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Short Description

ROCHE SARS-CoV-2 rapid Antigen Test (ART)

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The SARS-CoV-2 virus causes respiratory tract infection. It is transmitted mainly via respiratory droplets after close contact, and primary viral replication is presumed to occur in mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx).1 At these locations viral load peaks within the first week after symptom onset, and then declines.2

A SARS-CoV-2 antigen test detects the presence of the SARS-CoV-2 virus  from part of the upper respiratory tract swab specimens by identifying a nucleoprotein that is carried by the virus. The test identifies current infection during the acute phase of COVID-19, while the virus is still present in large quantities in the respiratory tract.

Features and benefits of the SARS-CoV-2 Rapid Antigen Test

Besides laboratory PCR testing, antigen assays can also be offered as rapid testing in near-patient settings. The SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of specific antigens of SARS?CoV?2 present in nasopharyngeal or combined nasopharyngeal/oropharyngeal samples. This test is intended to detect antigen from the SARS?CoV?2 virus in individuals suspected of COVID?19. This product is strictly intended for professional use in laboratory and Point of Care environments.  Similar to laboratory instruments, it detects a SARS-CoV-2 antigen, the nucleoprotein. It can therefore be used to assess whether a person is infected with SARS-CoV-2 by providing a qualitative result showing coloured bands indicating the presence of SARS-CoV-2 antigens.

The SARS-CoV-2 Rapid Antigen Test enables fast decision making e.g.  whether patients need to be put in quarantine, reducing the risk of further spreading. In addition to that it allows for screening of individuals after confirmed exposure to a SARS-CoV-2 infected person or individuals at risk of exposure such as healthcare workers.

The SARS-CoV-2 Rapid Antigen Test allows for decentralized testing at the point of care and helps to expand the range and quantity of direct virus testing into otherwise inaccessible locations. Rapid point of care testing can sometimes be the only viable option if lab testing is not sufficiently available. In addition to that, the SARS-CoV-2 Rapid Antigen Test is an instrument free test, allowing testing in rural/ low-infrastructure areas.

The benefits of the SARS-CoV-2 Rapid Antigen Test in short:

  • Getting a quick result within 15-30 minutes – no need for a follow-up appointment to discuss the result
  • Easy handling which does not require specific training
  • No instrument required
  • Allowing decentralized testing or access to testing in areas where laboratory testing is not available

Testing the quick and easy way

Testing process for the SARS-CoV-2 Rapid Antigen Test15

Testing process

1. Collecting a sample (nasypharyngeal swab)*

 

Insert a sterile swab into the nostril of the patient and then rotate the swab 3-4 times against the nasopharyngeal surface. Withdraw the swab from the nasal cavity.

*When collecting a combined NP/OP sample be sure to follow the procedures described in the Instructions for Use.

Testing process

2a. Preparing a sample

Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 5 times.

Testing process

2b. Preparing a sample

Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.

Testing process

2c. Preparing a sample

Press the nozzle cap tightly onto the tube. Continue with 3a. Performing a test.

Testing process

3a. Performing a test

 

Place the test device on a flat surface and apply 3 drops of extracted sample in a 90° angle to the specimen well of the test device.

Testing process

3b. Performing a test

Read the test result at 15 to 30 min.

Warning: Risk of incorrect results. Do not read the test result after 30 min.

Testing process

4. Interpreting results

 

A colored line appears in the top section of the result window to show that the test is working properly. This is the control line (C). Even if the control line is faint, the test should be considered to have been performed properly. If no control line is visible the test is invalid. 

In case of a positive result, a colored line appears in the lower section of the result window. This is the test line (T). Even if the test line is very faint or not uniform, the test result should be interpreted as a positive result.

 

Test kit information

The kit is ready for use and contains all equipment needed to perform a test.

The following components are needed for a test and included in the kit:

  • Test device (individually in a foil pouch with desiccant)
  • Extraction buffer tube
  • Nozzle cap
  • Sterile swab
  • Film (can be attached to the test device when performing outdoor testing) 
  • Instructions for use
  • Quick Reference Guide

 

SARS-CoV-2-Antigen-test-kit

Standard warranty covered by the seller against any manufacturing defect. In such events, please report to us within 7 days from the date of delivery at connect@lumiere32.sg.

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