HealGen Rapid Antibody Test Kit EUA by FDA (CLIA Verified Purchases Only; Not for Home Use)

Description

*This product is only available to purchase by licensed physicians, clinics and other authorized professionals and institutions. This product is not for home use. 

**CLIA verification required for all purchases

Please email our Sales Team at [email protected] for pricing and order requirements 

The HEALGEN COVID-19 Antibody Test is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies to SARS-COV-2 virus in human whole blood, serum or plasma. (1) COVID-19 Antibody Test Kit includes • 25 Test Cassettes • 25 Pipettes • 1 Buffer Tube NO LANCETS INCLUDED/NEEDED AS THESE TESTS ARE INTENDED TO BE USED WITH VENOUS WHOLE BLOOD, PLASMA, OR SERUM (NOT FINGER STICK).

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

Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Warning
▪ This test has not been FDA cleared or approved;
▪ 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.