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SARS-Cov-2 and Influenza A/B Combo Test

This NOVAtest ® combo test panel is used to visually detect and differentiate three antigens in human nasal/throat swab specimen, i.e. SARS-COV-2 antigen, Influenza A antigen and Influenza B antigen.

SARS-COV-2 & influzenza A+B Antigen Combo Test Panel

Intended Use

This NOVAtest ® rapid test kit is a combo test panel for the same time detection and differentiation of novel coronavirus (SARS-CoV-2) and influenza A+B antigens in nasopharyngeal swab samples.

The product is designed to be used for population screening in the early phase of diseases outbreaks. Results are for the identification and differentiation of SARS-CoV-2 nucleocapsid, influenza A antigen and influenza B antigen. These antigens are generally detectable in the specimens from upper respiratory tract during the acute phase of infection.

How the Combo Test Helps

Because there are many similar clinical symptoms in the cases of SARS-CoV-2, influenza A, and influenza B, this combo test device can help to reduce the confusion in the diagnosis of these infections, thus proper administration measure can be taken timely to alleviate the symptoms, and proper control measures can be taken to avoid the wide spread of the viruses.

What is SARS-COV-2

Novel coronavirus pneumonia is an infectious disease caused by SARS- CoV-2 infection. SARS-CoV-2 is a novel coronavirus, which was once called COVID-19 when it was first reported in 2019. On February 11, 2020, the International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2.

So far, there have been seven types of human coronavirus (HCoV) that cause respiratory diseases in humans: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and SARS-CoV-2.

The clinical manifestation of systemic symptoms such as fever, fatigue, dry cough, dyspnea, etc., and can rapidly develop severe pneumonia, respiratory failure, acute respiratory distress syndrome, septic shock and multiple organ failure, severe alkali metabolic disorders, etc., and can can be fatal especially when the patient has chronic diseases.

SARS-CoV-2 + Influenza A&B Test: Specimen Collection, Packing, Principle...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
nCoVf 501 SARS-CoV-2 + Flu A&B Test Anterior Nasal & Oropharyngeal Swab 20 Bulk: 800 PCS
Boxed: 32 Boxes
How to Use

SARS-CoV-2 + Flu A&B Test

General Information

(IVD Kit »-» Respiratory Tract Disease -» One Step Lateral Flow Immunochromatographic Assay)

Category:Respiratory Tract Disease
Description:SARS-CoV-2 + Flu A&B Test
Specimen:Anterior Nasal & Oropharyngeal Swab
Style:Panel
Reading Time:15 Minutes
Specification:4.0 mm
No. of Step:One Step
Quan. or Qual.:Qualitative
Sensitivity of SARS-COV-2:97.6%
Specificity of SARS-COV-2:99.6%
Sensitivity of Influenza A:95.3%
Specificity of Influenza A:99.1%
Sensitivity of Influenza B:94.7%
Specificity of Influenza B:98.5%

Packing Specification

Tests per Kit:20 Tests
Box Dimension:21.0 * 12.3 * 8.1 CM
Kits per CTN:32 Kits
Carton Dimension:53 * 44 * 35 CM
Tests per CTN (BULK):800 Tests
Carton Volume:0.082 CBM
GW per CTN (Boxed):13.0 KG
GW per CTN (Bulk):16.2 KG

Materials Provided in the Test Kit

  • 20 test cassettes
  • 2× 6mL assay diluent
  • 20 specimen sampling swabs
  • 20 single use extraction droppers
  • 1 workstation to stand the extraction tubes
  • Instruction for use

Specimen

Oropharyngeal Swab

1. Ask the individual to face upward and open the mouth until exposing the pharyngeal tonsils on both sides.

2. Wipe the base of the tongue with a cotton swab, gently wipe pharyngeal tonsils back and forth on both sides for at least 3 times, and then wipe the posterior pharyngeal wall up and down for at least 3 times.

Anterior Nasal Swab

1. To collect nasal swab specimen, inert the swab into one nostril until the soft tip of the swab is not visible.

2. Rotate it in a circle around the inside edge of the nostril for at least 3 times.

3. And then use the same tip to repeat the procedure in the other nostril 3 times.

Anterior Nasal & Oropharyngeal Swab Storage Condition

It is recommended that swab specimens be processed as soon as possible after collection.

If swabs are not processed immediately they should be placed into a dry, sterile, and tightly sealed plastic tube for storage. Swabs can be stored dry at room temperature for up to 24 hours.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle