COVID-19 IgG/IgM Rapid Antibody Blood Test, Min. Order 100 Test Cassettes

COVID-19 IgG/IgM Rapid Antibody Blood Test, Min. Order 100 Test Cassettes

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SKU:
CBI-GCCOV-402A
Weight:
0.01 LBS
Shipping:
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Minimum Purchase:
1 unit

info@stellarscientific.com for order instructions

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Our rapid antibody (serology) test from Healgen LLC looks for both the IgM and IgG antibodies in a single, rapid blood test.

The presence of IgM indicates the patient is currently battling SARS-CoV-2 while the presence of IgG indicates the patient is in recovery from Coronavirus. The test is conducted by taking a small 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.

Patients taking our antibody test were also tested with RT-PCR for validation. 

The sensitivity for detection of IgM was 87.9% with a specificity of 100%, while the detection of IgG was 97.2% with a specificity of 100%

Our antibody tests are available for sale to hospitals, clinics, medical centers and employers who will use the services of a licensed facility to perform their testing.

Our serology antibody tests have been granted FDA EUA authorization May 29th 2020

Please note: ALL SALES ARE FINAL - PRODUCT MAY NOT BE RETURNED

Antibody tests like ours have been used recently in Santa Clara, Los Angeles and New York City to develop a better picture of how the virus has spread. 

If you are curious about how antibody tests work and how they will help us get back to normal, here are a few valuable articles. 

Article from 4-2-2020 about the need for antibody tests: 

Article from 4-28-2020 about what antibody tests tell us about the scope of Coronavirus:

Also read our blog posts from April 3rd, April 5th and April 13th where we explain the protocol and what makes our tests different. 

Features and requirements:

  • Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days
  • Sample: Test can work with whole blood, plasma and serum samples.
  • Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
  • Shelf Life: 24 months from manufacture date
  • More information, such as the product insert, clinical trial results, and CE documentation is available at request
  • Forensic/Professional Use Only
  • Procedural internal control included
  • Tests should be conducted by a licensed phlebotomist, or a medical professional
  • Verification of use case prior to shipping is mandatory

Validation: 

Clinical evaluation was carried out during February 2020 across 10 hospitals and reported on March 12, 2020. Further clinical evaluations are ongoing and any further information needed can be granted at request.

results.png

The results show that the testing reagent and reference reagent have equivalent effectiveness in detecting COVID-19 when tested in the same clinical specimens. Compared with the reference reagent, the positive agreement was 93.87% (95%CI:90.24%~96.46%), the negative agreement was 99.10% (95%CI:97.70%~99.75%) and 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.

Here is additional information on test limitations and validation: 

limitations-and-validation-of-test.png

Process: 

  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. (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. (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). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
  4. 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.

Interpretation of 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.

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.

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.

NOTE: Healgen is a wholly-owned subsidiary of Zhejiang Orient Gene Biotech Co.,Ltd

Antibody test kit boxes may have the Healgen or OrientGene name on them. The product is identical

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