This item has been discontinued.
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This COVID-19 test is a serologic test and looks for IgM (acute) and IgG (convalescent) antibodies to the virus, determining if the tested user has been previously infected with the disease. It will help assess if you have antibodies to the virus that causes COVID-19. An antibody test may not be able to show if you have a current infection, because it can take 1-3 weeks after infection to make antibodies. If you have a positive test result, it is possible that you have had a recent or prior COVID-19 infection and that you have developed an antibody response to the virus.
CLIA or NPI Number is required.
This product has been authorized by the FDA for Emergency Use Authorization (EUA) in CLIA certified laboratories. Please see link below to view the issued EUA letter of authorization:
https://www.fda.gov/media/139789/download
Fact Sheet for Healthcare Providers
Fact Sheet for Recipients
Instructions for Use
What are the known results:
FaSTEP (by Assure Tech)
Assure Tech. (Hangzhou) Co., Ltd., the manufacturer of FaSTEP performed clinical
trials at two sites in China from February 2020 to March 2020. These clinical trials were
aimed to evaluate the performance of the COVID-19 IgG/IgM Rapid Test Device (Whole
Blood/Serum/Plasma) against known patient PCR results:
IgM Testing
- 74/79 PCR+ patients who were also symptomatic also had a positive rapid
test for IgM (93.7% sensitivity)
- 225/227 PCR (-) patients had a negative rapid test (Specificity 99.1%)
IgG Testing
- 82/83 patients who had recovered from the disease were positive for IgG
(Sensitivity 98.8%)
- 224/227 PCR (-) patients had a negative rapid test (Specificity 98.7%)
Other Publications:
A recently accepted publication by Li, et.al. showed the following results:
- A total of 525 cases were tested: 397 (positive) clinically confirmed
(including PCR test) SARS-CoV-2-infected patients and 128 non-
SARS-CoV-2-infected patients (128 negative). The testing results of
venous blood with confirmed infection were summarized. Of the 397
blood samples from SARS-CoV-2-infected patients, 352 tested
positive, resulting in a sensitivity of 88.66%. 12 of the blood samples
from the 128 non-SARS-CoV-2 infection patients tested positive,
generating a specificity of 90.63%. It was also found that 64.48%
(256 out of 397) of positive patients had both IgM and IgG antibodies.
- Manufacturers of these tests state the possibility of cross reactivity with
seasonal Coronaviridae
What are the upsides: