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Point-of-Care COVID-19 Antibody Test
20 Test Kits

covid-19 rapid antibody test kit
COVID-19 antibody test use instructions
SKU: 8COV19 Category: Tags: , , , ,
(1 customer review)
Point-Of-Care COVID-19 Antibody Test

In stock.  No returns.  Product expiration 9/30/22.

  • CLIA Waived for medical professional use
  • 20 test kits per box
  • Includes test kit, lancets, buffer solution, alcohol wipe pads
  • Test results in :10
  • Detects IgM and IgG antibodies

This product has received their EUA letter from the FDA as a point-of-care test.

$ 145.00

In stock

Description

Point-of-Care COVID-19 Antibody Test

The point-of-care COVID-19 Antibody Test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma.

The COVID-19 IgG/IgM Rapid Test is an essential screening test that enables healthcare professionals to make determinations of patients’ status after contracting COVID-19.  This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should be confirmed with alternative diagnostic testing method(s) and clinical findings.

CLIA Waived for medical professional use.

Product Details

  • Results in 10 minutes
  • Detection window: Symptomatic 5 days, Asymptomatic 7 days
  • Easy to administer: A small finger-prick blood sample
  • Reliable results at a fraction of the cost and time of PCR or ELISA tests
  • Test medium: Whole blood, plasma and serum samples
  • 18 month shelf life from manufacture date

What is the difference between IgM and IgG antibodies?

IgM is the first antibody to be produced in response to any antigen (foreign particle) invasion. While IgG is most abundantly found antibody in the human body, IgM is thelargest immunoglobulin among all.

Simply put, IgM will be the first antibody produced by the body if a virus is present in the body. While IgG is the second antibody produced by the body in response to a virus, it will remain longer and is an indicator that the body has produced some level of immunity. There is no final data that suggests the presence of IgG antibodies will protect against future COVID-19 exposure.

COVID-19 IgG/IgM rapid test Specifications

Test medium Whole blood/serum/plasma
Format Test cassette
Detection Window IgM Symptomatic 3-5 days, Asymptomatic 7 days

Shelf-Life

24 months from date of manufacture

Number of test kits per box

20 test kits

Storage

Room temperature or refrigerated (2-30°C)

Test Type

Qualitative, POC screening test only
Country of Origin China

Time to Results

10 minutes

 

Each COVID-19 rapid antibody testing kit includes:
  • Testing cassette
  • Plastic dropper for collecting serum, plasma, or whole blood specimens
  • Desiccant
  • Buffer solution to activate test results
  • Lancet for finger-stick
  • Alcohol wipe pads

Step-by-Step Instructions:

  1. Testing technician must wear appropriate personal protective gear/equipment during test administration
  2. Allow test cassette, specimen, buffer and/or controls to come to room temperature (15-30°C or 59-86°F) prior to testing.
  3. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
  4. Place the test device on a clean and level surface.
  5. For Serum or Plasma Specimens: With a 5 µL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S).
  6. Immediately add 2 drops (about 80 µL) of buffer solution. Avoid air bubbles.
  7. (Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by pipette capable to deliver 5 µL of volume. For Whole Blood Specimen: Hold the 5 µL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 µL) to the specimen well(S) of the test device, then add 2 drops (about 80 µL) of sample buffer to the buffer well (B) immediately.)
  8. Wait for the colored line(s) to appear. The result should be read in 15 minutes.
  • 20 test kits per box
  • Rapid screening test results ready in 10 minutes
  • Facilitates patient treatment decisions quickly
  • Simple, time-saving procedure
  • Small amount of blood needed only 5 µL of serum/plasma or 10 µL of whole blood specimens
  • All necessary reagents provided & no equipment needed
  • High sensitivity and specificity

Product Insert

COVID-19 Antibody Test Specifications & Clinical Study

FDA EUA letter

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What others are saying

  1. Question

    Jacqueline Marco –

    These tests are approved for use by industries holding a CLIA certificate.

    (0) (0)

    Something wrong with this post? Thanks for letting us know. If you can point us in the right direction...

    • One person found this helpful

      Jennie Lee-Pace –

      Hello Jacqueline.

      These are not CLIA Waived. These screening tests are new to the market. It can take up to a year to get CLIA Waived status. I know that a CLIA Waived test is in the works, but most likely will not be available until later this year.

      (1) (0)

      Something wrong with this post? Thanks for letting us know. If you can point us in the right direction...

  2. Great product

    Michael Arthur (verified owner) –

    Love the product and very easy to use.

    (0) (0)

    Something wrong with this post? Thanks for letting us know. If you can point us in the right direction...

    • Jennie Lee-Pace –

      Glad to hear these tests are serving your customers. Very soon we will have a point of care Covid-19 antigen test.

      (0) (0)

      Something wrong with this post? Thanks for letting us know. If you can point us in the right direction...

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