BioTime SARS-CoV-2 IgM/IgG Rapid Qualitative Test
Our BioTime SARS-CoV-2 IgM/IgG Rapid Qualitative Test is a Highly Accurate with good Sensitivity & Specificity.
Product Features:
FDA EUA, CE Declaration of Conformity, MHRA, Register in Russia, Ecuador, Peru, Ukraine, Chile, Brazil, Philippines, Honduras, etc.
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Test Results within 10 minutes
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Whole blood, plasma and serum available
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Low risk of infection for operator
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No equipment needed
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Control set available
Clinical Performance:
Test with whole blood
Sensitivity
Specificity
IgM
68.1% (196/288)
100% (234/234）
IgG
IgG/IgM
96.2% (277/288)
98.7% (231/234)
96.2% (277/288)
98.7% (231/234)
Test with plasma
IgM
IgG
IgG/IgM
67.2% (215/320)
97.0% (457/471)
96.6% (309/320)
97.9% (461/471)
96.6% (309/320)
96.4% (454/471)
Sensitivity
Specificity
Test with serum
Sensitivity
Specificity
IgM
81.8% (157/192)
98.3% (59/60)
IgG
IgG/IgM
67.2% (215/320)
97.0% (457/471)
96.3% (185/192)
95.0% (57/60)
Test Procedure:
Note: Please make sure the kit equilibrate to room temperature before testing.
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Mark the sample number on cartridge
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Drip 1 drop(10-15μL) Serum, plasma or whole blood with dropper and add it into “S” well of cartridge
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Add 3 drops(~100μL) detection buffer into “D” well of cartridge
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Wait 10-15 minutes to get result