BATM, a provider of real-time technologies for networking solutions and medical laboratory systems, has launched a new molecular diagnostics kit that uses self-collected saliva samples to test for SARS-CoV-2 (COVID-19). 

This significantly improves the sample collection process compared with existing swabbing methods while, as an RT-PCR test, maintaining diagnostic accuracy. The group has commenced taking orders and expects to begin delivering the kit in April. 

This new kit, which is part of Adaltis’ MOLgen product range, consists of reagents that have been developed to detect SARS-CoV-2 in saliva samples that are collected by an individual chewing a cotton ball for 30 seconds and then spitting it (or spitting directly) into a small plastic collector tube (a Salivette). It uses the RT-PCR technique, which ensures the highest levels of diagnostic accuracy compared with other saliva-based tests currently available in the market that primarily use the lateral flow method, which are far less accurate causing many false negatives and positives.

The reagents are based on the group’s existing COVID-19 antigen kit that tests samples collected via swabbing the upper (via the nose) and middle parts of the throat or fluid from the lungs, and which has five (4+1) gene discovery capability (compared with most kits on the market having three gene discovery capability or less) to enable detection even with a very low viral load. The new test has 100% accuracy for both specificity and sensitivity.

By the individual collecting a saliva sample, the test can be administered without the need for any trained healthcare workers in full body personal protective equipment. The test also has the advantage of being non-invasive and comfortable compared with swabbing via the nose (nasopharyngeal swab) or back of the throat (oropharyngeal swab). As a result, it is a far simpler and quicker solution, and has particular benefits for testing children and people with disabilities where the existing swabbing methods can cause distress or the tests are not possible to administer at all. 

Other benefits of the new test include:

• Processing times at the laboratory are significantly reduced as the RNA extraction phase that is required for the existing swabbing methods before putting the samples into the PCR instrument is not needed for the Group’s saliva-based test (which operates under a protocol developed at Yale University). The RNA extraction phase is also expensive and the main cause of contaminations that result in false diagnoses.   
• All standard PCR instruments can execute this test at a rate of c. 150-180 per hour, which (including the extraction phase) is approximately five times the rate for a nasopharyngeal test. One person is able to operate several instruments at the same time, which is very difficult with tests based on the existing swabbing methods. In addition, the instruments are able to be transported and set up in a mobile location. As a result, one operator can manage in excess of 1,000 tests per hour and can be deployed to where needed, such as the site of a school, sports event or on a cruise ship.
• It negates the risk of false negatives that can arise due to a badly performed nasopharyngeal swab.

This new kit, which is CE certified, is able to detect all known variants of COVID-19, including in people who are asymptomatic. It has been validated by leading research and medical institutions in Italy.

The test can be processed using Adaltis’ AMPLilab instrument or any standard PCR instrument. The Group can also provide the sample collectors. 

Dr Zvi Marom, CEO of BATM, said: “We are extremely proud to have launched this new saliva-based COVID-19 test for samples that are self-collected without the need for swabbing. This greatly simplifies the testing process to increase speed and reduce cost while maintaining the same high level of diagnostic accuracy. Despite the excellent progress that has been made with vaccinations, we believe that COVID-19 will be with us for quite some time and so solutions such as our new saliva test will be invaluable for providing the ongoing testing required in places where people gather such as schools and leisure venues. We have already received particular interest from cruise lines and professional sports teams who see this test as enabling a safe return to more normal life. We look forward to commence shipping this product shortly and to delivering further innovative diagnostic solutions for COVID-19 and other infectious diseases in the near future.”