Testsealabs Covid-19 Antigen (SARS-CoV-2) Test Cassette(Saliva-Lollipop Style）

Short Description:

●Sample type: saliva one ;

●Humanized – Avoid the discomfort and bleeding caused by improper operation, suitable for children, the old and

the other patients.;

●Self-test, continuous self-monitoring of health status,early detection,

early isolation, early treatment

●High sensitivity, form the first line of defense of COVID-19 screening,

reduce the pressure of medical institutions

●Suitable for multiple scenarios: medical institution testing; screening

before resumption of work and school,continuous monitoring, etc.

●All necessary reagent provided & No equipment required;

●Time saving procedures, results are available in 15 minutes;

●Storage temperature: 4~30 ℃ . No cold-chain

●transportation needed; Specification: 20 tests/box ;1 test/box

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Product Detail

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INTRODUCTION

The COVID-19 Antigen Test Cassette is a rapid test for the qualitativedetection of SARS-CoV-2 nucleocapsid antigen in Saliva specimen. It isused to aid in the diagnosis of SARS- CoV-2 infection that may lead to COVID-19 disease. It can be direct detection of pathogen S protein not affected by virus mutation, saliva specimens , high sensitivity & specificity and can be used for early screening .

Assay type	Lateral flow PC test
Test type	Qualitative
Test material	Saliva-Lollipop Style
Test duration	5-15 Mins
Pack size	20tests/1 test
Storage temperature	4-30℃
Shelf life	2 years
Sensitivity	141/150=94.0%(95%CI*(88.8%-97.0%)
Specificity	299/300=99.7%(95%CI*:98.5%-99.1%)

PRODUCT FEATURE

MATERIAL

Test devices、Package insert

DIRECTIONS FOR USE

Attention：Do not eat, drink, smoke or smoke electronic cigarettes within 30 minutes before the test.Do not eat foods that contain or may contain nitrite within 24 hours before the test (such as pickles, cured meats and other preserved products)

① Open the bag, take out the cassette from the package, and place it on a clean, level surface.

② Remove the lid and put the cotton core directly under the tongue for two minutes to soak the saliva. The wick must be immersed in the saliva for two (2) minutes or until the liquid appears in the viewing window of test cassette

③ After two minutes, remove the test object from the sample or under the tongue, close the lid, and place it on a flat surface.

④ Start the timer. Read the result after 15 minutes.

You can refer to Instuction Video:

INTERPRETATION OF RESULTS

Positive: Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the test line region.

Negative: One colored line appear in the control region(C).No apparent

colored line appear in the test line region.

Invalid: Control line fail to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure.

PACKING DETAILS

A.One Test in One box
*One test cassette+one instruction use+one quality of certification in one box
*300 boxes in one carton , carton size : 57*38*37.5cm, *one carton weight about 8.5kg.

B.20 Tests in One box
*20 test cassette+one instruction use+one quality of certification in one box；
* 30 boxes in one carton , carton size : 47*43*34.5cm,
* one carton weight about 10.0kg.