Covid-19 Rapid Antigen Test Kit

Features

Fast results within 30 mins
Easy to use
Specimen: Nasopharyngeal swab
All necessary reagents provided & no equipment needed
DescriptionCovid-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. ?
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Key SpecificationsLIMITATION 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.? ? ? ? ? ? ??

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Test time
Within 30 mins

Specimen
Nasopharyngeal swab

Storage temperature
2-30?/36-86?

Packaging
Test Device?
extraction buffer tube
nozzle cap
sterile swab
Direction to UseSTEP 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. ?FAQsHave doubts regarding this product?Post Your Question