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The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malain Test. It is designed for routine external quality control with the qualitative BinaxNOV® Malaina Test. It is designed for routi proper of the qualitative BinaxNOW "Malana" rest. It is designed for routine use to aid in wisition Test.

The BinaxNOW® Malaria Positive Control is a recombinant antigen control containing a mixture of HRP II (histidine-rich protein II), which is specific for Plasmodium falciparum (P.f.), and a pan-malarial antigen (aldolase), which is common to P.f., P. vivax, P. ovale, and P. malariae. The BinaxNOW® Malaria Positive Control can be used as a quality control sample representative of a positive test result and to verify proper performance of the procedure and reagents of the BinaxNOW® Malaria test, when it is used in accordance with the BinaxNOW® Malaria test product insert. The BinaxNOW® Malaria Positive Control is supplied lyophilized and is reconstituted using deionized water. The reconstituted control is then added to a pool of presumed negative EDTA human whole blood for use in the BinaxNOW® Malaria Test. When run on the BinaxNOW® Malaria Test, the positive control should always generate positive results on both the P.f.specific (HRP II) test line and on the pan malarial test line. This demonstrates that the test reagents are working properly and the operator performed the test procedure correctly.

Abbott STREP A Controls are qualitative control materials intended for use in test systems to monitor substantial reagent failure and procedural errors. Specifically, Abbott STREP A Controls are intended for use as external controls in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptococcal antigen.

The Abbott STREP A Controls, K965252 is the same as Abbott STREP A Controls, K922490. The controls are intended for use as external controls to monitor substantial reagent failure and procedural errors in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptoccal antigen.

The ChlamydiaTrol™ Ag is intended for use as an unassayed control reagent with in vitro diagnostic assay procedures for detection of Chlamydia trachomatis, including both chlamydial antigen (MOMP or LPS) and nucleic acid based methods of detection. ChlamydiaTrol Aq reagents are intended to provide a means of estimating precision and reproducibility, and have the potential for detecting systematic deviations from specific laboratory testing procedures. Use of ChlamydiaTrol Ag reagent will monitor assay functionality and not analytical sensitivity of the assay detection limits.

ChlamydiaTrol Ag is a liquid quality control reagent classified under Multi Analyte Controls(assayed and unassayed). ChlamydiaTrol Ag reagent is prepared from Chlamydia trachomatis elementary bodies extracted from infected mouse L cells grown in culture. Optimally infected cells are harvested and disrupted by sonication, and cellular debris is removed by centrifugation. Chlamydia trachomatis elementary bodies used in the preparation of ChlamydiaTrol Ag reagent have been rendered noninfectious by treatment with gamma radiation. The reagent contains human serum albumin(HSA), preservatives and stabilizers.