COVID-19 IgG/IgM Rapid Test Cassette
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood / Serum / Plasma) – Slid Phase immunochromatographic assay for the rapid, qualitative, and differential detection of IgG and IgM antibodies to 2019 Coronavirus in human Whole Blood / Serum / Plasma.
Device: Lateral Flow Rapid Test
Pack Size: 25 tests
Storage: 2-30ºC
Specimen: (Whole Blood / Serum / Plasma)
Test Results: 10 Minutes (Visual) Positive results > 2 Min
Sensitivity: IgM – 87.9 % (87/99), IgG – 97.2 % (35/36) (Comparison RT-PCR)
Specificity: IgM – 100 % (14/14), IgG – 100 % (14/14) (Comparison RT-PCR)
C.E. Marking
EC Declaration of Conformity In accordance with Directive 98/79/EC
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402a
EC Declaration of Conformity In accordance with Directive 98/79/EC
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402a
NICD (South Africa)
Compliant and approved for intended use and marketing (07 September 2020)
Compliant and approved for intended use and marketing (07 September 2020)
SAHPRA Authorisation (South Africa)
Section 22C(1)(b) of the Medicines Act, to sell the Orient Gene SARS-Cov-2 IgG/IgM Rapid test, lot number: 200328
Section 22C(1)(b) of the Medicines Act, to sell the Orient Gene SARS-Cov-2 IgG/IgM Rapid test, lot number: 200328
