Rapid immunochromatographic SARS-CoV-2 Antibody Test based on Colloidal Gold method. The test is authorized for sale under the FDA-EUA in the United States and CE-IVD in the EU. Tests allow for room temperature storage.
These test kits are validated to FDA’s exacting standards by multiple clinical studies. Based on nearly 2,000 clinical tests, the test data shows 99.5% Specificity and 97.5% Sensitivity. More than 1,800 tests were conducted by Anhui Medical University (Hefei, Anhui, China), with further results from 83 tests validated by the Yale School of Public Health (New Haven, CT, USA).
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Product Features & Benefits
- Flexible: Serum, plasma, whole blood or peripheral blood can be used. Just 10 μl is needed per sample
- Reliable: Kits are in stock with production capacity of 1M units per day
- Cost-efficient: Tests deliver fast results, providing quantitative visual interpretation within 15 minutes
- Simple: Easy-to-use kits come complete with all required reagents
- Precise: Test accuracy is 99.1%
The SARS-CoV-2 IgM/IgG Antibody Test Kit includes all items needed for testing.
|Test card||25 x 1 each
|Sample diluent||1 x
|Small dropper||25 x 1 each
|Large dropper||3 x 1 each
|Instructions for use||1 x
Q: What is the intended use of the product?
A: The product is intended for the in vitro qualitative detection of SARS CoV-2 IgM and IgG antibodies from human serum, plasma and whole blood samples. The product is intended for the auxiliary diagnosis of SARS CoV-2 infection.
Q: How many procedural steps are there to complete the test using this product?
A: There are five simple procedural steps. Refer to the Instructions for Use (IFU) for more details.
Q: What sample types are used with the product?
A: Human serum, plasma and whole blood
Q: What is the response time?
A: The response time is 15 minutes.
Q: How much sample amount is required?
A: Ten µL of sample is enough to perform the test.
Q: Is there any additional instrumentation required to perform the test?
A: No additional instrumentation is required.
Q: What are the kit components?
A: The kit includes the following:
• Instructions for Use (IFU)
• test cassette
• small pipette
• large pipette
• sample diluent
Q: Are there any additional materials required that are not included with the product?
A: The following additional materials are required that are not included with the product:
• sample collection tube
Q: What clinical evaluation has been performed with the product?
A: Results have been validated by nearly 2,000 clinical tests. A retrospective study was carried out with 226 samples from the First Affiliated Hospital of Anhui Medical University, including 78 samples of other respiratory tract infections, 108 samples of normal people and 40 samples confirmed positive for SARS-CoV-2 infection (Recovery period sample). All samples were tested with SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method). Refer to the IFU for more details of the study.
Q: When is the product available?
A: Our COVID-19 Antibody Detection Kits are available now. We have established production capacity of up to one million units per day.
Q: Is the test FDA approved?
A: We have been granted the FDA’s Emergency Use Authorization (EUA) for our COVID-19 Antibody Detection Kits.
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