Introduction

The KaiBiLi^TM COVID-19 IgG/IgM Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019- Novel Coronavirus in human whole blood, serum or plasma specimen. It is only used as a supplementary detection indicator for new suspected cases of negative coronavirus nucleic acid detection or in conjunction with nucleic acid detection in the diagnosis of suspected cases. It cannot be used as a basis for the diagnosis and exclusion of pneumonitis infected by 2019-nCoV infection. It is not suitable for general population screening.

Any reactive specimen with the COVID-19 IgG/IgM Rapid Test Device must be confirmed with alternative testing method(s) and clinical findings. A positive test result requires further confirmation. A negative results do not preclude acute 2019-nCoV infection. If acute infection is suspected, direct testing for COVID-19 antigen is necessary. False positive results for COVID-19 IgG/IgM Rapid Test may occur due to cross-reactivity from preexisting antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.

Detection

The COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative lateral flow immunechromatographic assay for the detection of IgG and IgM antibodies to 2019-nCoV in whole blood, serum or plasma specimen.

Specimen

The test uses anti-human IgM antibody (test line IgM), anti-human IgG (test line IgG) and goat anti-rabbit IgG (control line C) immobilized on a nitrocellulose strip.

Accuracy

IgG Result:

Relative Sensitivity: 98.28%

Relative Specificity: 97.01%

Accuracy: 97.40%

IgM Result:

Relative Sensitivity: 82.76%

Relative Specificity: 98.51%

Accuracy: 93.75%

Time to Results

Read results at 15minutes and no more than 30 minutes.

Kit storage conditions

2~30°C.

Contents

Ordering Information