Assure Tech COVID-19 IgG/IgM Rapid Test Device, Germaine Laboratories
76478-966
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- Description:COVID-19 IgG/IgM rapid test kit
- Sample Type:Human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
- Cat. No.:76478-966
The point-of-care (POC)/waived/fingerstick Fastep® COVID-19 IgG/IgM rapid test device by Assure Tech. is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma.
- Combined specificity 98.8%
- Combined sensitivity 100%
- Results in 15 minutes
- FDA EUA CLIA Waived
Rapid lateral flow chromatographic immunoassay for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Identify individuals with an adaptive immune response to SARS-CoV-2.
: FDA EUA CLIA Waived.
: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a.
: Includes: 20 tests/kit, disposable pipettes, sterile safety lancets, alcohol prep pads, buffer and package insert.
: FDA EUA CLIA Waived authorization- fingerstick blood samples can now be tested in POC (Point of Care) setting such as doctor's offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing. under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a. Device should not be used to diagnose acute SARS-CoV-2 infection.