Covid-19 Antibody Screen Test

Covid-19 Antibody Screen Test

Regular price
$39.99
Sale price
$39.99
Regular price
Sold out
Unit price
per 

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses - 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) can be transmitted from between non-human vertebrates to humans.

 Features:

  • Detection Window (IgM): 3-5 days after incubation 

  • Dual band results for simple interpretation

  • Multivariable analysis of immunoglobin IgG & IgM

  • Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)

  • Procedural internal control included

  • Buffer included

Specifications

  • Clinical Evaluation

    • Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%

    • Negative  Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%

  • Clinical Agreement with Characterized Samples

    • Sensitivity: IgG 96.7%; IgM 100%; Combined 100%​

    • Specificity: IgG 97.5%; IgM 100%; Combined 97.5%​

  • Specimen: Whole Blood, Serum, Plasma

  • Time to Results: 10 minutes

  • Shelf Life: 24 months from the date of manufacture

 

Ordering Information

  • COVID19 IgG/IgM Rapid Test

  • Whole Blood/Serum/Plasma

  • Minumum Order 25 Tests/ Kit

 FAQs
  • 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.

 

Warning

This test has been authorized by FDA under an EUA for use by authorized laboratories.  This test has not been FDA cleared or approved. 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.  

 

Fact Sheets