Product Description

SARS-CoV-2 Antigen Rapid Test Colloidal Gold for Self Testing for self testing is intended for the qualitative detection of SARS-CoV-2 Antigen (Nucleocapsid protein) in human saliva samples in vitro.

Product Detail

1. Product Introduction of SARS-CoV-2 Antigen Rapid Test Colloidal Gold for Self Testing

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) for self testing is intended for the qualitative detection of SARS-CoV-2 Antigen (Nucleocapsid protein) in human saliva samples in vitro.

Which are applied to the following scenarios:

1. mass population screening,such as hospital, airport, station, community, etc.

2. short-term continuous surveillance.

2. Product Features of SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) for self testing

* Anterior nasal swab specimen, noninvasive

* Very simple to use

* Convenient, no instrument required

* Rapid, results within 15~20 minutes

* Cost-efficient

3. How to detect SARS-CoV-2 virus?

The SARS-CoV-2 virus particle is made up of five components: an RNA gene chain and four proteins. The outermost layer of the particle is a Spike Protein (S), and the viral Envelope below the Spike is composed of Envelope Protein (E) and Membrane Protein (M). The core contained within the envelope is a helical folded structure composed of RNA gene chains and Nucleocapsid proteins (N). Using the principle of specific binding of antigen and antibody, the presence of SARS-CoV-2 antigen(Nucleocapsid protein) can be detected by antibody.

Advantages over Elisa and PCR

Method ELISA Kit RT-PCR Colloidal Gold Test Kit (Colloidal Gold)
Instrument Cost Expensive Expensive Cheap
Detection Time Longer Longer Short
Amplification
Specificity
Stronger Stronger Stronger
Environmental
Requirements
High High Low
Operation
Difficulty
High High Low

The performance of the SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) was established with 859 specimens prospectively collected from individual symptomatic patients who were suspected of COVID-19. Anterior nasal swab specimens were collected and tested according to the requirements of the Instructions for Use. The storage, transportation and detection of samples after collection met the relevant requirements of the Instructions for Use. At the same time, SARS-CoV-2 was detected by emergency nucleic acid detection reagent.

Clinical performance summary of the WIZ’S SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

Test Results Reference PCR Results
Positive Negative Total
Positive 328 0 328
Negative 14 517 531
Total 342 517 859

PPA: 95.91% (C.I. 93.25%~97.55%)

NPA: 100.00% (C.I. 99.26%~100.00%)

OPA: 98.37% (C.I. 97.28%~99.03%)

We, the manufacturer, herewith, declares that the product(s) as specified above meet(s) the applicable provisions of the European Directive 98/79/EC on in vitro Diagnostic Medical Devices. All supporting technical documentation demonstrating compliance is kept by the manufacturer and can be made available by the Authorized Representative in Europe.

4. Product Parameter of SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) for self testing

NO. Product Name Specimens Specifications
(T/Kit)
CE
Certification
1 SARS-CoV-2 Antigen Rapid Test nasopharyngeal/oropharyngeal
swab specimen collection
1/2/5/10/20/25 YES
2 SARS-CoV-2 Antigen Test nasopharyngeal/oropharyngeal
swab specimen collection
1/2/5/10/20/25 YES
3 SARS-CoV-2 Antigen Rapid Test (Saliva) Saliva 1/2/5/10/20/25 YES
4 SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) nasal swab specimen collection 1/2/5/10/20/25 YES
5 SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool) Sputum/Saliva/Faeces 1/2/5/10/20/25 YES

5. Product Details of SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) for self testing

6. Product Packing of SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) for self testing

Company Certification

Company Profile

Company Exhibition

6. Deliver,Shipping and Serving Of SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) for self testing

Shipping Method Shipping Terms Area
Express TNT /FEDEX /DHL/ UPS All Countries
Sea FOB/ CIF /CFR /DDU All Countries
Railway DDP Europe Countries
Ocean +Express DDP Europe Countries /USA/Canada/Australia /Southeast Asia /Middle East

7. FAQ of SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) for self testing

Q1. Are you factory or trading company?

A:Both.We have been in this field for more than 7years.With superior quality products and competitive price,we sincerely hope to develop mutual-beneficial business with our customers all over the world.


Q2. What is your terms of payment?

A: T/T,L/C,D/A,D/P and so on.


Q3. What is your terms of delivery?

A: EXW, FOB, CFR, CIF, DDU and so on.


Q4. How about the delivery time of SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) for self testing?

A: Normally, it will take 15 to 30 days after receiving the deposit The specific delivery time depends on the items and the quantity of your order.


Q5. Can you arrange production according to samples?

A: Yes, we can produce by your samples or technical drawings.


Q6. What is your sample policy?

A: If the quantity is small, the samples will be free, but the customers have to pay the courier cost.


Q7. Do you test all your goods before delivery?

A: Yes, we have 100% test before delivery.


Q8. How do you make our business long-term and good relationship?

A: We keep good quality and competitive price to ensure our customers benefit ; and we respect every customer as our friend and we sincerely do business and make friends with them.

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