Instant, COVID-19 "Coronavirus" Test - Rapid On-Site, 2-5 min

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  • Product Type: healthtesting
  • Sellpartner®: Cbio
  • Listing ID: 4411498823738
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$ 1,295.00
$ 995.00

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Product Details

COVID-19 IgG/IgM Rapid Test Cassette

The test is conducted by taking a small finger-prick blood sample, placing it in the center well of the cassette and then adding two drops of the buffer to the buffer well labeled “B.” Results should appear in 3 minutes and are invalid after 10 minutes. 

 

"PREORDER"  ESTIMATED SHIPPING DATE: 04/06/2020

urgent notes: Due to urgent processing, payment is required to secure preorder. In addition, in order to meet urgent supply timelines, this will arrive in bulk packaging (bag containing individually sealed foil-pouched test cassettes, lancets, flattened box, and product insert instructions)

 

Benefits:

  • Rapid results in 2-5 minutes
  • Small sample sizes
  • Sold in packs of 100
  • Lancets included!
  • Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days
  • Shelf life of 24 months from manufacture date
  • Emergency Use/Professional Use Only (not clia waived) 
  • Tests should be conducted by a licensed phlebotomist, or a medical professional -- see FDA guidance here: https://www.fda.gov/media/135659/download
  • Under Section C:
  • The policy described in this subsection applies to commercial manufacturers that seek to develop and distribute diagnostic test kits to detect the SARS-CoV-2 virus to clinical laboratories or to healthcare workers for point-of-care testing. This policy does not apply to at home testing.
Verification of use case prior to shipping is mandatory

 

Limitations:

  • The positive agreement was 93.87% (95%CI:90.24%~96.46%)
  • The negative agreement was 99.10% (95%CI:97.70%~99.75%)
  • Total agreement was 97.19% (95%CI:95.65%~98.26%).
  • The kappa value of the consistency analysis was 0.94 (95%CI:95.65%~98.26%). The results of the clinical evaluation show that the two reagents (methods) have a high degree of consistency and equivalent sensitivity and specificity in detecting COVID-19.
  • Warning: The test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

 

Testing Procedure:

  1. 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.
  2. Place the test device on a clean and level surface.
  3. Prep the patient for finger-puncture, using an alcohol wipe
  4. (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. Avoid air bubbles.
  5. Wait for the colored line(s) to appear. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.


Reading Results:

Negative:

If only the C band is present, the absence of any burgundy color in the both T bands (IgG and IgM) indicates that no anti-COVID-19 antibodies are detected in the specimen. The result is negative.

IgM Positive:

In addition to the presence of C band, if only IgM band is developed, the test indicates for the presence of IgM anti-COVID-19 in the specimen. The result is IgM anti-COVID-19 positive.

-or- IgG Positive:

In addition to the presence of C band, if only IgG band is developed, the test indicates for the presence of IgG anti-COVID-19 in the specimen. The result is IgG anti-COVID-19 positive.

-or- Both IgG and IgM Positive:

In addition to the presence of C band, both IgG and IgM bands are developed, the test indicates for the presence of both IgG and IgM anti-COVID-19 in the specimen. The result is IgG and IgM anti-COVID-19 positive.

Invalid:

Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

More detailed results of ongoing clinical evaluations and test stability report are available upon request.


 

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