Covid - 19 Rapid Antigen Test Kit (Pack Of 25)

Features
Fast results within 30 mins

Easy to use

Specimen: Nasopharyngeal swab

All necessary reagents provided & no equipment needed



Description
Covid-19 Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx.

CLINICAL EVALUATION:
Performance characteristic for the Covid-19 Antigen Test Kit for rapid detection SARS-COV-2 antigen was established in a prospective, single institute, randomized, a single-blinded study conducted at a trial site in Malaysia during the 2020 SARS-CoV-2 pandemic situation. A total of 202 prospective specimens were tested using the Covid-19 Antigen Test Kit. These specimens consisted of nasopharyngeal swabs from symptomatic patients. The performance of the Covid-19 Antigen Test Kit was compared to a commercialized molecular assay.  
TEST SENSITIVITY:
The Covid-19 Antigen Test Kit showed 84.38% of sensitivity.  

Key Specifications
LIMITATION OF TEST:-

The test procedure, precautions, and interpretations of results for this test must be followed strictly when testing.
The test should be used for the detection of SARS-CoV-2 antigen in human nasopharyngeal swab specimens.
Neither the quantitative value nor the rate of SARS-CoV-2 antigen concentration can be determined by this qualitative test.
Failure to follow the test procedure and interpretation of test results may adversely affect test performance and/or produce invalid results.
Negative test results may occur if the level of an extracted antigen in a specimen is below the sensitivity of the test or if a poor quality specimen is obtained.
For more accuracy of immune status, additional follow-up testing using other laboratory methods is recommended.
The test results must always be evaluated with other data available to the physician.
A negative result may occur if the concentration of antigen or antibody in a specimen is below the detection limit of the test or if the specimen was collected or transported improperly, therefore a negative test result does not eliminate the possibility of SARS-CoV-2 infection, and should be confirmed by viral culture or a molecular assay or ELISA.
Positive test results do not rule out co-infections with other pathogens.
Negative test results are not intended to rule in other coronavirus infections except the SARS-CoV-1. 
Children tend to shed virus for longer periods of time than adults, which may result in differences in sensitivity between adults and children.              

 



Test time
Within 30 mins


Specimen
Nasopharyngeal swab


Storage temperature
2-30?/36-86?



Packaging
Pack Of 25

Direction of use
STEP 1:- Insert a sterile swab into the nostrils of the patients, reaching the surface of the posterior nasopharynx. 
STEP 2:- Swab over the surface of the posterior nasopharynx. 
STEP 3:- Withdraw the sterile swab from the nasal cavity.
STEP 4:- Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 5 times.
STEP 5:- Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
STEP 6:- Press the nozzle cap tightly onto the tube.
STEP 7:- Apply 3 drops of the extracted specimen to the specimen well of the test device.
STEP 8:- Read the test result in 15-30 minutes.