SARS-CoV-2 Antigen Rapid Nasal Test Kit Single Pack

Rapid test kit (Colloidal gold immunochromatography) intended for the qualitative detection of antigen against SARSCoV-2 in clinical samples (nasal swab).
Rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens.
In clinical studies, the SARS-CoV-2 Rapid Antigen Test Nasal showed a relative sensitivity of 90.6% (Ct value ≤ 30; 95 % CI: 75.0 % – 98.0 %) and a specificity of 98.6% for professionally collected samples.
For self-collected samples, a sensitivity of 84.4 % (Ct value ≤ 30; 95 % CI: 67.2 % – 94.7 %) and a specificity of 99.2% was detected.
Overall, the studies contained 468 symptomatic and asymptomatic individuals.
The test is intended to detect antigen from SARS‑CoV‑2 in individuals suspected of COVID‑19 or with known or suspected exposure to SARS‑CoV‑2.
It is Intended for Professional use in Laboratory and Point of Care Environments, and/or self-collection under the close supervision of a healthcare worker.

• Non-invasive, simple to use
• Convenient, no device required
• Rapid, gets results in 15 minutes
• Stable, with high accuracy
• Inexpensive, cost-efficiency
  
• 12 months shelf life since manufacturing date (average shelf life of stock: 4 to 10 months)
• Storage condition: 4 ~ 30°C
• Contains ingle pack of 1 test card, 1 nasal swab and 10 monodose dropper

SARS-CoV-2 Rapid Antigen Test Characteristics

• Reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2
• Assay format: Lateral flow test / immunochromatographic
• Instrument: No
• Testing time: 15-30 minutes
• Specificity: 99.2%
• Sensitivity: 96.52% (Ct value ≤ 30)
• Antigen: N
• Sample material: Nasopharyngeal Swab
• Reagents: mAb anti-COVID19 antibody, mAb anti-Chicken IgY, mAb anti-COVID-19 antibody‑gold conjugate, Purified chicken IgY‑gold conjugate
• Available individually or in packs of 25

Limitations of COVID-19 antigen testing
No test is 100% accurate. All tests have limitations.
The antigen test is less accurate than the COVID-19 PCR test.
The test will find the virus in most people who have symptoms.
But in some cases, it may not pick up that you have the virus.
If you have COVID-19 symptoms, tell a healthcare worker immediately.

*Please note: Subject to correct condition of use and other factors. Instructions for use should be read properly and understood before use.