Rapid Salivary Test Kit / Rapid Pharyngeal Nose Test Antigenic Detection SARS-CoV-2 (Kit 20 tests)

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Description

Salivary / Pharyngeal Nose Rapid Test Antigen Detection SARS-CoV-2

The Salivary / Nose Pharyngeal Antigen Cassette Test for SARS-CoV-2 is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens from nasal swab or saliva samples to facilitate the rapid diagnosis of SARS-CoV-2 viral infections. For professional in vitro diagnostic use only.

Principle of the Salivary/Nasal Rapid Antigenic Test

Detection of SARS-CoV-2 antigen in nasal/saliva swab specimens in the “T” band area of the cassette. After a nasal swab/saliva sample is loaded into the test well, it binds to the anti-SARS-CoV-2-N antibody coated particles that have been applied to the device.

This mixture chromatographically migrates the length of the test strip and interacts with the immobilized anti-SARS-CoV-2 antibody. If the sample contains the SARS-CoV-2 antigen, a colored band will appear in the area of the test strip indicating a positive result. If the sample does not contain SARS-CoV-2 antigen, no colored band will appear in this region, indicating a negative result. indicating a negative result. As a control of the procedure, a colored band will always appear in the control band area indicating that a sufficient volume of sample has been added and that the membrane is well imbibed.

What materials are provided with the salivary/nasal rapid antigen test?

Cassette test: 20
Saliva dropper: 20
Saliva collection container: 20
Extraction swab: 1
Extraction tube with dropper tip: 20
Package insert: 1
Workstation: 1

Materials required but not provided

Timer, disposable swab, containers and personal protective equipment: lab coat, gloves, goggles etc.

STORAGE AND SHELF LIFE

Store the SARS-CoV-2 antigen cassette test at 4-30°C in the sealed pouch in a dry environment and avoid direct sunlight. If in a high humidity environment, use immediately. DO NOT FREEZE. The test cassette must be used within 1 hour of opening the sealed pouch. Do not use after the expiration date.

Nasal Specimen Collection and Preparation

 

Nose sample collection and preparation

covid 19 rapid antigenic pharyngeal nose test kit

  • Incline the patient’s head back 70 degrees.
  • Gently rotate the swab, insert it less than one inch (approximately 2 cm) into the nostril parallel to the palate (not upward) until resistance from the turbinates is met.
  • Rotate the swab at least 5 times against the nasal wall, then slowly remove the swab as you rotate it.
  • Repeat in the other nostril using the same swab.
  • The swab collected with the sample should be tested as soon as possible.
  • If testing is not immediate, the swab should be placed in a sterile plastic tube labeled with the patient’s information and sealed tightly at room temperature (15-30°C) for up to 1 hour before testing.

Saliva sample collection and preparation

  • Optimal timing for sample collection: After getting up and before brushing your teeth, eating or drinking. For another collection time, please wait 30 minutes after you have
    eating, drinking, smoking, or chewing gum, before beginning saliva sample collection.
  • Carry out hand hygiene with water and alcohol-based hand soap/rub.
  • Open the container. Make a “kruuua” noise from the throat to release the saliva from the deep throat, then spit the saliva (about 2 ml) into the collection container.
  • The test should be performed immediately after sample collection.
  • If testing is not immediate, the swab should be placed in a sterile plastic tube labeled with the patient’s information and sealed tightly at room temperature (15-30°C) for up to 2 hours before testing.

Test procedure from nasal and nasopharyngeal samples

nose pharyngeal test covid 19

  • Let the test cassette, specimen, swab and/or controls equilibrate to room temperature at 15-30℃ (59-86℉) before testing.
  • Place the extraction tube in the workstation. Add 10 drops of extraction buffer into the extraction tube.
  • After collecting the sample, insert the swab into the extraction tube containing the swab and rotate the swab for approximately 10 seconds to dissolve sufficient amount of sample in the swab.
  • Remove the swab by pressing the head of the swab to release the remaining sample.
  • Dispose of the swab according to biohazard waste disposal protocol.
  • .
  • Remove one test cassette from the foil pouch by tearing the notch and place it on a flat surface.
  • Cap the extraction tube with the dropper tip and add 3 drops of the sample vertically into the well of the test cassette.
    test cassette.
  • Read the result after 15 minutes. The test result should not be read and interpreted after 20 minutes.

Saliva test procedure from saliva samples

salivary antigen test kit covid 19

  • Let the test cassette, sample, buffer and/or controls equilibrate to room temperature at 15-30°C (59-86°F) prior to testing.
  • Collect the saliva sample in the saliva collection container.
  • Place the extraction tube in the workstation. Add 10 drops of extraction buffer to the extraction tube, then transfer approximately 3 drops of fresh saliva from the container into the extraction tube.
  • The extraction tube should be placed in the workstation.
  • Tap the extraction tube with the droplet tip, shake, and completely mix the saliva and buffer.
  • Remove one test device from the foil pouch by tearing the notch and place it on a flat surface.
  • Add 3 drops of the sample vertically into the sample well of the test cassette.
  • Read the result after 15 minutes. The test result should not be read and interpreted after 20 minutes.

A procedural control is included in the test. A colored line appearing in the area of the control line (C) is considered an internal procedural control. It confirms sufficient sample volume, adequate membrane humidification, and proper procedural technique. Quality controls (positive control buffer and negative control buffer) are not included in the kit and can be purchased separately.

Interpretation of results

Positive: Two bands appear in the results window: test band (T) and control band (C) and the test is considered positive for SARS-CoV-2 antigen.
Negative: If only the control band (C) appears in the results window the test is considered negative for SARS-CoV-2 antigen.
Invalid: If the control band (C) does not appear, even though the test band (T) appears in the test area, it is considered an invalid result, please review the procedure and repeat the test
with a new test cassette. If the problem persists, stop using the test kit immediately and contact your local distributor

salivary test antigen covid 19 result

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