Blood Test

SARS-CoV2 (Covid-19)

IgM and IgG Antibody Rapid Test

TESTS USED

Biohit

Healgen

​The selection of which test is best is based on the needs of the customer (diagnostic vs screening), the availability of the test (shipping time, minimum quantity requirements), lab processing time, supply and demand.  We've purposefully negotiated with several labs and distributors so that we will not have to tell customers we are unable to fulfill their request because of the lack of supply of a particular test, shipping time or a specific lab processing time due to high demand. 

The efficacy and quality of our tests is paramount. We only use tests that have been FDA Authorized and EUA (emergency use authorization) certified

 

Specificity: 94-97.5% depending on test

Sensitivity: 96-100% depending on test​​

ADVANTAGES

COVID-19 IgM and IgG Antibody Rapid Test

  • Finger prick test provided by our healthcare professionals

  • Results in 10 minutes

  • $20/test

  • Small minimum order requirements

  • Ship times as little as 3 business days

  • Ideal for school, restaurant, hotel, senior living, auto dealer, or corporate setting

  • Easy to test individuals quickly and/or multiple times or regularly (ex: many companies are choosing to provide weekly testing to employees)

  • Easier to get out in front of an outbreak or get one under control

  • Help prevent the spread by early detecting people with potential exposure to the virus and/or that have the virus, assuring people instead of wondering if they have or have been exposed to the virus

PRINCIPLE

COVID-19 IgM and IgG Antibody Rapid Test

​The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.

Materials Provided

  • Test devices

  • Disposable specimen droppers

  • Buffer

  • Package insert

FEATURES

  • Detection Window (IgM): 3-5 days after incubation 

  • Detection Window (IgG): 1-2 weeks 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 & SIGNIFICANCE

  • Specificity: 94-97.5% depending on test

  • Sensitivity: 96-100% depending on test​​

  • Specimen: Whole Blood, Serum, Plasma

  • Time to Results: 10 minutes

  • Shelf Life: 24 months from the date of manufacture

  • Tests/kit: 25

What is the significance of the various test results?

  • IgM negative, IgG negative: Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.

  • IgM positive, IgG positive/negative: Current or recent infection.

  • IgM negative, IgG positive: Previous, distant infection.

INSTRUCTIONS FOR USE

COVID-19 IgM and IgG Antibody Rapid Test

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.

2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):

a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).

4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

Test Procedure Illustration

ADVISORY

This test has been authorized by FDA under an EUA for use by authorized laboratories. 

This test has not been FDA cleared or approved.

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.

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