Advanced MedTech Holdings (AMTH), a global medical technology leader headquartered in Singapore, announced today that the RESOLUTE 2.0 test kit has become the first RT-PCR COVID-19 test to be authorised by Singapore’s Health Sciences Authority (HSA) for deep-throat saliva (DTS) SARS-CoV-2 testing. 

The clinical performance of DTS is supported by clinical studies involving the Diagnostics Development (DxD) Hub hosted by the Agency for Science, Technology and Research (A*STAR); Temasek Foundation; Sheares Healthcare Group (SHG); Changi General Hospital (CGH); DSO National Laboratories (DSO); and Woodlands Health Campus (WHC). The tests conducted on DTS specimens were able to accurately identify all the known positive cases in the clinical studies.

Using DTS, specimen collection is much less invasive and more comfortable for patients than current collection through swabs inserted into the back of the nose or throat. DTS collection only requires patients to draw out saliva from deep within their throat and spit into a specimen bottle. This makes it easy-to-administer and allows patients to conduct the collection themselves without the supervision of medical professionals, therefore mitigating the risks of potential virus spread as well.

RESOLUTE 2.0, eliminates the need for extraction of viral RNA from patient test samples and minimises potential human errors while cutting down test delivery time by half when compared to other approved RT-PCR tests. The test kit will be administered at a new COVID-19 testing lab that will open in Changi Airport in 2021 and speed up current testing capabilities and increase output samples to more than four times the output capacity of a lab using conventional RT-PCR tests. It is an industry-first direct multiplex RT-PCR COVID-19 test kit co-developed by A*STAR and DSO National Laboratories, manufactured and distributed by AMTH.

Although there have been a number of reports and studies relating to the use of DTS specimen, most involved the off-label use of assays. This could be one reason for inconsistencies in the performance of DTS as a specimen. Saliva testing by RESOLUTE 2.0 was authorised based on a standardised DTS collection and assay workflow, which would ensure the consistency and accuracy of the performance. 

Abel Ang, Group Chief Executive of Advanced MedTech, said: “ Having a fast, painless, and accurate COVID-19 test kit like RESOLUTE 2.0 is a game changer for Singapore as we reopen our borders, revive our conventions, and rebuild the air hub status of Changi Airport.” 

Associate Professor Ng Wai Hoe, Chief Executive Officer, Changi General Hospital, said: “The kit offers an additional option and flexibility for COVID-19 testing in the community to suit screening and diagnostic requirements. Besides superior comfort and ease of use, it serves to reduce the exposure risk for swabbers and other healthcare workers during sample collection."