SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)

Qualitative detection of SARS-CoV-2 antigen in anterior nasal swab samples. For non-prescription home self-testing by individuals aged 15 years and older, or adult-collected samples from children under 15 years, suspected of COVID-19.

SKU Code
AENE-RT062IA/B/C
Approval
On request
Product Type
Assay / Kit
Status
Available

Qualitative detection of SARS-CoV-2 antigen in anterior nasal swab samples. For non-prescription home self-testing by individuals aged 15 years and older, or adult-collected samples from children under 15 years, suspected of COVID-19.

Product typeAssay / Kit
Technology platformColloidal Gold
Application areaCOVID-19

Certificate

CE1434

Epidemiology

COVID-19, or Coronavirus Disease 2019, is a pneumonia caused by infection with the novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This virus belongs to the β genus and presents as round or oval enveloped particles, 60–140 nm in diameter. Humans show broad susceptibility to SARS-CoV-2. The main sources of infection are confirmed COVID-19 patients and asymptomatic carriers of SARS-CoV-2.

Clinical study

The performance of Antigen Detection Kit was evaluated in 554 patients of nasal swabs collected from symptomatic suspects of COVID-19 within 7 days post symptom onset compared to RT-PCR assay. The performance of the SARS-CoV-2 Ag Test Kit is as follows:

Work Flow

1. Sampling

  • Gently insert the soft tip of the swab (usually 1/2 to 3/4 of an inch) into one nostril. With medium pressure, rub the swab against all inner walls of the nostril, making at least 5 large circles for approximately 15 seconds.
  • Repeat the same process in the other nostril using the same swab.
  • Sample dissolving: fully immerse the swab in the extraction solution. Break the swab stick at the breaking point, leaving the soft tip in the tube. Cap the tube, invert it 10 times, and set it upright on a stable surface.

2. Perform the test
Add 3 drops of the processed extracted sample into the sample well of the detection card, then screw the cap.

3. Read the result (15-20 minutes)

SKU codeAENE-RT062IA/B/C
Storage temperature4℃-30℃
Sample typeNasal swab samples
Shelf life24 months
Auxiliary instrumentsNot required
Extra ConsumablesNot required
Detection time15-20 mins
SpecificityThere is no cross-reactivity with pathogens such as human Coronavirus ( HCoV-OC43, HCoV-229E, HCoV-HKU1, HCoV-NL63), Novel influenza A H1N1, seasonal influenza A (H1N1, H3N2, H5N1, H7N9), Influenza B (Yamagata, Victoria), Respiratory syncytial virus A/B, Parainfluenza virus(1, 2 and 3), Rhinovirus (A, B, C), Adenovirus (1, 2, 3, 4,5, 7, 55).
ApprovalOn request
DocumentsDatasheet, IFU, SDS, COA / conformance, origin, and export documents where available

FAQ

What should be confirmed before quotation?

Sample context, collection method, and extraction workflow should be confirmed before final kit selection.

Which documents can be requested?

Datasheet, IFU, SDS, COA / conformance, origin, insurance, and export documents can be checked where available.

Can the format be adjusted for different workflows?

Liquid or lyophilized format options should be confirmed together with instrument compatibility and shipment requirements.

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