Product Details

Flow Flex COVID-19 Antigen Test

Manufacturer: ACON LABORATORIES, INC

MFG#: L031-118B5

NDC: NULL

PID: 672374

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Additional Information

Product NameFlow Flex COVID-19 Antigen Test
ApplicationRespiratory Test Kit
Contents Each kit contains test cassette, disposable nasal swab, extraction buffer tube, and package insert
Number of Tests48 tests
Reading TypeVisual read
Sample TypeNasal swab sample
SpecialtyImmunoassay
Test FormatCassette format
Test Kit TypeRapid
Test MethodLateral flow chromatographic immunoassay
Test NameCOVID-19 Antigen OTC
Test TypeAntigen detection
Time to Results15-minute results
Clinical PerformanceApproximately 93% sensitivity and 100% specificity under study conditions
Storage ConditionsStore at 2–30°C in a dry place away from direct sunlight
UsesRapid detection of SARS-CoV-2 antigen for screening, home testing, exposure assessment, and symptomatic evaluation

Description

Flowflex COVID-19 Antigen Home Test is an in vitro diagnostic rapid test authorized under FDA Emergency Use Authorization for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen. It is designed for non-prescription home use and supports early identification of COVID-19 infection in symptomatic and asymptomatic individuals. The test utilizes anterior nasal swab specimens for rapid screening.

The test operates using lateral flow chromatographic immunoassay technology to detect viral nucleocapsid antigens. When present, the antigen binds to specific antibodies on the test cassette, producing a visible result line. This format enables rapid visual interpretation without the need for laboratory equipment, providing results within a short analytical window.

Flowflex COVID-19 Antigen Home Test is intended for self-collected nasal swab samples from individuals aged 14 years and older, or adult-collected samples for individuals aged 2 years and older. It is applicable within the first 7 days of symptom onset or in cases where exposure or clinical suspicion of infection exists. Each kit includes a test cassette, sterile swab, extraction buffer tube, and instructions for use.

Frequently Asked Questions (FAQs)

The cost of Flow Flex COVID-19 Antigen Test is $available for registerd members only

Flow Flex COVID-19 Antigen Test is manufactured by ACON LABORATORIES, INC.