Contents (Cat No. 09COV33D):
Test device (individually in a foil pouch with desiccant) x25
Extraction buffer tube x25
Nozzle cap x25
Sterile swab x25
Buffer tube rack x2
STANDARD COVID-19 Ag Positive Control swab x1
STANDARD Respiratory Negative Control swab x1
Instructions for use x1
General description:
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.
Kit storage and stability:
Store the kit at 2-30°C / 36-86°F out of direct sunlight. Kit materials are stable until the expiration date printed on the outer box. Do not freeze the kit.
Clinical evaluation
Clinical performance of STANDARD Q COVID-19 Ag Test was evaluated using 503 nasal samples at Central Research Lab in Bangalore, India. FDA EUAauthorized RT-PCR test (EURO Real Time SARS-CoV-2) was used as the comparator method in the study.
The positive percent agreement of STANDARD Q COVID-19 Ag Test using nasal swab as specimen and RT-PCR Test as reference assay is 97.12% (95% CI, 91.86 – 99.01%) and the negative percent agreement is 100% (95% CI, 99.05 – 100%).
Sensitivity: 97.12% (95% CI, 91.86% – 99.01%)
Specificity: 100% (95% CI, 99.05% – 100%)
