STANDARD Q COVID-19 Ag Test, kit/25T
STANDARD Q COVID-19 Ag Test is a rapid chromatographic immunoassay forthe qualitative detection of specific antigens to SARS-CoV-2 present inhuman nasopharynx. This test is for administration by healthcare workersand labs only, as an aid to early diagnosis of SARS-CoV-2 infection inpatient with clinical symptoms with SARS-CoV-2 infection. It providesonly an initial screening test result. This product is strictly formedical professional use only and not intended for personal use. Theadministration of the test and the interpretation of the results shouldbe done by a trained health professional. The result of this test shouldnot be the sole basis for the diagnosis; confirmatory testing isrequired.
Technology: Lateral flow immunochromatographic test
Format: Cassette, 25 tests
Sample type: Nasopharyngeal swab
Clinical performance characteristics: Clinical performance evaluationwas conducted by FIND with collaborators in Germany and Brazil with atotal number of enrolled individuals of 1659, compared to the RT-PCRmethod.
Clinical sensitivity (Germany) – 76.6%
Clinical specificity (Germany) – 99.3%
Clinical sensitivity (Brazil) – 88.7%
Clinical specificity (Brazil) – 97.6%
Reading time: 15-30 minutes
Manufacturer product reference: SD Biosensor, Q-NCOV-01G/09COV30D
Items supplied with:
·25 x Test device (individually in a foil pouch with desiccant)
·25 x Extraction buffer tube
·25 x Nozzle cap
·25 x Sterile swab
·1 x IFU
24 months from the date of manufacturing; do not use beyond its expirydate.
Weight & volume:
Estimated weight: 0.4kg
Estimated volume: 3.078 dm3
Storage & transportation condition:
Must be stored at 2 – 30°C, protect against direct sunlight. Do notfreeze the kit.
Packaging & labelling:
Primary packaging: All contents of STANDARD Q COVID-19 Ag Test, kit of25 tests
Secondary packaging: One kit STANDARD Q COVID-19 Ag Test, kit/25 tests
·Do not re-use the test kit.
·Do not use the test kit if the pouch is damaged or the seal isbroken.
·Do not use the extraction buffer tube of another lot.
·Wear personal protective equipment, such as gloves and lab coats whenhandling kit reagents. Wash hands thoroughly after the tests are done.
WHO EUAL – IFU can be found here: