP) quoted below was followed.

[0291] Procedure for Vein Selection: [0292] Palpate and trace the path of veins with the index finger. Arteries pulsate, are most elastic, and have a thick wall. Thrombosed veins lack resilience, feel cord-like, and roll easily. [0293] If superficial veins are not readily apparent, you can force blood into the vein by massaging the arm from wrist to elbow, tap the site with index and second finger, apply a warm, damp washcloth to the site for 5 minutes, or lower the extremity over the bedside to allow the veins to fill.

[0294] Performance of a Venipuncture: [0295] Approach the patient in a friendly, calm manner. Provide for their comfort as much as possible, and gain the patient's cooperation. [0296] Identify the patient correctly. [0297] Properly fill out appropriate requisition forms, indicating the test(s) ordered. [0298] Verify the patient's condition. Fasting, dietary restrictions, medications, timing, and medical treatment are all of concern and should be noted on the lab requisition. [0299] Position the patient. The patient should either sit in a chair, lie down or sit up in bed. Hyperextend the patient's arm. [0300] Apply the tourniquet 3-4 inches above the selected puncture site. Do not place too tightly or leave on more than 2 minutes. [0301] The patient should make a fist without pumping the hand. [0302] Select the venipuncture site. [0303] Prepare the patient's arm using an alcohol prep. Cleanse in a circular fashion, beginning at the site and working outward. Allow to air dry. [0304] Grasp the patient's arm firmly using your thumb to draw the skin taut and anchor the vein. The needle should form a 15 to 30 degree angle with the surface of the arm. Swiftly insert the needle through the skin and into the lumen of the vein. Avoid trauma and excessive probing. [0305] When the last tube to be drawn is filling, remove the tourniquet. [0306] Remove the needle from the patient's arm using a swift backward motion. [0307] Press down on the gauze once the needle is out of the arm, applying adequate pressure to avoid formation of a hematoma. [0308] Dispose of contaminated materials/supplies in designated containers. [0309] Mix and label all appropriate tubes at the patient bedside. [0310] Deliver specimens promptly to the laboratory.

[0311] The blood lead level results for the venous samples collected by the CDC/IPLME protocol are listed in Tables 7 and 8 and labeled CDC-VP for CDC Venous Blood Sample Stick Site Cleansing Protocol.

[0312] The second sample was collected from their left arm vein, and the phlebotomist followed the same procedure as listed above, with the following additional steps, immediately before the application of the tourniquet:

[0313] a. Three (3) ml of D-Lead® Dry or Wet Skin Cleanser, formula #: 4460-ES was dispensed from a syringe onto the inside of the elbow over the selected vein, centered on the stick site. It was spread with a sterile cotton gauze sponge. It was allowed to sit undisturbed for 30 seconds, while the phlebotomist donned a new pair of gloves and then was wiped off with a new sterile cotton gauze sponge in a spiral, circular motion from the center of the stick site outwards.

[0314] b. After the phlebotomist donned a new pair of gloves, a folded D-Wipe® Towel was used to clean the stick site, also in a spiral, circular motion for 5 seconds.

[0315] The blood lead sample results for the venous blood samples collected by this protocol is listed in Tables 7 and 8 under the column headed DLDW-VP for the D-Lead®-D-Wipe® Venous Stick Site Cleansing Protocol.

[0316] The venipuncture samples for both protocols were collected in lavender topped VACUTAINER® tubes containing EDTA as the anti-coagulant and 20 mL of blood was collected in each sample tube. All samples were shipped the same day via overnight service to the laboratory. They were analyzed at the same CLIA (Clinical Laboratory Improvement Amendments) licensed Laboratory on the same day, in the same run by GFAAS. One of the 30 subjects was not able to supply a second blood lead sample and is excluded from the data analysis. The analytical accuracy that can be achieved in the laboratory is +/−1 μg/dL.

Results

[0317] The complete set of data is listed below in Table 7. All blood results are in micrograms of lead per deciliter of blood. The percent difference is calculated as:

[00001]$\frac{\left[\mathrm{DLDW}.Math.\text{-}.Math.\mathrm{VP}\right]-\left[\mathrm{CDC}.Math.\text{-}.Math.\mathrm{VP}\right]}{\left[\mathrm{DLDW}.Math.\text{-}.Math.\mathrm{VP}\right]}*100$

TABLE-US-00010 TABLE 7 Venous Sample Test Data Blood Lead μg/dL Test DLDW- CDC- Difference % Subject #: VP VP μg/dL Difference 1 24.5 27.8 −3.3 −13.5% 3 32.0 34.0 −2.0  −6.3% 4 18.1 19.2 −1.1  −6.1% 5 18.4 19.2 −0.8  −4.3% 6 18.9 21.4 −2.5 −13.2% 7 15.7 22.7 −7.0 −44.6% 8 24.6 25.5 −0.9  −3.7% 9 40.4 43.8 −3.4  −8.4% 10 16.2 18.6 −2.4 −14.8% 11 24.7 26.5 −1.8  −7.3% 12 26.7 28.4 −1.7  −6.4% 13 15.8 18.7 −2.9 −18.4% 14 21.7 23.5 −1.8  −8.3% 15 32.8 36.3 −3.5 −10.7% 16 24.9 28.6 −3.7 −14.9% 17 14.9 16.2 −1.3  −8.7% 18 23.1 24.7 −1.6  −6.9% 19 19.4 26.0 −6.6 −34.0% 20 15.6 19.9 −4.3 −27.6% 21 18.9 21.0 −2.1 −11.1% 22 29.1 32.0 −2.9 −10.0% 23 25.9 27.8 −1.9  −7.3% 24 19.3 22.6 −3.3 −17.1% 25 24.6 25.5 −0.9  −3.7% 26 32.2 32.0 0.2    0.6% 27 11.6 11.6 0.0    0.0% 28 36.9 36.1 0.8    2.2% 29 27.9 28.0 −0.1  −0.4% 30 9.4 15.1 −5.7 −60.6% Averages 22.9 25.3 −2.4 −12.6%

[0318] In 26 of the 29 duplicate samples, the sample obtained utilizing the D-Lead®-D-Wipe® Stick Site Cleansing Protocol gave a lower blood lead value than the standard CDC Stick Site Cleansing Protocol. The reduction ranged from a reduction of 0.1 μg/dL (0.1%) to 5.7 μg/dL (61%) [at a blood lead of 9.4] and 6.6 μg/dL (34%) [at a blood lead of 19.4]. In one individual the result of both samples was identical, and for 2 individuals the CDC protocol gave a lower result, 0.2 μg/dL (−1%) and 0.8 μg/dL (−2%). However, these differences are entirely within the analytical accuracy of the laboratory method, +/−1.0 μg/dL, so the values are considered to be equal.

[0319] Of the 29 duplicate samples, 7 had results within the analytical accuracy of the analysis by GFAAS, +/−1 μg/dL. If we chart the remaining results for the 22 samples that differed by more than the difference of precision of the analysis, we see that the average blood lead level result is 16.2% less with the D-Lead®-D-Wipe® Stick Site Cleansing Protocol. All 22 of these samples were lower when the stick site was prepared with the D-Lead®-D-Wipe® Stick Site Cleansing Protocol. These 22 sample results are listed in Table 8.

TABLE-US-00011 TABLE 8 Blood Lead Results with Differences of more than the Level of Precision Blood Lead μg/dL Test DLDW- CDC- Difference Test Subject #: VP VP μg/dL Subject #: 1 24.5 27.8 −3.3 −13.5% 3 32.0 34.0 −2.0  −6.3% 4 18.1 19.2 −1.1  −6.1% 5 18.9 21.4 −2.5 −13.2% 6 15.7 22.7 −7.0 −44.6% 79 40.4 43.8 −3.4  −8.4% 10 16.2 18.6 −1.8 −14.8% 11 24.7 26.5 −2.4  −7.3% 12 26.7 28.4 −1.7  −6.4% 13 15.8 18.7 −2.9 −18.4% 14 21.7 23.5 −1.8  −8.3% 15 32.8 38.3 −3.5 −10.7% 16 24.9 28.6 −3.7 −14.9% 17 14.9 16.2 −1.3  −8.7% 18 23.1 24.7 −1.6  −6.9% 19 19.4 26.0 −6.6 −34.0% 20 15.6 19.9 −4.3 −27.6% 21 18.9 21.0 −2.1 −11.1% 22 29.1 32.0 −2.9 −10.0% 23 25.9 27.8 −1.9  −7.3% 24 19.3 22.6 −3.3 −17.1% 30 9.4 15.1 −5.7 −60.6% Averages: 22.2 25.2 3.0 −16.2%

[0320] For the 22 samples (81.5% of the individuals) with a difference greater than the analytical accuracy of the analytical method, all showed a reduction in the measured blood lead level by an average 3.0 μg/dL or 16.2%.

