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FASPIT™ SARS-CoV-2 Saliva Test

SARS-CoV-2 Antigen Saliva Test Kit is an immunoassay rapid test kit to detect SARS-CoV-2 nucleocapsid protein in saliva specimen, and is intended to be used as an aid in the diagnosis of the novel coronavirus pneumonia.

SARS-COV-2 Antigen Saliva Test Kit

Intended Use

FASPIT™ SARS-CoV-2 Antigen Saliva Test Kit (Colloidal Gold Immunochromatography) is an immunochromatographic membrane assay that uses the double-antibody sandwich method to detect the SARS-CoV-2 nucleocapsid protein from human saliva specimen, which are intended to be used as an aid in the diagnosis of novel coronavirus pneumonia.

SARS-CoV-2 Antigen Test Kit provides preliminary test results, and the test kit cannot be used as the sole basis for diagnosis, treatment or other management decision.

Can Mutant Virus Detected?

Until now, our SARS-COV-2 Antigen test kit can effectively detect the main variants of the virus.

SARS-CoV-2 Virus is a positive single-strand RNA virus, which could mutate rapidly, there have been a large number of gene sequencing reports on mutant viruses. Using Spike protein for detection has potential risk to be unable to identify mutant viruses. Atlas Link Technology Co., Ltd takes the nucleocapsid protein of the SARS-CoV-2 virus as the antigen marker in our SARS-CoV-2 Antigen Saliva Test Kit, which will technically guarantee its specificity and avoid the influence of the virus mutation to the effectiveness of the SARS-COV-2 antigen test.

FASPIT™ SARS-CoV-2 Antigen Saliva Test

For this newly developed COVID-19 antigen test kit, Atlas Link adopted a new trade name FASPIT™, which embodies the collection method of the saliva specimen; it is also a natural extension of our brand scope with the increase of our test kit series.

Why Use Saliva Test

Since the pandemic of SARS-COV-2, the antigen testing for large-scale screening has been urgently needed. Currently, the most commonly used method is to use Nasopharyngeal Swab (NPS) and Oropharyngeal Swab (OPS) for nucleic acid detection. But there are many reports that use of saliva samples for detection has the same level of detection as NPS.

Furthermore, collecting saliva samples can effectively reduce risk of virus transmission to healthcare provider and causes less individuals discomfort compared with NPS/OPS specimens.

The easiness of sample collection make it more convenient to perform the antigen detection test.

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

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
C2103 SARS-CoV-2 Antigen Saliva Test saliva 20 Bulk: 600 PCS
Boxed: 24 Boxes
How to Use

SARS-CoV-2 Antigen Saliva Test

General Information

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

Catalog No.:C2103
Description:SARS-CoV-2 Antigen Saliva Test
Category:Respiratory Tract Disease
Style:Card
Unit:PCS
Specimen:saliva
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:97.4%
Specificity:100%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:20 Tests
Box Dimension:24.8 * 13.3 * 7.8 CM
Kits per CTN:24 Kits
Carton Dimension:53 * 44 * 35 CM
Tests per CTN (BULK):600 Tests
Carton Volume:0.082 CBM
GW per CTN (Boxed):10.0 KG
GW per CTN (Bulk):12.5 KG

Materials Provided in the Test Kit

  • Test Cassettes (20×)
  • Assay Diluent (20×)
  • Disposable Saliva Collector (20×)
  • Disposable Extraction Droppers (20×)
  • Instruction for Use (1×)

Specimen

Saliva Collection

1. Rinse individual’s mouth with clear water and discard before test is recommended.

2. Wait for 5 mins before saliva collection.

3. Instruct individual to place their lips over the collecting funnel and collect saliva until the saliva reaches the indicator line (about 1ml).

(Attention: Do not eat, drink, smoke or use oral hygiene products for at least 10 minutes before the collection process)

saliva Storage Condition

The saliva specimens should be tested as soon as possible after collection.

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