The invention relates to a system is provided that comprises a lysis chamber, an amplification chamber and a fluorescence detection device. The fluorescence detection device (16) comprises - a detection chamber (42) configured to receive the amplification chamber (14) or the contents of the amplification chamber, - a light source (44), - an optical sensor (46), - energy supply means (48), - a wireless data interface (52) and - a controller (50).

The present invention relates to sample-to-answer systems, devices, cartridges, and method of using the same for detecting the presence of microorganisms in a sample, such as bacteria.

Disclosed in one aspect is a method for performing a complete blood count (CBC) on a sample of whole blood by metering a predetermined amount of the whole blood and mixing it with a predetermined amount of diluent and stain and transferring a portion thereof to an imaging chamber of fixed dimensions and utilizing an automated microscope with digital camera and cell counting and recognition software to count every white blood cell and red blood corpuscle and platelet in the sample diluent/stain mixture to determine the number of red cells, white cells, and platelets per unit volume, and analyzing the white cells with cell recognition software to classify them.

A capillary chamber for performing chemical and physical analysis using a plurality of whole blood samples is presented. Following a loading of the whole blood samples into a plastic tube, the whole blood samples are distributed into a collection chamber and the capillary chamber has means of adding respective vaccines or similar biological products into each capillary tubes. The whole blood is then analyzed using standard microscopic techniques with sufficient resolution and contrast to record the chemical and physical properties of the blood immediately after withdrawal.

A sample collection system can include a sample collection vessel having a sample collection chamber with an opening configured to receive a sample into the sample collection chamber. The sample collection system can additionally include a selectively movable sleeve valve configured to associate with the opening of the sample collection chamber. The sample collection system can include a sealing cap that is configured to associate with the selectively movable sleeve valve and with the sample collection vessel. The sealing cap can include a reagent chamber having reagent(s) stored therein, and when the sealing cap is associated with the sample collection vessel, the selectively movable sleeve valve opens, dispensing the reagent(s) into the sample collection chamber. When the selectively moveable sleeve associates with the sample collection chamber, an outer sleeve slides relative to an inner vessel, opening the sleeve and dispensing reagent into the sample collection chamber.

A diagnostic cartridge and method of performing a diagnostic test are provided. The cartridge includes a body having a sample chamber for receipt of a sample, an analysis chamber, and a reagent-containing dispensing member. A valve member is coupled to the body for selective movement between first and second states. The valve member has a fluid passage with a hydroscopic, gas permeable vent. In the first state, the fluid passage is out of fluid communication with the sample chamber and is registered for fluid communication with the reagent-containing dispensing member. The vent prevents fluid from passing therethrough and allows air to vent therefrom as reagent flows into and fills the fluid passage. In the second state, the fluid passage remains in fluid communication with the reagent-containing dispensing member and is brought into fluid communication with the sample chamber to facilitate transporting the sample to the analysis chamber.

A container of the present invention is for producing or housing a freeze-dried material. The container includes a bottom wall, a side wall, a support part for supporting a fluid to be freeze-dried in such a way that the fluid does not contact the bottom wall; and at least one vent disposed in the bottom wall or in at least a portion of the side wall located below the top of the support part.

Infectious diseases have been sources of large-scale epidemics and pandemics resulting in millions of casualties worldwide. Detection of these biological agents normally involves several lab processes including sample preparation, nucleic acid separation and amplification, and diagnostic analysis. These steps, either performed manually or automated by high-throughput machinery, are tedious, expensive, and highly susceptible to cross-contamination. The present system is an integrated lab-on-a-device designed, developed, and tested in compatibility with a mechanical fixture for sample-to-answer biological analysis of infectious diseases.

A cartridge for providing a target analyte for detection is described. One such exemplar cartridge includes a base portion including: (1) a receiving area disposed at or near a center region of the base portion; (2) multiple reaction wells disposed outside the center region or radially disposed at or near a perimeter of the base portion; and (3) multiple connecting tracks that substantially linearly extend from a region at or proximate to the receiving area to the multiple reaction wells and designed to convey a sample including the target analyte from the receiving area to the multiple reaction wells, each of which are configured to transform the sample to a detectable sample. Systems and methods of reacting and detecting the sample including the target analyte are also described.

A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.