Description
MSDS-Clarity-hCG-Combo-Cassette-DTG-COMBO-2
Clarity hCG Single Step Combo Urine/Serum Pregnancy Test Kit 50/box 10/20 Cassette
The Clarity hCG Rapid Combo10 Test Device (Urine/Serum) is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.
• Contains: hCG Urine/Serum Test Cassettes and Package Insert.
• Sensitivity: 20 mlU/ml.
• Specificity: 100% – No cross reaction with FSH/TSH/LH.
• 99% Overall Accuracy.
• Can be used with urine or serum.
• 24 Month Dating.
• CLIA Waived for Urine Samples.
• CLIA Moderate for Serum Samples
The Clarity hCG Rapid Combo Test Device (Urine/Serum) detects human chorionic gonadotropin through visual interpretation of color development in the internal strip. Anti-hCG antibodies are immobilized on the test region of
the membrane, and anti-mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti-hCG antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient hCG in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred
