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.
INTENDED USE:
SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) is to be used in conjunction with clinical manifestations and other laboratory test results to assist in the diagnosis of patients with suspected SARS CoV-2 infection. It provides only aninitial screening test result and more specific alternative diagnosis methods should be performed in order to obtain the confirmation of SARS-CoV-2 infection. for professional use only.
SPECIMEN COLLECTION AND PREPARATION:
Nasopharyngeal Swab Specimen Collection:
1.Tilt patient's head back 70 degrees.
2.Insert swab into nostril. (Swab should reach depth equal to distance from nostrils to outer opening of the ear.) Leave swab in place for several seconds to absorb secretions.
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 transportation of etiological agents.
INTERPRETATION OF TEST RESULTS:
1. 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.
2.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.
3. 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.
1. Sensitivity and Specificity
The SARS-CoV-2 Antigen Rapid Detection Kit was compared with a leading commercial reagent (PCR); the results show that SARS-CoV-2 Antigen Rapid Detection Kit has high sensitivity and specificity.
Sensitivity=98.90 % (95% CI: 97.98%~99.82%)
Specificity=98.11 % (95% CI: 99.92%~99.30%)
Accuracy: 98.40% (95%CI 97.29% 99.50%)
List:
1×Test kit
1×Swabs
1×Sample Lysis Solution
1×Instructions for use
1×Certificate of conformity
