STANDARD Q COVID-19 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of nucleocapsid 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.
Specimen – Nasopharyngeal
Test time – within 15 mins
Specimen – volume 3 drop
Sensitivity – Ct ≦ 25 : 97.14%(68/70), Ct ≦ 33 : 90.71%(127/140, overall : 84.97%(130/153)
Specificity – 98.94% (1490/1506)
Storage temperature – 2-30℃ / 36-86℉