SARS_CoV-2 Detection Kits | qRT-PCR Covid-19 Detection Kits | Genomicss

Bio Time IVD POCT

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:

  • Test Results within 10 minutes
  • Whole blood, plasma and serum available
  • Low risk of infection for operator
  • No equipment needed
  • Control set available

FDA EUA, CE Declaration of Conformity, MHRA, Register in Russia, Ecuador, Peru, Ukraine, Chile, Brazil, Philippines, Honduras, etc.

Clinical Performance:

Test with whole blood

Sensitivity
Specificity

IgM

68.1% (196/288)
100% (234/234)

IgG

96.2% (277/288)
98.7% (231/234)

IgG/IgM

96.2% (277/288)
98.7% (231/234)

Test with plasma

Sensitivity
Specificity

IgM

67.2% (215/320)
97.0% (457/471)

IgG

96.6% (309/320)
97.9% (461/471)

IgG/IgM

96.6% (309/320)
96.4% (454/471)

Test with serum

Sensitivity
Specificity

IgM

81.8% (157/192)
98.3% (59/60)

IgG

85.8% (184/192)
95.0% (57/60)

IgG/IgM

96.3% (185/192)
95.0% (57/60)

Test Procedure:

Note: Please make sure the kit equilibrate to room temperature before testing.

  1. Mark the sample number on cartridge
  2. Drip 1 drop(10-15μL) Serum, plasma or whole blood with dropper and add it into “S” well of cartridge
  3. Add 3 drops(~100μL) detection buffer into “D” well of cartridge
  4. Wait 10-15 minutes to get result
Bio Time Test Procedure
Distributors
Kumar & Ballal Exim Private Limited
Ganesh Mahal Complex
K S Rao Road
Mangalore-1
Karnataka, INDIA
 
For South East Asia & India distribution, please contact

Chetan Ravnikar
Vice President