Biolidics Antibody Kit 2019-nCoV IgG/IgM (Colloidal Gold)

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SKU-GD1C11S1K4

2019-nCoV IgG/IgM

Detection Kit (Colloidal Gold)

FAST

Rapid-results in 10 minutes, including symptomatic and asymptomatic recent or prior infections

COMPLEMENTARY

Complements tests such as PCR¹, used in detecting recent or prior infections

INFORMATIVE

Validated with venous whole blood / serum / plasma² Simultaneous evaluation of IgM and IgG antibodies to SARS-CoV-2

APPROVALS

Fig. 1: Representative IgG and IgM antibody response to a viral infection overtime 3

  • Following a viral infection, IgM antibodies rise first, followed by IgG antibodies, that can last for weeks and more after an infection. The Biolidics’ test detects presence of IgM and IgG antibodies to SARSCoV-2.
  • Positive result: IgG+ and/or IgM+ test lines indicate a recent or prior SARS-CoV-2 infection.
  • Negative result: IgG- and IgM- test lines indicate antibodies to SARSCoV-2 were not detect.*

*IgG/IgM antibodies for SARS-CoV-2 was undetected or antibody levels below limit of detection. The results from this test should not be used as the sole basis to diagnose, exclude SARS-CoV-2 infection and/or to inform infection status. The results will have to be interpreted together with clinical presentation and are to be confirmed with supplemental testing (e.g. RT-PCR).

Performance

Sensitivity

91.54%

(95% CI: 86.87% - 94.65%)

Specificity

97.02%

(95% CI: 94.74 % - 98.33%)

Conformity

95.09%

(95% CI: 92.99% - 96.58%)

Test Interpretation

Results * Interpretation**
IgM positive, IgG positive Suspected recent infection of SARS-CoV-2
IgM positive, IgG negative Suspected recent infection of SARS-CoV-2
IgM negative, IgG positive Patient suspected to have past infection (non-conclusive)
IgM negative, IgG negative Antibody for SARS-CoV-2 Virus undetected OR low IgG/IgM level below limit of detection

SPECIFICATIONS

  • Test time:L 10 MIN
  • Storage: 4°C - 30°C
  • Sample Type: Venous whole blood / Serum / Plasma
  • Format: Cassette

Material Provided

Shipping Cost Shipping Included
Shipping Time Ready to ship in 8-15 Business Days