Brand: Healgen Orient Gene Sample type: Nasopharyngeal swab;oropharyngeal swab Storage condition: Store as packaged in the sealed pouch at the temperature (4-30鈩?or 40-86鈩?. Shelf Life: 24 months from the date of manufacture Certificate: FDA, CE Packing Specification: 25 test/ box. Kit Contents: 20 Test Cassettes 1 Package Insert 20 Extraction Tubes 20 Dropper Tips 20 Sterilized Swabs 2 Extraction Reagents The Rapid COVID-19 Rapid Diagnostic Test Kit is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. Specimen collection Use the nasopharyngeal swab supplied in the kit. 1. Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx. that presents the most secretion under visual inspection. 2. Swab over the surface of the posterior nasopharynx. Rotate the swab several times. 3. Withdraw the swab from the nasal cavity. Test procedure & interpretation of results 1.POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result. 2.NEGATIVE: The presence of only control line(C) within the result window indicates a negative reslut. 3.INVALID If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are becasue of not fellowing the directions correctly or the test my have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test. Clinical Evaluation Positive Percent Agreement (PPA): 95.7% Negative Percent Agreement (NPA): 99.6% Overall Percent Agreement (OPA): 98.9% Features: Qualitative, visually read results in 15 minutes No instrument required Procedural internal control includedWholesale COVID-19 Test website:http://www.rapidtestcn.com/covid-19-test/