This COVID-19 IgG/lgM Rapid Test 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 EDTA), serum, plasma (sodium EDTA) and fingerstlck whole blood. The Assure COVID- 19 IgG/19M Rapid Test Device 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 mfection and if the presence of antibodies confers protective Immunity The Assure COVID- 19 IgG/lgM Rapid Test Device should not be used to diagnose acute SARS-CoV-2 infection. 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_SC. 263a, that meet requirements to perform moderate or high complexity tests.

This test 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.

Rapid Covid-19 Antibody Test Kit

Blood Pipette

Silver Sterile Packet

Individual Buffer Solution

2 Antibody Detection Test Cassette

All Sales are Final

$599.95

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible

2. Add the specimens
For Venous Whole Blood Specimens, Serum Or Plasma Specimens
a) Using the provided disposable pipette, draw the specimen above the fill line (avoid the specimen entering the bubble Of disposable pipette)
b) Transfer one drop of the specimen into the specimen well of the test device, then add 2 drops of buffer and start the timer Adding more or less drops of specimen may lead to incorrect results Adding 1 drop of butler or more than 4 drops of buffer may lead to incorrect results.

For Fingerstick Whole Blood
a) Clean the puncture site with the alcohol prep pad provided,
b) Carefully remove the cap from the safety lancet. Push the safety lancet firmly against the puncture site until it pricks the finger.
c) Using the provided disposable pipette, draw the specimen above the fill line(avoid the specimen entering the bubble Of disposable pipette)
d) Transfer one drop (equivalent to 10uL) of the specimen into the specimen well of the test device, then add 2 drops of buffer and start the timer Adding more or less drops of specimen may lead to incorrect results Adding 1 drop of buffer or more than 4 drops of buffer may lead to incorrect results.

Wait for the blue line change to red line,read results at 15 minutes.D0 not read results earlier than 15 minutes or
alter 30 minutes.

Rapid Covid-19 Antibody Test Kit

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Description

Coronavirus (SARS-CoV-2) IgM/IgG – Rapid Test Cassette
(Whole Blood/Serum/Plasma)

    • 20 tests per box
    • FDA Emergency Use Authorization (EUA)
    • CLIA waiver for Point of Care Use
    • CE Declaration – Cleared for use in the European Union
    • Pharmacy/Pharmacist use authorized by the HHS
    • 24-month shelf life from date of manufacture
    • Easy to use, results in minutes

Additional information

Weight 13.5 oz
Dimensions 8 × 6 × 4 in
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Rapid Connect Medical
Product Disclaimer

The statements on this website have not been evaluated by the United States Food and Drug Administration (“FDA”). Rapid Connect Medical, LLC’s (the “Company’s” or “our”) test kits and biotechnology goods (collectively, the “Products”) are not intended to diagnose, treat, cure, or prevent any disease. The information contained on this website is intended for informational purposes only. It is not intended to be a substitute for informed medical advice or care. Consult with a licensed medical practitioner before using any of our Products. Use of our Products should be supervised and monitored by a licensed medical professional. Discontinue testing or use immediately if any adverse effects occur and contact a licensed medical professional. Our Products are used at the consumer’s (the “Purchaser’s” or “your”) own risk. All information on this website and associated media, including but not limited to medical reactions or interactions, is supplied to the best of our abilities, but is not guaranteed to be correct and is not intended to supplement the advice of a licensed medical professional. Purchasers take all responsibility to inform themselves before using any of our Products.

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