The novel corona-virus (2019-nCoV, SARS-CoV-2) is a new strain that has not been previously identified in humans and was discovered in 2019. The clinical manifestations are systemic symptoms such as fever and fatigue, accompanied by dry cough and dyspnea, etc., which can rapidly develop into severe pneumonia, respiratory failure, and acute breathing. Distress syndrome, septic shock, multiple organ failure, severe acid-base metabolism disorders, etc.
PRODUCT SPECIFICATION: 1 Test/Kit
SPECIMEN COLLECTION AND PREPARATION:
Posterior oropharyngeal saliva:
Perform hand hygiene with soap and water /alcohol-based hand rub.
1. Open the container. Make a “Kruuua” noise from the throat to clear the saliva from deep throat，then spit saliva (about 2 ml) into the container. Avoid any saliva contamination of the outer surface of the container.
2. Optimal timing of specimen collection: After getting up and before brushing teeth, eating or drinking.
Specimen Transport and Storage:
Freshly collected specimen should be processed as soon as possible. If specimens are to be transported, they should be packed in compliance with local regulations covering the trans-portation of etiological agents.
INTERPRETATION OF TEST RESULTS:
Positive Result
Colored bands appear at both test line (T) and control line (C). It indicates a positive result for the SARS-CoV-2 antigens in the specimen.
Negative Result
Colored band appear at control line (C) only. It indicates that the concentration of the SARS-CoV-2 antigens does not exist or below the detection limit of the test.
Invalid Result
No visible colored band appears at control line after performing the test. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen be re-tested.
Sensitivity and Specificity
The SARS-CoV-2 Saliva Antigen Rapid Detection Kit was compared with a leading commercial reagent (PCR); the results show that SARS-CoV-2 Saliva Antigen Rapid Detection Kit has high sensitivity and specificity.
Relative Sensitivity: 97.39% (95%CI： 96.13%98.65%)
Relative Specificity: 98.54% (95%CI：97.59%〜99.49%)
Accuracy: 98.04% (95%CI：96.94%〜99.14%)
1× Test kit
1×Sample Lysis Solution
1×Disposable dropper
1×Instructions for use
1×Certificate of conformity
