COVID-19 RAPID TEST KIT

INTENDED USE

The COVID-19 IgM/IgG Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgM and IgG antibodies to COVID-19 in human whole blood, serum or plasma specimens. 

REAGENTS

The test contains anti-human IgM and anti-human IgG as the capture reagent, COVID-19 antigen as the detection reagent. A goat anti-chicken IgY is employed in the control line system.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity
The COVID-19 IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with a leading commercial PCR; the results show that the test has a high sensitivity (99.4%, 162/163) and specificity (100%, 153/153).

Cross-reactivity
The COVID-19 IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested for anti- influenzaAvirus,anti-influenzaBvirus,anti-RSV,anti-Adenovirus,HBsAg,anti-Syphilis,anti-H.Pylori, anti-HIV and anti-HCV positive specimens. The results showed no cross-reactivity.

Interfering Substances
The following compounds have been tested using the COVID-19 IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) and no interference was observed.

  • Triglyceride: 50 mg/dL
  • Ascorbic Acid: 20 mg/dL
  • Hemoglobin 1000 mg/dL Bilirubin: 60 mg/dL
  • Total cholesterol : 6 mmol/L

DIRECTIONS FOR USE

 

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