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SARS-CoV-2 Antigen Swab Test

NOVAtest ® SARS-CoV-2 Antigen Swab Test kits are intended to detect Sars-CoV-2 virus before symptoms appear, thus help to diagnose the infection of Sars-Cov-2 infection and control the spread of the virus.

SARS-COV-2 Antigen Nasal/Throat Swab Rapid Test Kit

Intended Use

SARS-CoV-2 Antigen Rapid throat/nasal swab test kit is an rapid immunoassay kit based on Colloidal Gold Immunochromatography principle, which uses the double antibody sandwich method to detect the novel coronavirus (SARS-CoV-2) antigen in the specimen from human throat and nasal swab. The test kits are intended to detect COVID-19 virus before symptoms appear, thus help in the diagnosis of COVID-19 infection, and help to control the epidemic of COVID-19 virus.

Sars-Cov-2 Test Kit for Self-Testing

This Sars-Cov-2 antigen Nasal/throat swab rapid test is easy to use; no extra reagent is needed; the result is easily read visually; the interpretation of the result is easy and simple; result can be obtained within 15 minutes. Because of these characters, this SARS-COV-2 Antigen test kit can be used as a point-of-care screening kit. And actually, a layman can easily perform this rapid test device.

changes in swab specimen collection for SARS-COV-2 detection

With the improvement of the test kits, especially with the improvement of the sensitivity, the specimen collect points are not restricted to the inner organs like nasopharynx cavity. Anterior nasal swab and Oropharyngeal Swab can also be used. This makes the collection of specimen much easier.

After reading the leaflet carefully, and if the assay procedures in the instruction leaflet can be followed strictly, the test can be totally used as self-testing device. Actually, our SARS-COV-2 antigen swab test kit has been approved by German authority to sell to the self-testing market (No.: 5640-S-122/21).

Variants and SARS-COV-2 Antigen Test

Three variants of Sars-Cov-2 virus have been found.

Variant P.1 contains 17 unique amino acid changes, three deletions, four synonymous mutations, and one 4nt insertion. Three of these mutations are of known biological importance: K417T, E484K, and N501Y.

VOC1 and VOC2 both contain multiple nucleotide changes across the genome which result in amino acid substitutions and other changes in different proteins. These include a large number of changes in the spike protein and a lesser number in the nucleocapsid protein.

The target antigen of our SARS-Cov-2 Antigen swab test and saliva test kits are the nucleocapsid protein, where there is little change. The antibody-antigen reaction works well with the variants. Therefore our products can detect the three above mentioned variants of Sars-Cov-2 virus.

SARS-CoV-2 Antigen Swab Test: Specimen Collection, Packing, Principle...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
nCOV 500 SARS-CoV-2 Antigen Swab Test Anterior Nasal & Oropharyngeal Swab 20 Bulk: 800 PCS
Boxed: 32 Boxes
nCOV 501 SARS-CoV-2 Ag Self-Test Kit Anterior Nasal & Oropharyngeal Swab 1 Bulk: 480 PCS
Boxed: 240 Boxes
nCOV 505 SARS-CoV-2 Ag 5-in Test Kit Anterior Nasal & Oropharyngeal Swab 5 Bulk: 700 PCS
Boxed: 80 Boxes
How to Use
Sars-Cov-2 Antigen Nasal/Throat Swab Rapid Test Kit

SARS-CoV-2 Antigen Swab Test

General Information

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

Catalog No.:nCOV 500
Description:SARS-CoV-2 Antigen Swab Test
Category:Respiratory Tract Disease
Style:Card
Unit:PCS
Specimen:Anterior Nasal & Oropharyngeal Swab
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:97.6%
Specificity:99.6%
Method:Lateral Flow Double Antibody Sandwich

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):10.3 KG
GW per CTN (Bulk):12.8 KG

Materials Provided in the Test Kit

  • 20 Test Cassettes in single pouch;
  • 2X8mL Extraction Reagent (Singe reagent available upon requirement);
  • 20 Specimen sampling swabs (Nasopharyngeal or Oropharyngeal);
  • 20 extraction dropper;
  • 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

SARS-CoV-2 Ag Self-Test Kit

General Information

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

Catalog No.:nCOV 501
Description:SARS-CoV-2 Ag Self-Test Kit
Category:Respiratory Tract Disease
Style:Card
Unit:PCS
Specimen:Anterior Nasal & Oropharyngeal Swab
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:97.6%
Specificity:99.6%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:1 Test
Box Dimension:18.5 * 6.0 * 1.5 CM
Kits per CTN:240 Kits
Carton Dimension:54 * 45 * 41 CM
Tests per CTN (BULK):480 Tests
Carton Volume:0.100 CBM
GW per CTN (Boxed):11.0 KG
GW per CTN (Bulk):22.0 KG

Materials Provided in the Test Kit

  • 1 Test Cassettes in single pouch;
  • Single Extraction Reagent;
  • 1 Specimen sampling swab (Nasopharyngeal or Oropharyngeal);
  • 1 extraction dropper;
  • 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

SARS-CoV-2 Ag 5-in Test Kit

General Information

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

Catalog No.:nCOV 505
Description:SARS-CoV-2 Ag 5-in Test Kit
Category:Respiratory Tract Disease
Style:Card
Unit:PCS
Specimen:Anterior Nasal & Oropharyngeal Swab
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:97.6%
Specificity:99.6%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:5 Tests
Box Dimension:18.5 * 6.0 * 8.0 CM
Kits per CTN:80 Kits
Carton Dimension:51 * 40 * 40 CM
Tests per CTN (BULK):700 Tests
Carton Volume:0.082 CBM
GW per CTN (Boxed):9.8 KG
GW per CTN (Bulk):17.0 KG

Materials Provided in the Test Kit

  • 5 Test Cassettes in single pouch;
  • 5X Single Extraction Reagent;
  • 5 Specimen sampling swab (Nasopharyngeal or Oropharyngeal);
  • 5 extraction dropper;
  • 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