Abstract
The present invention relates to a method for the pre-analytical treatment of a blood sample to be analyzed, comprising a suitable sample matrix for said sample and suitably centrifuging said sample. The present invention further relates to an apparatus, characterized in that it comprises suitable components for performing the method according to the present invention. The present invention further relates to the use of said apparatus according to the present invention for the automated pre-analytical treatment of a blood sample to be analyzed according to the present invention.
Claims
1. A method for the pre-analytical treatment of a blood sample to be analyzed, comprising the following steps: a) providing the sample to be analyzed in a suitable container, b) providing a suitable sample matrix for said sample, comprising an anticoagulant selected from K.sub.2EDTA, K.sub.3EDTA and sodium citrate in said container, c) centrifuging said sample of b) at about 2000 to 3400g for about 2 to 10 min; and d) subjecting said sample to analytical testing comprising at least two of i) serology testing, ii) clinical chemistry (CC) testing, iii) nucleic acid testing (NAT); and iv) blood typing.
2. The method according to claim 1, further comprising archiving analytical material of i) and/or iii).
3. The method according to claim 1, wherein said container is labeled with a barcode.
4. The method according to claim 1, wherein said sample has a volume of about 5 to 10 ml.
5. The method according to claim 1, wherein said samples for analytical testing are selected from about 900 ul for serology, about 100 ul for CC, about 2 ml for NAT, and about 200 ul for blood typing.
6. The method according to claim 1, wherein said container is a sample tube, vial, or round bottom tube.
7. The method according to claim 1, wherein said sample matrix is provided as a solution and/or a spray dried composition.
8. The method according to claim 1, wherein said method is performed fully automated.
9. The method according to claim 1, wherein said blood sample to be analyzed is not a serum sample and/or does not comprise heparin.
10. The method according to claim 1, wherein said blood sample to be analyzed is a pooled sample.
11. The method according to claim 1, further comprising an additional centrifugation at about 2000 to 3400g for about 15 to 25 min and a re-testing of serology according to claim 1 d) i), if the sample is initially reactive for said serology.
12. An apparatus, characterized in that it comprises suitable components for performing the method according to claim 1.
13. The apparatus according to claim 12, characterized in that it is suitable for generating the sample matrix, centrifugation, aliquot extraction, serology testing, clinical chemistry testing, nucleic acid extraction including, pooling, PCR preparation, blood typing, and/or raw data analysis.
14. The apparatus according to claim 12, characterized in that all components are designed as an integrated apparatus and are located within a housing.
15. A method for the pre-analytical treatment of a blood sample to be analyzed, comprising the following steps: a) providing the sample to be analyzed in a suitable container, b) providing a suitable sample matrix for said sample, comprising an anticoagulant selected from K.sub.2EDTA, K.sub.3EDTA and sodium citrate in said container, c) centrifuging said sample of b) at about 2000 to 3400g for about 2 to 10 min; and d) subjecting said sample to analytical testing comprising at least two of i) serology testing, ii) clinical chemistry (CC) testing, iii) nucleic acid testing (NAT); and iv) blood typing; wherein said method comprises the use of an apparatus according to claim 12.
16. The method, according to claim 1, wherein, in step c) the sample is centrifuged for about 5 min at 2600g.
17. The method, according to claim 1, comprising, in step d) subjecting said sample to analytical testing comprising i) serology testing, ii) clinical chemistry (CC) testing, iii) nucleic acid testing (NAT); and iv) blood typing.
18. The method, according to claim 4, wherein said sample has a volume of about 9 ml.
19. The method, according to claim 10, wherein 2 to 15 samples are pooled.
20. The method, according to claim 11, wherein the additional centrifugation is carried out for about 20 min at about 2600g.
Description
[0042] FIG. 1 shows a schematic overview of a preferred embodiment of the single tube management system according to the invention.
[0043] For FIGS. 2 to 21, the x-axis represents the centrifugation time (minutes, from 1 (left) to 20 (right) per column) and the y-axis the centrifugation in g (from 1000 (top) 4000 (bottom) in 200g increments). Dark gray boxes=fail; light gray boxes=pass.
[0044] FIG. 2A shows the analysis of NAT testing for HBV for diagnostic sensitivity. FIG. 2B shows the analysis of NAT testing for HBV for diagnostic specificity.
[0045] FIG. 3A shows the analysis of NAT testing for HCV for diagnostic sensitivity. FIG. 3B shows the analysis of NAT testing for HCV for diagnostic specificity.
[0046] FIG. 4A shows the analysis of NAT testing for HIV for diagnostic sensitivity. FIG. 4B shows the analysis of NAT testing for HIV for diagnostic specificity.
[0047] FIG. 5A shows the analysis of serology testing for HBsAg for diagnostic sensitivity. FIG. 5B shows the analysis of serology testing for HBV for diagnostic specificity.
[0048] FIG. 6A shows the analysis of serology testing for anti-HBc for diagnostic sensitivity. FIG. 6B shows the analysis of serology testing for anti-HBc for diagnostic specificity.
[0049] FIG. 7A shows the analysis of serology testing for anti-HCV for diagnostic sensitivity. FIG. 7B shows the analysis of serology testing for anti-HCV for diagnostic specificity.
[0050] FIG. 8A shows the analysis of serology testing for HIV duo for diagnostic sensitivity. FIG. 8B shows the analysis of serology testing for HIV duo for diagnostic specificity.
[0051] FIG. 9 shows the analysis of serology testing for blood grouping.
[0052] FIG. 10 shows the analysis of clinical chemistry testing for IgG.
[0053] FIG. 11 shows the analysis of clinical chemistry testing for total protein.
[0054] FIG. 12A shows the analysis of NAT testing for HBV for diagnostic sensitivity. FIG. 12B shows the analysis of NAT testing for HBV for diagnostic specificity.
[0055] FIG. 13A shows the analysis of NAT testing for HCV for diagnostic sensitivity. FIG. 13B shows the analysis of NAT testing for HCV for diagnostic specificity.
[0056] FIG. 14A shows the analysis of NAT testing for HIV for diagnostic sensitivity. FIG. 14B shows the analysis of NAT testing for HIV for diagnostic specificity.
[0057] FIG. 15A shows the analysis of serology testing for HBsAg for diagnostic sensitivity. FIG. 15B shows the analysis of serology testing for HBV for diagnostic specificity.
[0058] FIG. 16A shows the analysis of serology testing for anti-HBc for diagnostic sensitivity. FIG. 16B shows the analysis of serology testing for anti-HBc for diagnostic specificity.
[0059] FIG. 17A shows the analysis of serology testing for anti-HCV for diagnostic sensitivity. FIG. 17B shows the analysis of serology testing for anti-HCV for diagnostic specificity.
[0060] FIG. 18A shows the analysis of serology testing for HIV duo for diagnostic sensitivity. FIG. 18B shows the analysis of serology testing for HIV duo for diagnostic specificity.
[0061] FIG. 19 shows the analysis of serology testing for blood grouping.
[0062] FIG. 20 shows the analysis of clinical chemistry testing for IgG.
[0063] FIG. 21 shows the analysis of clinical chemistry testing for total protein.
EXAMPLES
[0064] According to the data from an international study by the ISBT, many countries started with an implementation of NAT for HCV. After multiplex assays were available, HIV and HBV tests were added. As presented in the International Forum on NAT testing, the NAT results were 244, 680 for HIV-1, HCV and 1,728 for HBV, respectively, after screening of approx. 300 million blood donors for HIV-1 and HCV and 114 million blood donors for HBV. Current screening NAT robot systems (e.g. Roche Cobas 8800 or Grifols Panther) (Grabarczyk P, Koppelman M, Boland F, et al.: Inclusion of human immunodeficiency virus Type 2 (HIV-2) in a multiplex transcription-mediated amplification assay does not affect detection of HIV-1 and hepatitis B and C virus genotypes: a multicenter performance evaluation study. Transfusion 2015; 55:2246-2255) have implemented different chambers to separate the pre-NAT room, from the NAT room and the post-NAT room. Working with these all-in-one NAT systems needs only trained staff, input of individual samples or mini-pools, reagents and disposable. The special requirements for NAT detection were stopped. The instruments can be placed directly to other screening analyzer for serology or for blood grouping.
