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Healgen COVID-19 IgG/IgM Rapid Test Cassette

ANTIGEN DETECTION. MULTIVARIABLE ANALYSIS.

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device is very quick with a processing time of approximately 10 minutes.

The COVID-19 IgG/IgM his highly portable and does not require comlpex equipment making it ideal for testing nationwide. ​

 

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DESCRIPTIOIN

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) are can be transmitted from between non-human vertebrates to humans.

  • The sensitivity of the IgM test is 87.9% and specificity 100% when compared to RT-PCR.

    The sensitivity of the IgG test is 97.2% during the convalescence period, and specificity is 100%.

- Positive results may be detected in as little as 10 minutes

- 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


FDA Permitted pending EUA Tiger is currently offering Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette which they have validated and are offering serology tests as set forth in Section IV.D while pending FDA EUA Approval.
SPECIFICATION

- Sensitivity: IgG 97.2%; IgM 87.9%

- Specificity: IgG 100%; IgM 100%

- DSpecimen: Whole Blood, Serum, Plasma

- Time to Results: 10 minutes

- Shelf Life: 24 months from the date of manufacture

  • BENEFITS

    - Antigen Detection

    - IgM Detection (Active Infection)

    - IgG Detection (Previous Infection)

    - Tiger Owned Asset

    - Highly Portable

    - Does not require complex equipment

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