SARS-CoV-2 Antigen Rapid Test Kit

Description

The Antigen Rapid Test Kit is an immunochromatographic assay for rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19.

This test is authorised for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.

Why buy from us?

• Unique QR code on each test cassette.
• CE Marked, FDA authorized under a EUA Lateral Flow Antigen test kit.
• Nasal Specimen sample.
• Easy to operate.
• All required accessories are provided in the test kit.
• Simple to use and fast results.
• For ages 2 to adult.

Storage

Store at room temperature between 2-30°C.

Results

Positive result: Both the “T” position and Control “C” position appear visible colour lines. If the “T” test shows a faint colour, the result is also positive.

Negative result: Only the Control “C” position appears colour, while the test “T” position is blank.

Invalid Result: If the control “C” position and Control “T” position remain blank, the result is invalid because the detecting function is failed to work and retest is required.

Material provided

• Cassettes.
• Individually wrapped specimen sampling sterile swab.
• Extraction tubes.
• Nozzle for extraction tubes.
• Bottle of sample extraction buffer.
• Instruction for use.

Performance Characteristics

Sensitivity: 82.14% (23/28), in comparison with nucleic acid amplification test confirmed positive cases. Specificity: 99.45% (180/181), the negative cases were also confirmed by nucleic acid amplification test. Cross reactivity: There is no cross reactivity with influenza A virus, influenza B virus, adenovirus, Coxsackie virus, ECHO virus and enterovirus; no cross reactivity with Chlamydia pneumoniae, Mycoplasma pneumoniae, Chlamydia psittaci and Chlamydia trachomatis; no cross reactivity with Acinetobacter baumannii, Bordetella pertussis, Candida albicans, Escherichia coli, Haemophilus influenzae and Neisseria gonorrhoeae.