[0065] For all categories of blood donor screening (NAT, serology, blood grouping and clinical chemistry) tubes with different sample matrix and different pre-analytical conditions were used. Table 1 shows the current specification for sample tubes and centrifugation conditions per diagnostic group
TABLE-US-00001 TABLE 1 Current pre-analytical conditions Centrifugation Centrifugation Diagnostic group Sample matrix time speed NAT EDTA, Citrate 5 min 2,600 + g Serology Serum 20 min 3,000 + g Blood grouping EDTA 5 min 2,600 + g Clinical chemistry EDAT, Citrate 10 min 3,000 + g
[0066] The object of the present invention is to achieve a compatibility (harmonization) of the sample tube matrix and the pre-analytical conditions (in particular centrifugation time and centrifugation speed) to enable all blood donor screening measurements from one sample tube without a substantial reduction of the diagnostic sensitivity and the diagnostic specificity.
[0067] Material and Methods:
[0068] Sample Tubes
[0069] Greiner Bio One 9 ml EDTA sample tube (455036)
[0070] Greiner Bio One 9 ml Citrate sample tube (455322)
[0071] Centrifugation
[0072] All sample tubes were centrifuged using Hettich Rotixa centrifuges. Centrifugation speed is presented in speedg (g=9.81 m/s.sup.2)
[0073] Nucleic Acid Testing (NAT)
[0074] All NAT tests were performed on the Roche Cobas 8800 instruments with the Roche MPX assay for HBV, HCV and HIV-1.
[0075] Serology Testing
[0076] All serology tests were performed on the Roche Cobas 8000 system on the 801 instrument for the parameter HBsAg, Anti-HBc, Anti-HCV and HIV duo.
[0077] Clinical Chemistry Testing
[0078] All clinical chemistry tests were performed on the Roche Cobas 8000 system on the 501 instrument for the parameter IgG and total protein.
[0079] Blood Grouping Tests
[0080] All blood grouping tests were performed on the Beckman Coulter PK7300 instrument for the parameter A, B, 0, Rhesus and Kell. The following reagents were used in order to analyze the antigens and antibodies.
TABLE-US-00002 TABLE 2 Blood grouping reagents Volume Volume Volume concentrate concentrate concentrate Manu- to 200 ml to 400 ml to 600 ml Reagent Dilution facturer NaCl NaCl NaCl Anti-A 1:320 Biorad 625 l 1250 l 1875 l Anti-A 1:320 Ortho 625 l 1250 l 1875 l Anti-B 1:80 Biorad 2500 l 5000 l 7500 l Anti-B 1:160 Ortho 1250 l 2500 l 3750 l Anti-D 1:80 Biorad 2500 l 5000 l 7500 l mon. Clon Anti-D mon. 1:10 Diagast 20.000 l 40.000 l 60.000 l Anti-D 1:40 Biorad 5000 l 10.000 l 15.000 l mon. Clon Anti-C mon. 1:160 SD-Nostic 1250 l 2500 l 3750 l Anti-C mon. 1:80 Immucor 2500 l 5000 l 7500 l Anti-c mon. 1:160 Immucor 1250 l 2500 l 3750 l Anti-c mon. 1:80 BAG 2500 l 5000 l 7500 l Anti-E mon. 1:80 Biorad 2500 l 5000 l 7500 l Anti-E mon. 1:320 Immucor 625 l 1250 l 1875 l Anti-e mon. 1:160 Biorad 1250 l 2500 l 3750 l Anti-e mon. 1:160 Immucor 1250 l 2500 l 3750 l RH Kontrolle 1:80 Biorad 2500 l 5000 l 7500 l Anti-Kell 1:80 SD-Nostic 2500 l 5000 l 7500 l mon. Anti-Kell 1:20 BAG 10.000 l 20.000 l 30.000 l mon.
[0081] Detection of the Diagnostic Sensitivity for NAT
[0082] WHO standards for HBV (10/264), for HCV (06/102) and for HIV-1 (10/152) were diluted to final concentrations of 10 IU/ml, 50 IU/ml and 100 IU/ml, respectively. The final virus concentration was spiked into whole blood samples. Each concentration was tested for each pre-analytical condition (matrix belong on centrifugation time and centrifugation speed) in replicates of 10. Data were analyzed by the number of positive NAT tests divided with the number of tested samples multiplied by 100. The studies on NAT were regarded as successful, if the diagnostic sensitivity was at least 90%.
