STANDARD Q COVID-19 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. This product is strictly for medical professional use only and not intended for personal use. The administration of the test and the interpretation of the results should be done by a trained health professional. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.
Technology: Lateral flow immunochromatographic test
Format: Cassette, 25 tests
Sample type: Nasopharyngeal swab
Clinical performance characteristics: Clinical performance evaluation was conducted by FIND with collaborators in Germany and Brazil with a total number of enrolled individuals of 1659, compared to the RT-PCR method.
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
Shelf life: 24 months from the date of manufacturing; do not use beyond its expiry date.
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 not freeze the kit.
Packaging & labelling:
Primary packaging: All contents of STANDARD Q COVID-19 Ag Test, kit of 25 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 is broken.
·Do not use the extraction buffer tube of another lot.
·Wear personal protective equipment, such as gloves and lab coats when handling kit reagents. Wash hands thoroughly after the tests are done.