Discussion

[0321] The reduction of the blood lead result cannot be explained by suppression or reduced availability of the lead in the blood sample during the analysis, as spiked blood lead tests clearly show this does not occur. The results can only be explained by a reduction in sample contamination of the venous blood sample. The D-Lead®-D-Wipe® Stick Site Cleansing Protocol was significantly better than the CDC protocol at eliminating blood sample contamination from lead on and in the surface of the skin. This reduction in sample contamination was at least 12.6% of the measured value.

Conclusion

[0322] Rigorous blood sample stick site cleaning with highly efficient, contaminant specific skin cleaners provides a method that significantly reduces the amount lead from sources not in the circulating blood stream as compared to the standard stick site protocol recommended for collecting blood lead samples. The data indicates that the D-Lead®-D-Wipe® Stick Site Cleansing Protocol reduces contamination of the sample from the skin during the blood sampling step.

[0323] 6. Analysis and Comparison of the D-Lead®-D-Wipe® Stick Site Cleansing Protocol for Capillary Blood Lead Samples vs. the Centers for Disease Control Stick Site Cleansing Protocol for Capillary Blood Lead Samples

Objective

[0324] The level of accuracy achieved by GFAAS analysis of blood lead specimens collected on filter paper using the D-Lead®-D-Wipe® Stick Site Cleansing Protocol for Capillary Blood Lead Samples was compared with the level of accuracy achieved by whole blood capillary tube specimens analyzed by Inductively Coupled Mass Spectroscopy (ICMS). Then these results were compared with all other types of capillary blood lead specimen collection and analysis, using the current CDC—recommended stick site cleansing and preparation protocol.

Background

[0325] It is generally accepted that the primary cause of falsely elevated capillary blood lead test results (whole blood or dry blood on filter paper) is pro-analytic contamination of the specimen by lead. In an effort to mitigate this threat to the accuracy and reliability of capillary blood lead testing, we investigated the use of the lead and metal removal skin cleaning products disclosed in this patent application in conjunction with capillary blood lead specimen collection.

[0326] In the effort to mitigate the blood sample contamination that has been prevalent (reported in the literature to be as high as 77%) in Capillary Blood Lead Screening Programs, we began working in conjunction with a CLIA licensed laboratory in mid 2004. At this time we began supplying and the laboratory began mandating the use of D-Lead® Deluxe Whole Body Wash and Shampoo and D-Wipe® Towels as part of the specimen collection protocol for collecting capillary blood samples collected with their Filter Paper Quantitative Blood Lead Test. This protocol is referred to as: The D-Lead®/D-Wipe® Capillary Stick Site Cleansing Protocol (DLDW-CP).

[0327] At approximately the same time that the mandated use of the D-Lead®/D-Wipe® Capillary Stick Site Cleansing Protocol was incorporated into the specimen collection protocol, this clinical laboratory was awarded a contract by a State Department of Health to analyze all public health blood lead specimens collected in the state. As a result of this contract, they performed GFAAS analysis of all blood lead specimens collected in Mississippi State's County Department of Health Clinics between Jul. 1, 2004 and Jul. 20, 2005. Specimens were collected by public health nurses on filter paper using the D-Lead®/D-Wipe® Capillary Stick Site Cleansing Protocol. This protocol involved thoroughly washing the stick site with D-Lead® Deluxe Whole Body Wash followed by a thorough rinse, then scrubbing the stick site with a D-Wipe® Towel, and wiping the stick site with an alcohol pad prior to making the stick.

[0328] Early in 2005, the state determined that its own Department of Public Health Laboratory would begin performing blood lead analysis for all specimens effective Jul. 1, 2005. For the period from Jul. 1, 2005 through Feb. 22, 2006 all public health specimens for the same state consisted of whole blood collected in capillary tubes. These specimens were analyzed by the state public health laboratory using Inductively Coupled Mass Spectroscopy. It is reasonable to assume that essentially the same group of public health nurses collected the specimens in 2005/2006 as collected the filter paper specimens in 2004/2005. It is presumed (but not known) that the standard CDC-recommended stick site cleansing and preparation protocol was used prior to the collection of the 2005/2006 whole blood capillary tube specimens. This protocol involves washing the stick site with soap and water and wiping the stick site with an alcohol pad prior to making the stick.

[0329] The Filter Paper blood lead specimens collected between Jul. 1, 2004 and Jul. 20, 2005 using the D-Lead®/D-Wipe® Capillary Stick Site Cleansing Protocol are compared with the whole blood capillary tube specimens collected using the CDC standard stick site cleansing and preparation protocol and analyzed by the state public health laboratory since Jul. 1, 2005 through Feb. 22, 2005.

Sources of Data

[0330] Data for the Filter Paper sample results collected with the D-Lead®/D-Wipe® Capillary Stick Site Cleansing Protocol was drawn from the Laboratory's Medical Database. All of the DLDW-CP data cited is “as reported” to the State Department of Public Health. Data for all other laboratories and for the state public health laboratory was provided by the State Department of Public Health in response to a formal request for public documents. The data requested and provided was for all elevated capillary blood screening test results and the result of any subsequent follow up confirmation test.

Discussion

[0331] In 2004/2005, a total of 14,413 specimens were submitted as capillary blood filter paper samples by the state's 88 testing sites to the contracted laboratory. The testing supplies were supplied by this same laboratory and included the D-Lead® Deluxe Skin Cleaner and D-Wipe® Towels. The written specimen collection procedure incorporated the D-Lead®/D-Wipe® Stick Site Cleansing Protocol. Of the total specimens submitted, 273 specimens (1.89%) were rejected by the laboratory. (Specimens are rejected when there is insufficient blood on the filter paper (‘QNS’-Quantity Not Sufficient), or the specimen does not meet sample quality requirements). The remaining 14,140 specimens were analyzed by GFAAS. This analysis yielded 362 results ≧10 μg/dL (2.56% of total specimens analyzed). Eighty four (84) of these elevated results were eliminated from the study because they were not confirmed by a subsequent venous test. An additional 74 elevated results were eliminated from the study because a confirmatory venous analysis was not performed within 90 days of capillary specimen analysis.

[0332] Of the remaining 204 elevated results, 94 (46.1%) met the defined accuracy criteria, and 110 (53.9%) did not meet the defined accuracy criteria.

[0333] Of the total of 13,982 blood lead test specimens in the study, 13,872 (99.21/%) met the defined accuracy criteria, 110 (0.79%) did not meet the defined accuracy criteria.

[0334] Two significant findings emerged from the data analysis. [0335] 1. Perfect accuracy (100%) was achieved by 41 of the 88 collection sites (46.6% of total). That is to say, 100% of the specimens they submitted met accuracy criteria. These sites submitted 3,763 specimens (26.18% of total). [0336] 2. All 110 samples that did not meet the accuracy criteria were submitted by 57 of the 88 sites. That is to say: Even the 57 sites that submitted one or more inaccurate samples had a high accuracy rating of 98.92%

[0337] Therefore, possible specimen contamination issues were confined to 53.94% of total sites and 73.82% of total specimens submitted. The largest site submitted 619 specimens of which 617 (99.68%) met accuracy criteria. The smallest site submitted 3 specimens, all of which met accuracy criteria.

[0338] Accuracy by site ranged from a high of 100% to a low of 95.24%. The ten largest sites submitted a total of 4,432 specimens, of which 4,391 (99.07%) met accuracy criteria. The ten smallest sites submitted a total of 147 specimens, of which 145 (98.64%) met accuracy criteria. Eight of the ten smallest sites had perfect accuracy records. The 15 sites (193%) with the lowest level of accuracy submitted 1,900 specimens of which 47 were inaccurate. These 15 sites submitted 42.7% of all of the inaccurate specimens

[0339] This suggests variability in the implementation and use of the mandated D-Lead® D-Wipe® Stick Site Cleansing Protocol by different sites.

Results

[0340] Three sets of data have been compared:

[0341] 1. Filter Paper specimens collected by the Mississippi state department of health in 2004/2005 who were supplied with the D-Lead®/D-Wipe® skin cleansing supplies and the D-Lead®/D-Wipe® Capillary Stick Site Cleansing and Prep Protocol and analyzed by GFAAS.

[0342] 2. Whole blood capillary tube specimens collected in 2005/2006 by the same State Department of Public Health (and, presumably, the same collection staff) with other stick site cleansing and prep protocol and analyzed by the state's public health laboratory using Inductively Coupled Mass Spectroscopy (ICMS).

[0343] 3. Specimens from the same state analyzed by all laboratories other than the laboratory listed in item #1 above in 2005/2006 using other stick site cleansing and prep protocol. This group includes all other laboratories who analyzed blood lead samples for public or private health care provider in the state during the year, by all methods, and this set of specimens is assumed to include alternative filter paper, whole blood capillary tube, and LeadCare®. The analysis of the blood lead samples in this set would include all recognized blood lead testing methods, which are analysis by GFAAS, ICMS, ASV and LeadCare® ASV.

[0344] 1. Filter Paper Test with the D-Lead®/D-Wipe® Capillary Stick Site Cleansing Protocol

[0345] Time Period—Jul. 1, 2004 through Jul. 20, 2005-385 days

[0346] Specimen Collection Protocol—Dried blood on filter paper

[0347] Stick Site Cleansing and Prep Protocol—Wash with D-Lead® Deluxe, rinse, dry, wipe with D-Wipe® Towel, wipe with alcohol wipe, stick, collect

[0348] Analysis—GFAAS

TABLE-US-00012 TABLE 9 Summary of Testing with Filter Paper and D-Lead ®/D- Wipe ® Capillary Stick Site Cleansing Protocol Total Filter Paper Specimens Submitted 14,413 Rejected Specimens (.0189) 273 Elevated Results with No Confirmatory Test 84 Elevated Results With ≧ 90-Day Confirmation. 74 Total Filter Paper DLDW-C P Results Studied 13,982

TABLE-US-00013 TABLE 10 Accuracy of Filter Paper Tests using D-Lead ®/D-Wipe ® Capillary Stick Site Cleansing Protocol Number % Total Elevated FP Results With Confirmation ≦ 90 204   100% Days No. of Elevated Results With Confirmatory Venous 94  46.1% Results ≦ Days Meeting Accuracy Criteria No. of Elevated Results With Confirmatory Venous 110  53.9% Results ≦ Days Not Meeting Accuracy Criteria No. of Total Specimens Submitted Meeting Accuracy 13,872 99.21% Criteria No. of Total Specimens Submitted Not Meeting 110  0.79% Accuracy Criteria

[0349] 2. Capillary Tube Test by State Public Health Laboratory Using CDC Capillary Specimen Collection Protocol [0350] Time Period—Jul. 8, 2005 through Feb. 22, 2006-230 days [0351] Specimen Collection—Whole Blood Capillary Tube [0352] Stick Site Cleansing and Prep Protocol—CDC-recommended—wash soap/alcohol wipe/stick/collect [0353] Methodology—ICMS

TABLE-US-00014 TABLE 11 Summary of Testing Capillary Tube Samples with Standard CDC Capillary Stick Site Cleansing Protocol No. of Elevated Capillary Specimens With 44  100% Confirmatory Venous Results ≦ 90 Days No. of Elevated Capillary Specimens With 17 36.8% Confirmatory Venous Results ≦ Days Meeting Accuracy Criteria No. of Elevated Capillary Specimens With 27 61.4% Confirmatory Venous Results ≦ Days Not Meeting Accuracy Criteria

[0354] 3. All Laboratories & Methods using Standard CDC capillary Stick Site Cleansing Protocol [0355] Time Period—Jul. 1, 2005 through Mar. 7, 2006-250 days [0356] Specimen Collection Protocol Alternative FP, Whole Blood Capillary Tube, LeadCare® [0357] Stick Site Cleansing and Prep Protocol—CDC recommended—wash soap/alcohol wipe/stick/collect [0358] Methodology—Undetermined combination of ICMS, GFAAS, ASV, LeadCare® ASV