[0083] Negative blood donor samples were tested for each pre-analytical condition (matrix belong on centrifugation time and centrifugation speed) in replicates of 100. Data were analyzed by the number of negative NAT tests divided with the number of tested samples multiplied by 100. The studies on NAT were regarded as successful if the diagnostic specificity was at least 95%.
[0084] Detection of the Diagnostic Sensitivity for Serology
[0085] Plasma from positive blood donors for HBsAg, anti-HBc, anti-HCV and anti-HIV-1 were diluted to final concentrations of 10 S/Co, 0.5 S/Co, 10 S/Co and 10 S/Co, respectively. The anti-HBc test was performed as a competitive test, therefore positive samples have a S/Co value below 1.0. The final virus concentration was spiked into whole blood samples. Each concentration was tested for each pre-analytical condition (matrix belong on centrifugation time and centrifugation speed) in replicates of 10. Data were analyzed by the number of positive NAT tests divided with the number of tested samples multiplied by 100. The studies on serology were regarded as successful, if the diagnostic sensitivity was at least 90%.
[0086] Detection of the Diagnostic Specificity for Serology
[0087] Negative blood donor samples were tested for each pre-analytical condition (matrix belong on centrifugation time and centrifugations speed) in replicates of 100. Data were analyzed by the number of negative NAT tests divided with the number of tested samples multiplied by 100. The studies on serology are evaluated as successful if the diagnostic specificity is at least 95%.
[0088] Detection of Blood Groups
[0089] Whole blood donor samples with blood groups listed in table 3 were divided into two parts and tested under the current routine conditions (see table 1) and under different pre-analytical conditions (matrix belong on centrifugation time and centrifugations speed) in replicates of 5. Pre-analytical conditions were accepted, if the blood grouping test results were identical to the routine standard.
TABLE-US-00003 TABLE 3 Blood groups as investigated AB0 Rhesus Kell (K+) Replicates A Neg Neg 5 A Pos Neg 5 A Neg Pos 5 A Pos Pos 5 B Neg Neg 5 B Pos Neg 5 B Neg Pos 5 B Pos Pos 5 AB Neg Neg 5 AB Pos Neg 5 AB Neg Pos 5 AB Pos Pos 5 0 Neg Neg 5 0 Pos Neg 5 0 Neg Pos 5 0 Pos Pos 5
[0090] The studies on blood grouping were regarded as successful if the diagnostic sensitivity comparable with the test results under current routine conditions.
[0091] Detection of IgG and Total Protein
[0092] Whole blood donor samples were divided into two parts and tested under the current routine conditions (see table 1) and under different pre-analytical conditions (matrix belong on centrifugation time and centrifugation speed) in replicates of 10. Pre-analytical conditions could be accepted, if the quantitative data between the routine standard conditions and the new pre-analytical conditions were not significant different (p-value >0.05) by the T-Test.
[0093] Centrifugation Time:
[0094] The different centrifugation times were examined from 1 minute to 20 minutes at intervals of 1 minute each.
[0095] Centrifugation Speed:
[0096] The different centrifugation speeds were examined from 1,000g to 4,000g at intervals of 200g each.
[0097] Results:
[0098] 1. Matrix EDTA Plasma Samples, NAT Detection
[0099] Diagnostic Sensitivity HBV
[0100] FIG. 2A shows the analysis of NAT testing for HBV for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0101] Diagnostic Specificity HBV
[0102] FIG. 2B shows the analysis of NAT testing for HBV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0103] Diagnostic Sensitivity HCV
[0104] FIG. 3A shows the analysis of NAT testing for HCV for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0105] Diagnostic Specificity HCV
[0106] FIG. 3B shows the analysis of NAT testing for HCV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0107] Diagnostic Sensitivity HIV
[0108] FIG. 4A shows the analysis of NAT testing for HIV for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0109] Diagnostic Specificity HIV
[0110] FIG. 4B shows the analysis of NAT testing for HIV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0111] 2. Matrix EDTA Plasma Samples, Serology Detection
[0112] Diagnostic Sensitivity HBsAG
[0113] FIG. 5A shows the analysis of serology testing for HBsAg for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0114] Diagnostic Specificity HBsAg
[0115] FIG. 5B shows the analysis of serology testing for HBV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0116] Diagnostic Sensitivity Anti-HBc
[0117] FIG. 6A shows the analysis of serology testing for anti-HBc for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0118] Diagnostic Specificity Anti-HBc
[0119] FIG. 6B shows the analysis of serology testing for anti-HBc for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0120] Diagnostic Sensitivity Anti-HCV
[0121] FIG. 7A shows the analysis of serology testing for anti-HCV for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0122] Diagnostic Specificity Anti-HCV
[0123] FIG. 7B shows the analysis of serology testing for anti-HCV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were evaluated as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0124] Diagnostic Sensitivity HIV Duo
[0125] FIG. 8A shows the analysis of serology testing for HIV duo for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0126] Diagnostic Specificity HIV Duo
[0127] FIG. 8B shows the analysis of serology testing for HIV duo for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0128] 3. Matrix EDTA Plasma Samples, Blood Grouping Detection
[0129] Blood Grouping
[0130] FIG. 9 shows the analysis of serology testing for blood grouping. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if data were comparable to the blood typing data under the current routine conditions.
