One Step Test for SARS-CoV-2 Antigen (Colloidal Gold)

Getein One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.

  • Test Item:

    SARS-CoV-2 Antigen
  • Sample Type:

    Human nasal swab
  • Test Time:

    10-15 min
  • Methodology:

    Colloidal Gold

One Step Test for SARS-CoV-2 Antigen

(Colloidal Gold)




Intended Use

One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples from patients suspected of COVID-19 infection by a healthcare provider.

About SARS-CoV-2

The novel coronaviruses belong to the β genus. SARS-CoV-2 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.


Contents

A kit contains:

Package specifications: 25 tests/box

1) Getein SARS-CoV-2 antigen test card in a sealed pouch with desiccant

2) Sample extraction solution: 25 tubes/box

3) Sampling swab: 25 pieces/box

4) Disposable pipette: 25 pieces/box

5) User manual: 1 piece/box

Note: Do not mix or interchange different batches of kits.


Specifications


Test Item

Sample

Storage Condition

SARS-CoV-2 Antigen

Human nasal swab

4-30

Method

Test Time

Shelf Life

Colloidal Gold

10-15 min

24 months


Operation

 Nasal Swab Sampling 




Sample Pretreatment 


  Test  

                                                                                                                               



Results

1. Valid Test

Positive (+):

Two bands appear, one at the control area (C) and the other at the test line (T). the result indicates the presence of SARS-CoV-2 antigen.

Negative (-):

A single band appears at the control area (C) and no other band at test line. The result indicates that sample dose not contain SARS-CoV-2 antigen.



2. Invalid Test

If no band appears in the control area (C), the test result is invalid. The test should be repeated with a new test card and if the same situation reappears, please stop using this batch of products and contact your supplier.



Clinical Application

1. This test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.

2. This test is only intended for professional and laboratory use, not for home testing.

3. Results from the test should not be used as the sole basis for diagnosis and exclusion of SARS-CoV-2 infection.

4. As it is a novel disease diagnosis of which are being explored, please refer to the latest guidelines for diagnosis and treatment of COVID-19.



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