Catalogue FINABRIDGE

Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)

For the qualitative detection of the antibodies of IgM/IgG against novel coronavirus in serum, plasma or whole blood from patients with clinical suspicion of COVID-19 infection. The antibody test kit is a product of the human immune response after infection with virus. In general, IgM antibodies appear early in the infection and IgG antibodies appear in middle and late stages on infection. Titers have a continuous increasing process and stay in blood circulation for longer time. The test for specific antibodies can determine whether a patient has “ recently or previously infected 2019-nCoV”.It helps to avoid “ False Negatives” to complementary to nucleic acid test. In the past 2020 LYHER® Novel Coronavirus(2019-nCov) IgM/IgG Antibody Combo Test Kit have been popular in more than 40 countries all over the world and passed a series of the certifications like EU CE, US FDA EUA, WHO EUL,French Ministry of Health, Malta MCCAA, Australia TGA, the Philippines FDA, Thai FDA, Brazil ANVISA and registered in Bolivia, Peru, Chile etc.

Product Features

CE Marked

Result in 10mins

Easy to collect samples

No equipment needed

Easy to read results

Room temperature storage

Clinical trials: Sensitivity: 96.37%, Specificity: 99.05%, Total coincidence rate: 97.88%(Kappa=0.957,P < 0.001)

FDA EUA NCI Serology Test Evaluation repor

Measure

Estimate

Confidence Interval

IgM Sensitivity IgM Specificity IgG Sensitivity IgG Specificity

96.7% (29/30) 100% (80/80) 100% (30/30) 98.8% (79/80) 100% (30/30) 98.8% (79/80)

(83.3%; 99.4%) (95.4%; 100%) (88.7%; 100%) (93.3%; 99.8%) (88.7%; 100%) (93.3%; 99.8%) (40.9%; 96%)

Combined Sensitivity Combined Specificity

Combined PPV for prevalence = 5% Combined NPV for prevalence = 5%

80.8%

100% (99.4%; 100%)

(99.4%; 100%)

Cross-reactivity with HIV+

0.0% (0/10) not detected

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