TABLE-US-00015 TABLE 12 Summary of All Lab Testing Capillary Samples with Standard CDC Capillary Stick Site Cleansing Protocol No. of Elevated Capillary Specimens With 172  100% Confirmatory Venous Results ≦ 90 Days No. of Elevated Capillary Specimens With 71 41.3% Confirmatory Venous Results ≦ 90 Days Meeting Accuracy Criteria No. of Elevated Capillary Specimens With 101 58.7% Confirmatory Venous Results ≦ 90 Days Not Meeting Accuracy Criteria

TABLE-US-00016 TABLE 13 Comparison of elevated Capillary Results Meeting Accuracy Criteria All Filter Paper State Public Health Laboratories & with D-Lead ® / Laboratory with whole Methods using D-Wipe ® blood capillary tube Standard CDC Capillary Stick and Standard CDC Capillary Stick Site Cleansing Capillary Stick Site Site Cleansing Methodology Protocol Cleansing Protocol Protocol % Accurate 46.1 % 38.64 % 41.3% Results

[0359] The Filter Paper & D-Lead®/D-Wipe® Protocol had 19.30% greater accuracy than the State Laboratory with the CDC Protocol.

[0360] The Filter Paper & D-Lead®/D-Wipe® Protocol had 11.63% greater accuracy than all other Laboratories and Methods with the CDC Protocol.

Conclusion

[0361] Given the definition of capillary blood lead testing accuracy, and the large volume of data, including data from comparative filter paper and capillary tube specimens collected by the same individuals:

[0362] 1. Even though the Filter Paper method introduces an additional drying and handling step with the inherent opportunity for additional sample contamination, that, in actual practice, the use of the D-Lead®/D-Wipe® Capillary Stick Site Cleansing Protocol achieved a higher level of accuracy than was obtained with the collection of whole blood capillary tube specimens using other standard stick site cleansing and prep protocols and ICMS analysis.

[0363] 2. That, in actual practice, the use of the D-Lead®/D-Wipe® Capillary Stick Site Cleansing Protocol with analysis by GFAAS provides a higher level of accuracy than can be achieved on a statewide basis, by all alternative forms of capillary blood lead specimen collection and analysis methods using other standard stick site cleansing and prep protocols.

[0364] In addition to the methods discussed previously, the following are additional preferred methods of the present invention.

[0365] For capillary blood samples collected from the finger: If water is available: Wet hands, apply skin cleanser of the liquid type described as Type A, wash, rinse with clean water, then scrub the stick site with the specially formulated wipe described herein, then the alcohol wipe.

[0366] For capillary blood samples collected from the finger: If water is not available: Apply a liquid skin cleanser of the type described as Type B, wash, wipe cleanser off with a cotton or paper towel, then scrub the stick site with the specially formulated wipe described herein, then the alcohol wipe.

[0367] For capillary blood samples collected from the ear lobe, toe or heel, after washing the hands as described above, wash the stick site with the appropriate skin cleanser, then wipe with the premoistened towel, then the alcohol wipe.

[0368] For venous blood samples collected from the forearm: If water is available: Wet hands and arms, apply skin cleanser of the liquid type described as Type A, wash hands and arms to a point above the stick site, rinse with clean water, then repeat by washing the blood sample stick site and rinsing with clean water. Then scrub the stick site with the specially formulated wipe described here, then the alcohol wipe.

[0369] For venous blood samples collected from the forearm: If water is not available: Apply a liquid skin cleanser of the type described as Type B, wash hands and arms to a point above the stick site, wipe cleanser off with a dry cotton or paper towel, then wash the stick site with the Type B skin cleaner and wipe cleaner off with a dry cotton or paper towel, and then scrub the stick site with the specially formulated wipe described here, then the alcohol wipe.

[0370] The skin cleansers and/or premoistened wipe can also incorporate a skin disinfectant to eliminate the alcohol wipe step.

[0371] Various alternatives are contemplated as being within the scope of the following claims particularly pointing out and distinctly claiming the subject matter regarded as the invention.