INFECTIOUS DISEASE TESTS
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DESCRIPTION: Smart Check™ HIV Test is a single rapid reagent assay for the detection of antibodies to human immunodeficiency virus types 1 and 2 in serum, plasma or whole blood.
SENSIVITY/SPECIFICITY: Sensitivity - 99.6%, Specificity – 99.9%. Quantitative sensitivity - Panel results of 1:80 is within the range of the average rapid assays assessed at the N/V (1:40-1:160).
PRODUCTS
Infectious Disease Tests
Tropical Disease Tests
Sexually Transmitted
Disease Tests
Womens Health
TEST FORMAT:Device SAMPLE: Whole Blood/Serum
Gastrointestinal Tests
Cardiac Marker Tests TIME TO RESULT: 5-15 minutes EXPORT STATUS: FDA 802(g)
Cancer Markers LIST PRICE: $1.22 DISCOUNTS: See Shopping Cart
Drug Abuse Tests
Urine Chemistry Tests
Miscellaneous Tests
HEPATITIS C (HCV)
DESCRIPTION: Smart Check™ Anti-HCV Test is a rapid direct binding test for visual detection of hepatitis C antibodies (Anti-HCV) in whole blood/serum as an aid in the diagnosis of hepatitis C infection. Based on the principle of double antigen sandwich immunoassay for determination of Anti-HCV in serum.
SENSIVITY/SPECIFICITY: Sensitivity - 98.9%, Specificity - 99.2%. All samples detected as positive by the ELISA assay were detected by the Smart Check™ Anti-HCV as positive. 		 
TEST FORMAT:Device SAMPLE: Whole Blood/Serum
TIME TO RESULT:10-20 minutes EXPORT STATUS: FDA 802(g)
 
LIST PRICE: $1.52 DISCOUNTS: See Shopping Cart
HEPATITIS B (HbsAg)
DESCRIPTION: Smart Check™ HBsAg Test is a rapid direct binding test for visual detection of hepatitis B surface antigen (HBsAg) in whole blood/serum as an aid in the diagnosis of hepatitis B infection. The Smart Check HBsAg Test is based on the principle of double antigen sandwich immunoassay for determination of HBsAg in serum.
SENSIVITY/SPECIFICITY:Sensitivity - 99.2%, Specificity - 99.8%. All samples detected as positive by the ELISA assay were detected by the Smart Check HBsAg as positive
TEST FORMAT:Device SAMPLE:Whole Blood/Serum
TIME TO RESULT:10-20 minutes EXPORT STATUS: FDA 802(g)
LIST PRICE: $1.22 DISCOUNTS: See Shopping Cart
 
TUBERCULOSIS (TB)
DESCRIPTION: Smart Strip™ TB Test is an in vitro, IgM/IgG qualitative immuno-chromatographic assay for the rapid detection of Mycobacterium tuberculosis infection in whole blood, serum or plasma. The test utilizes an indirect solid-phase antigen immunoassay technology for the qualitative detection of M. tuberculosis antibodies.
SENSIVITY/SPECIFICITY:Sensitivity - 96.7%, Specificity - 82.1%
TEST FORMAT:Device SAMPLE: Whole Blood/Serum
TIME TO RESULT:15 minutes EXPORT STATUS: FDA COE 801(e)
LIST PRICE: $2.82 DISCOUNTS: See Shopping Cart
 
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