Manufacturer for Rapid Test For Covid-19 - SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold)-Home test – Macro & Micro-Test

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Manufacturer for Rapid Test For Covid-19 - SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold)-Home test – Macro & Micro-Test Detail:

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:

SARS-CoV-2 Virus Antigen (investigational reagent)	RT-PCR reagent		Total
SARS-CoV-2 Virus Antigen (investigational reagent)	Positive	Negative	Total
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

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

Catalogue Number	Specification	Components	Quantity
HWTS-RT062I	1 test/kit	Test Card	1
		Sample Extraction Solution	1
		Disposable Swab	1
		Package Insert	1
HWTS-RT062IA	5 tests/kit	Test Card	5
		Sample Extraction Solution	5
		Disposable Swab	5
		Package Insert	1
HWTS-RT062IB	10 tests/kit	Test Card	10
		Sample Extraction Solution	10
		Disposable Swab	10
		Package Insert	1
HWTS-RT062IC	20 tests/kit	Test Card	20
		Sample Extraction Solution	20
		Disposable Swab	20
		Package Insert	1

Reference

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

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Covid-19