Todos Medical and its joint venture partner NLC Pharma have reported positive clinical validation data from a study where the former’s SARS-CoV-2 3CL protease biomarker assay, TolloTest, demonstrated complete sensitivity in detecting vaccinated asymptomatic Covid-19 patients.
The study assessed the sensitivity of the test against polymerase chain reaction (PCR) tests in Covid-19 patients admitted to the hospital.
Patients in hospital for conditions other than Covid-19, those who were exposed to SARS-CoV-2 in the community outpatient setting and healthy subjects were also included in the study.
The study enrolled 58 hospitalised subjects and research staff, with 30 of them having negative PCR results and 28 having positive results.
Data showed that 12 out of the 30 subjects without Covid-19 were found to be positive by TolloTest.
Todos noted that these subjects could have had exposure to the virus or were infected with another coronavirus such as a common cold.
Meanwhile, 25 of the 28 patients with positive PCR results had a positive report with TolloTest.
The three remaining subjects in this group who tested negative with TolloTest had PCR cycle time values (ct values) of 30 or more, signifying that they were nearing or at the end of the viral disease process and were less prone to be infectious.
The findings demonstrated a steady inverse link between ct value and 3CL protease activity in hospitalised as well as non-hospitalised patients.
In addition, 17 completely vaccinated subjects were enrolled in the study from a community event setting with exposure to the SARS-CoV-2 virus.
Of these subjects, 16 were tested positive for Covid-19 by PCR and one was negative.
TolloTest showed that these 16 patients were positive while identifying the PCR-negative subject as negative.
The company noted that the TolloTest worked flawlessly, demonstrating a sensitivity and specificity of 100%.
The latest data from the study established the sensitivity of the test against PCR-confirmed positive Covid-19 results in the hospital as well as outpatient setting.
Furthermore, the data offered vital insights on the 3CL protease biomarker’s potential role in evaluating the Covid-19 infectivity status of infected patients who are released from quarantine.
It also aids in opening the diagnostic window to include quicker diagnosis of people from the time of exposure to the virus.
Todos estimates that the 3CL protease biomarker can be used for multiple purposes, including as an adjunct for Covid-19 PCR or antigen testing.
Todos Medical chief scientific officer Jorge Leon said: “Neither PCR or antigen tests have the ability to measure infectivity.
“Additionally, it appears the 3CL protease biomarker assay may open the diagnostic window to more accurately reflect the initial presence of SARS-CoV-2, as well as a more accurate measure of when a person is no longer infectious post-diagnosis than mandatory seven-, 10- or 14-day quarantine measures.
“The length of quarantine should be driven by infectivity biomarkers, not by relatively arbitrary estimates of how long infectivity may last.”
In September last year, Todos announced the commercial launch of its TODOS 2019-nCoV RT-qPCR Detection Kit in the US.