COVID19Check-SAL

Antigenic Rapid Test - Saliva sample
Multi-G's Covid19Check-SAL Antigenic Rapid Test for COVID-19 is used to qualitatively detect SARS-CoV-2 antigen in saliva samples.
It is non invasive and painless. It allows easy and hassle free multiple testing. Covid19Check-SAL detects the known variants of the Sars-Cov-2 virus.

The test

There is a critical, global need for rapid antigen test that can complement nucleic acid (PCR) tests for diagnosing SARS-CoV-2 infection. Although critically important, PCR tests are not always available and can last too long in obtaining the result due to the large amount of people who need testing.

Additionally there is growing concern about the acceptability of the very uncomfortable nasopharyngeal swab sampling, especially as testing it is becoming more frequent to secure most daily activities.

Covid19Check-SAL is an efficient and reliable solution to detect infection in cases where the viral load is significant (Ct <30) and the person is likely to be contagious.
Covid19Check-SAL is not only painless and hassle free, but also has a sensitivity of 97.6% for Ct values up to 36 (the CDC suggests that when the Ct value is >33, the subject is not contagious anymore)

It is particularly useful in cases where frequent testing is required thanks to is simple, clean and pain free saliva sampling method.

The assay can be used as a bedside tool, in a laboratory, at a point of care or in a general practitioner’s office.
 
Covid19Check-NAS targets the N antigen protein and therefore detects the known variants of the Sars-Cov-2 virus: Lineage B.1.1.7 / 20I/501Y.V1 (UK variant), 484K.V2 (Brazilian variant), 501Y.V2 (South African variant), and B1.617 (Indian variant).
 
COVID19Check-SAL has been validated by the Belgian Health authority (AFMPS/FAGG): https://www.afmps.be/sites/default/files/content/Belgian%20validation.xlsx

Features & Benefits

Multi-G's Covid19Check-SAL Antigenic Rapid Test for COVID-19 is used to qualitatively detect SARS-CoV-2 virus in saliva samples.
 

Precise results

  • Sensitivity / PPA : 97.6%
  • Sensitivity day 1-5: 96.3%
  • Specificity / NPA : 99.1% 
  • Total coincidence rate : 98.7%

Quick & intuitive feedback

  • 15 minutes per test
  • Painless
  • Clean (no spitting, ni pipetting)
  • No training needed (vs nasopharyngeal)
  • Intuitive visual interpretation
  • No special equipment needed

How it works

The procedure is painless and hassle free compared to a nasopharyngeal test.

Results

A total of two detection lines are possible: one test line, which shows a positive result (even is the line is faint), and the control (C) line acting as a quality control procedure, showing that the sample has flowed through the cassette and the test has worked properly.

Negative

Positive

Positive

Both IgM & IgG positive

Performance

Multi-G's Covid19Check-SAL was evaluated in a broad clinical study with 712 samples, 165 positive and 547 negative. In that study, Multi-G's Covid19Check-SAL displayed a sensitivity of 97.6% (for Ct values <36), 96.3% for days 1-5 after onset of symptoms and a specificity of 99.1%.

Covid19Check-SAL is a very robust device, it shows no cross reaction with a large list of pathogens (H1N1 (new type A H1N1 influenza virus (2009), seasonal H1N1 influenza virus), H3N2, H5N1, H7N9, influenza B Yamagata, Victoria, respiratory syncytial virus, rhinovirus groups A, B, and C, adenovirus 1, Types 2, 3, 4, 5, 7, 55, enterovirus groups A, B, C, D, Epstein‐Barr virus, measles virus, human cytomegalovirus, rotavirus, norovirus, mumps virus, varicella‐band Herpes virus. No interference were found with 15 substances such as  Mucin, Hemoglobin, Histamine Hydrochloride , Human albumin , α‐ interferon , Lopinavir , Tobramycin, Ribavirin , Tramadol, Azithromycin, Meropenem, Oseltamivir, Benzocaine, Peramivir.
Covid19Check-SAL has been validated by the Belgian Health Agency: https://www.afmps.be/sites/default/files/content/Belgian%20validation.xlsx

Quality standards

In order to ensure the highest level of quality and reliability, Multi-G manufactures its test devices in Belgium, unlike most competitors who simply rebrand Asian made tests.

  • Multi-G's Covid19Check-SAL is compliant with the current CE-IVD regulations.
  • Multi-G's production facility in Antwerp, Belgium, is LQRA ISO 13485:2016 certified.
  • The production facility operates at the highest pharmaceutical standards.
  • Covid19Check-SAL is validated by the Belgian Health Agency (https://www.afmps.be/sites/default/files/content/Belgian%20validation.xlsx)

Applications

Multi-G's Covid19Check-SAL covers a range of applications. It allows you to speed up and scale up Covid-19 testing. It is an efficient solution to allow safe professional, business, educational and sports activities.
It is suited for a variety of settings such as companies, pharmacies, airports, schools, universities, sports premises etc.
It is meant for health professionals only. 
Registration as a self test is under way in several countries.

PCR labs

Reduce the workload of PCR labs, use PCR only to verify positive cases.

Cost reduction

Reduce the cost of testing : Ag Rapid test is on average 8 times cheaper than PCR.

Workplace security

Secure the workplace.

Public spaces

Secure public transports, schools, universities, events etc.

Private events

Screening participants to secure private events (weddings, conferences, exhibitions, etc).

Economic recovery

 Accelerate economic recovery by allowing eligible businesses to reopen with screening measures.

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Multi-G

Lange Leemstraat 166,
B-2018 Antwerpen
Belgium

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