Testsealabs Covid-19 Antigen Test Cassette

Short Description:

● Sample type: Nasopharyngeal, oropharyngeal and nasal swabs

● Humanized Certification: Multi-countries registration,CE,TGA ,EU HSC, MHRA,BfrAm,PEI list

● 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: 25 tests/box ;5 test/box;1 test/box

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INTRODUCTION

The COVID-19 Antigen Test Cassette is a rapid test for the qualitative

detection of SARS-CoV-2 nucleocapsid antigen in Nasopharyngeal, oropharyngeal and nasal swabs specimen. It is used to aid in the diagnosis of SARS- CoV-2 infection with symptoms of COVID-19 within the first 7 days of symptom onset 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 Specimens	Nasopharyngeal, oropharyngeal and nasal swabs
Test duration	5-15 Mins
Pack size	25 tests/box ;5 test/box;1 test/box
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%)

INMATERIAL

Test device Prepackage extraction buffer

Package insert Sterile swab workstation

INDIRECTIONS FOR USE

Allow the test, sample and buffer to reach room temperature 15-30°before running.

Allow the test, sample and buffer to reach room temperature 15-30°C (59-86°F) before running.

① Place the extraction tube in the Workstation.

② Peel off aluminum foil seal from the top of the extraction tube containing the extraction tube containing the extraction buffer.

③ Have the nasopharyngeal, oropharyngeal or nasal swab carried out by a medically trained person as described.

④ Place the swab in the extraction tube. Rotate the swab for about 10 seconds

⑤ Remove the swab by rotating against the extraction vial while squeezing the sides of vial to release the liquid from the swab.properly discard the swab.while pressing the head of the swab against the inside of the extraction tube to expel as much liquid as possible from the swab.

⑥ Close the vial with the provided cap and push firmly onto the vial.

⑦ Mix thoroughly by flicking the bottom of the tube.Place 3 drops of the sample vertically into the sample window of the test cassette. Read the result after 10-15 minutes. Read the result within 20 minutes. Otherwise, a repetition of the test is recommended.

You can refer to Instuction Video:

ININTERPRETATION OF RESULTS

Two coloured lines will appear. One in the control region (C) and one in the test region (T). NOTE: the test is considered positive as soon as even a faint line appears. Positive result means that SARS-CoV-2 antigens were detected in your sample, and you're likely to be infected and presumed to be contagious. Refer to your relevant health authority for advice on whether a PCR test is
required to confirm your result.a

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.

1) 25 Test in one box, 750pcs in one carton

INPACKING DETAILS

2) 5 Test in one box, 600pcs in one carton

4) 1 Test in one box, 300pcs in one carton

INWe also have other COVID-19 Test Solution:

COVID-19 Rapid Test
Product name	Specimen	Format	Specification	Certificate
COVID-19 Antigen Test Cassette(Nasopharyngeal swab)	Nasopharyngeal swab	Cassette	25T	CE ISO TGA BfArm and PEI List
			5T
			1T
COVID-19 Antigen Test Cassette(Anterior Nasal(Nares)swab)	Anterior Nasal(Nares)swab	Cassette	25T	CE ISO TGA BfArm and PEI List
			5T
			1T
COVID-19 Antigen Test Cassette(Saliva)	Saliva	Cassette	20T	CE ISO BfArM List
			1T
SARS-CoV-2 Neutralizing Antibody Test Cassette(Colloidal Gold)	Blood	Cassette	20T	CE ISO
			1T
COVID-19 Antigen Test Cassette(Saliva)——Lollipop Style	Saliva	Midstream	20T	CE ISO
			1T
COVID-19 IgG/IgM Antibody Test Cassette	Blood	Cassette	20T	CE ISO
			1T	CE ISO
COVID-19 Antigen+Flu A+B Combo Test Cassette	Nasopharyngeal swab	Dipcard	25T	CE ISO
			1T	CE ISO