[0131] 4. Matrix EDTA Plasma Samples, Clinical Chemistry Detection
[0132] IgG
[0133] FIG. 10 shows the analysis of clinical chemistry testing for IgG. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if data were comparable to the clinical chemistry data under the current routine conditions.
[0134] Total Protein
[0135] FIG. 11 shows the analysis of clinical chemistry testing for total protein. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if data were comparable to the clinical chemistry data under the current routine conditions.
[0136] 5. Matrix Citrate Plasma Samples, NAT Detection
[0137] Diagnostic Sensitivity HBV
[0138] FIG. 12A shows the analysis of NAT testing for HBV for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0139] Diagnostic specificity HBV FIG. 12B shows the analysis of NAT testing for HBV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0140] Diagnostic Sensitivity HCV
[0141] FIG. 13A shows the analysis of NAT testing for HCV for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0142] Diagnostic Specificity HCV
[0143] FIG. 13B shows the analysis of NAT testing for HCV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0144] Diagnostic Sensitivity HIV
[0145] FIG. 14A shows the analysis of NAT testing for HIV for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0146] Diagnostic Specificity HIV
[0147] FIG. 14B shows the analysis of NAT testing for HIV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0148] 6. Matrix Citrate Plasma Samples, Serology Detection
[0149] Diagnostic Sensitivity HBsAG
[0150] FIG. 15A shows the analysis of serology testing for HBsAg for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0151] Diagnostic Specificity HBsAg
[0152] FIG. 15B shows the analysis of serology testing for HBV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0153] Diagnostic Sensitivity Anti-HBc
[0154] FIG. 16A shows the analysis of serology testing for anti-HBc for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0155] Diagnostic Specificity Anti-HBc
[0156] FIG. 16B shows the analysis of serology testing for anti-HBc for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0157] Diagnostic Sensitivity Anti-HCV
[0158] FIG. 17A shows the analysis of serology testing for anti-HCV for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0159] Diagnostic Specificity Anti-HCV
[0160] FIG. 17B shows the analysis of serology testing for anti-HCV for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0161] Diagnostic Sensitivity HIV Duo
[0162] FIG. 18A shows the analysis of serology testing for HIV duo for diagnostic sensitivity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 9/10 (90%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 9/10 (90%) tests achieved a positive test result.
[0163] Diagnostic Specificity HIV Duo
[0164] FIG. 18B shows the analysis of serology testing for HIV duo for diagnostic specificity. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if at least 95/100 (95%) tests achieved a positive test result. The pre-analytical conditions were regarded as not successful if less than 95/100 (95%) tests achieved a positive test result.
[0165] 7. Matrix Citrate Plasma Samples, Blood Grouping Detection
[0166] FIG. 19 shows the analysis of serology testing for blood grouping. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if data were comparable to the blood typing data under the current routine conditions.
[0167] 8. Matrix Citrate Plasma Samples, Clinical Chemistry Detection
[0168] IgG
[0169] FIG. 20 shows the analysis of clinical chemistry testing for IgG. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if data were comparable to the clinical chemistry data under the current routine conditions.
[0170] Total Protein
[0171] FIG. 21 shows the analysis of clinical chemistry testing for total protein. The x-axis represents the centrifugation time (minutes) and the y-axis the centrifugation speed. The pre-analytical conditions were regarded as successful (pass) if data were comparable to the clinical chemistry data under the current routine conditions.
