RightSign COVID-19 Antibody Tests - IgG/IgM Rapid Blood - Finger Stick - 20 Per Box

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SKU:
INGM-MC42
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Bulk discount rates

Below are the available bulk discount rates for each individual item when you purchase a certain amount

Buy 20 - 39 and pay only $135.00 each
Buy 40 or above and pay only $115.00 each
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$155.00

Description

RightSign COVID-19 IgG/IgM Rapid Test Cassette

Current Expiration Date: APRIL 2022

What is in each box:
- 20 individually sealed test cassettes
- 20 pipettes
- 1 bottle of buffer solution

Developer: RightSign
Test: COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike

rightsign-covid-19-iggigm-rapid-test-cassette.jpg

Test Facts: 


The RightSignTM COVID-19 IgG/IgM Rapid Test Cassette is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium heparin, potassium EDTA, and sodium citrate), serum or plasma (sodium heparin, potassium EDTA and sodium citrate), and finger stick whole blood. The RightSignTM COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The RightSignTM COVID-19 IgG/IgM Rapid Test Cassette should not be used to diagnose acute SARS-CoV-2 infection. 

Testing of serum, plasma and venous whole blood specimens 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.

Testing of finger stick whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. Testing of finger stick whole blood specimens is authorized for use 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. 

Results are for the detection of SARS CoV-2 antibodies. The IgG and IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. 

The sensitivity of RightSignTM COVID-19 IgG/IgM Rapid Test Cassette early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. 

False positive results for RightSignTM COVID-19 IgG/IgM Rapid Test Cassette may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay. 

The RightSignTM COVID-19 IgG/IgM Rapid Test Cassette is only for use under the Food and Drug Administration’s Emergency Use Authorization.



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