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SARS-CoV-2 IgM/IgG Antibody Test Kit

SARS-CoV-2 IgM/IgG Antibody Test Kit

Our test kit is a lateral-flow assay which uses colloidal gold SARS-CoV-2 recombinant antigen-antibody complexes to identify IgG/IgM Antibodies in the blood.

To ensure the quality of our diagnostics tests, independent validations are performed with research laboratories and industry partners to ensure that our data is useful for the decision-making of policy-makers, laboratories, and consumers. To test our COVID-19 antibody testing kits,  conducted a multi-site validation study at Yale University and the First Affiliated Hospital of Anhui Medical University. Our independent research data indicates 100% specificity and over 95% sensitivity for patients beyond 14 days since symptom onset. With strong research collaborations, verified diagnostic tools are provided to a global audience.

Product Features:

Our rapid diagnostic test for IgM (acute stage) and IgG (recovery stage) antibodies can help determine previous exposure to SARS-CoV-2, the virus responsible for COVID-19.

  • Results within 15 minutes
  • Dual band results for simple interpretation
  • Multi-variable analysis of immunoglobin IgG & IgM
  • Room temperature storage or refrigerated (2-30°C / 36-86°F)
  • Detection Window (IgM): begins to form 3-5 days post infection
  • Results compared to ELISA:
    • 99% Specificity and 95% Sensitivity
  • Whole blood, Serum or Plasma
  • Do not use beyond labeling on package
COVID-19 Infection Chart
Test Procedure

99% Specificity 95% Sensitivity Specimen: Whole Blood, Serum, Plasma Time to Results: 15 minutes Room temperature storage or refrigerated (2-30°C / 36-86°F) Shelf Life: 24 months from the date of manufacture

ITEM CODE: GCCOV-402a (CE) DESCRIPTION: COVID-19 IgG/IgM Rapid Test FORMAT: Cassette SPECIMEN: Whole Blood/Serum/Plasma UOM: 27 Tests/Kit

This test, ​COVID-19 IgG/IgM Rapid Test has been authorized by FDA under an EUA for use by authorized laboratories. 

This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Positive results may be due to past or present infection with non-SARS-CoV-2 Coronavirus strains, such as Coronavirus HKU1, NL63, OC43, or 229E.

This product, COVID-19 IgG/IgM Rapid Test is intended for professional use and not for home use.

Not for the screening of donated blood.

Can I freeze the device for long-term storage?
The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room temperature before use.

​What is the significance of the various test results?
IgM negative, IgG negative: Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.
IgM positive, IgG positive/negative: Acute or recent infection.
IgM negative, IgG positive: Previous, distant infection.

Available to Healthcare Professionals + Labs

The SARS-CoV-2 IgM+IgG antibody kit is only approved for sale to healthcare professionals and labs with appropriate licenses. Proof of documentation is required by law for purchase and only certain markets that accept CE certification or FDA EUA are approved for sale.

SARS-CoV-2 IgM+IgG Antibody Kit

The SARS-CoV-2 antibody kit is packaged with 25 test cassettes, 25 pipettes and 1 bottle of diluent. The test is manufactured by Biohit Healthcare in China. Lancets are sold separately and can be added to the order at time of purchase.

Study Validation

In a recent study conducted at Yale University, the SARS-CoV-2 IgM + IgG detection specificity was near perfect (97-100%) and sensitivity was 94% for patients who were tested at least two weeks from initial symptom onset.

Producing 1M+ Per Day

Our manufacturing capacity is over 30 million test per month, allowing us to meet nearly any demand. Please send an order request and one of our sales representatives will follow up with more information on price, lead time and documentation required for purchase.

Available to CE + FDA EUA Markets

The SARS-CoV-2 IgM+IgG antibody kit is CE certified and was issued an EUA by the FDA. The test is ONLY for sale to markets and governments with appropriate laboratory or healthcare certification and is NOT currently available for personal use.

 

Delivery Time + Locations

From order placement to delivery we strive to hit 5 business days lead times.

Disclaimers

  • This test has been authorized by FDA under an EUA for use by authorized laboratories.
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/ or diagnosis of COVID-19 under Section 564(b)(1) of the ACT, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • This product is intended for professional use and not for home use.
  • Not for the screening of donated blood.
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