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SINGAPORE – Local medical technology company Cell ID has created a portable polymerase chain reaction (PCR) test kit that can confirm if someone has Covid-19 in five minutes.
CTO Xander Sim said those administering the test would not need specialized training or a lab to produce results.
The nasal swab test runs through an app on a laptop and requires less than two hours of training to operate.
However, the operator must be trained to take nasal swab samples.
“This way, when passengers arrive at an airport, you only need to hold them for a short time before you get a result,” Sim said Monday (Nov 30) at a press conference to announce the Quiz PCR Biochip test kit. . .
The “gold standard” for testing for Covid-19 is the PCR test.
However, PCR tests require highly specialized laboratories and technicians to run the tests, and liquid reagents that must be kept refrigerated.
It can also take days to return the results.
Increasingly, as Singapore seeks to reopen its economy further, it has turned to rapid antigen testing (ART), which can produce results in less than 30 minutes.
But ARTs have lower sensitivity and specificity and may carry a higher risk of false positives and false negatives.
Sim said the Cell ID PCR test can confirm a positive case in five minutes and a negative case in less than an hour.
“The goal was to develop a device that is accurate, without any compromise on the test result, but at a very affordable price … a test kit that someone from the third world can use as well,” added Mr. Sim.
The Quiz PCR Biochip has a sensitivity of 97% to 100% to Covid-19 and a specificity of 100%.
This is comparable to conventional PCR tests, unlike other rapid tests that are fast but have less specificity and sensitivity.
With the Quiz PCR Biochip, the nasal swab sample is first mixed into a solution.
A very small amount of the resulting mixture, 10 microliters, is then combined with another solution.
This ensures that the genetic signature of the virus is in high enough quantities for it to be detected.
The mixture is then placed in one of the two test wells of the Quiz PCR Biochip, which itself is smaller than a credit card.
The chip is then plugged into a special USB key, called a “Poche,” and plugged into a laptop for the test to begin. Results can be monitored in real time.
The genetic segments of the virus consume reagents in the solution as the virus multiplies, and it shows up as a drop on the graph displayed on the laptop screen.
Depending on the number of USB ports available, multiple tests can be run at the same time.
The chip is discarded after each test.
Trained in engineering
Sim, 56, spent more than three decades in the engineering and manufacturing fields before switching in 2013 to developing medical diagnostic tools, despite having no background in biology.
Invented Quiz PCR Biochip in 2015 and it was originally used for HIV testing in 2018.
Sim said he had to endure years of failed prototypes, which also saw him suffer two strokes. It left him temporarily blind and with a weak left leg.
“(I told God) I don’t need to live 100 years, just give me a little more time so I can finish my work and my mission,” Sim recalled at a press conference Monday.
In April, in the middle of the circuit breaker, Cell ID developed a reagent that allowed it to be used to test Covid-19.
Sim said it is difficult to predict how much testing will cost when using the Cell ID chip, as it would depend on factors such as overhead costs incurred by the testing agency.
He said it currently costs less than US $ 50 (S $ 67) to produce one of the chips, but this is expected to decrease with economies of scale.
Tested in bedrooms
The PCR Biochip Quiz was tested in dorm S11 and at the Expo Community Care Center earlier this year, in collaboration with staff from Sengkang General Hospital and Woodlands Health Campus.
Of the 215 people who were tested with the chips, 27 positive cases were detected.
Sim recalled: “The first result was positive in seven minutes. We were overwhelmed.”
He said that everyone at the command center was surprised that an accurate Covid-19 test could be performed on the site.
“I almost cried,” he added.
The tests were also verified at an external laboratory in Switzerland in November, where it was found that the biochip could detect coronavirus equally well in saliva samples and nasal swabs.
Sim said he is excited about this, as saliva tests are faster and require less equipment than nasal swab tests.
They are also not that uncomfortable for the patient.
It is currently awaiting regulatory approval from authorities, such as the United States Food and Drug Administration and the Singapore Health Sciences Authority, for the kit to be used.
Mr Sim said: “My hope is that the test can be implemented globally and that it will be useful in helping countries safely open up again.
“That is my greatest hope.”
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