Good Quality Covid-19 - SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold)-Home test – Macro & Micro-Test

Product name

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^[1]. 

Features

● Rapid: Read results in 15 minutes.
● Easy to use: Only 3 steps.
● Convenient: For self-test, home test.
● Room temperature: Transportation & storage at 4-30℃ for 24 months.
● Accuracy: High sensitivity & specificity.

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:

Technical Parameters

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.

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

3. Read the result (15-20mins)

Precautions:
1. Do not read the result after 20 mins.
2. After opening, please use the product within 1 hour.
3. Please add samples in strict accordance with the instructions.

Key Components

Reference

[1] New Coronavirus Pneumonia Diagnosis and Treatment Plan. (Eighth Edition), National Health Office Medical Letter [2020] No. 680