SARS-CoV-2 Virus Antigen Detection Kit (Colloidal Gold)-Home test

Short Description:

This Detection kit is for in vitro qualitative detection of SARS-CoV-2 antigen in nasal swab samples. This test is intended for non-prescription home use self-testing with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older who are suspected of COVID-19 or adult collected nasal swab samples from individuals under 15 years old who are suspected of COVID-19.


Product Detail

Product Tags

Product name

HWTS-RT062IA/B/C-SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal

Certificate

CE1434

Epidemiology

Coronavirus Disease 2019(COVID-19), is a pneumonia caused by infection with a novel coronavirus named as Severe Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2). SARS-CoV-2 is a novel coronavirus in β genus, enveloped particles in round or oval, with a diameter from 60 nm to 140 nm. Human is generally susceptible to SARS-CoV-2. The main sources of infection are the confirmed COVID-19 patients and asymptomatic carrier of SARSCoV-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:

SARS-CoV-2 Virus Antigen (investigational reagent) RT-PCR reagent Total
Positive Negative
Positive 97 0 97
Negative 7 450 457
Total 104 450 554
Sensitivity 93.27% 95.0% CI 86.62% - 97.25%
Specificity 100.00% 95.0% CI 99.18% - 100.00%
Total 98.74% 95.0% CI 97.41% - 99.49%

Technical Parameters

Storage temperature 4℃-30℃
Sample type Nasal swab samples
Shelf life 24 months
Auxiliary instruments Not required
Extra Consumables Not required
Detection time 15-20 mins
Specificity There is no cross-reactivity with pathogens such as human Coronavirus ( HCoV-OC43, HCoV-229E, HCoV-HKU1, HCoV-NL63), Novel influenza A H1N1 (2009), 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).

Work Flow

1. Sampling
● Gently insert the entire soft tip of the swab (usually 1/2 to 3/4 of an inch) into one nostril, Using medium pressure, rub the swab against all the inside walls of your nostril. Make at least 5 big circles. And each nostril must be swabbed for about 15 seconds.Using the same swab, repeat the same in your other nostril.

Sampling

Sample dissolving. Dip the swab completely into the sample extraction solution; Break the swab stick at the breaking point, leaving the soft end in the tube. Screw on the cap, invert 10 times and put the tube at a stable place.

2.Sample dissolving
2.Sample dissolving1

2. Perform the test
Put 3 drops of the processed extracted sample into the sample hole of the detection card, screw the cap.

Perform the test

3. Read the result (15-20mins)

Read the result

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