How to tackle falsehoods and irregularities in PCR testing?

Wan Lixin
With a spate of high-profile problems relating to the quality of nucleic acid tests sparking social concerns, there is an urgent need to subject the sector to stricter supervision.
Wan Lixin

A spate of high-profile problems relating to the quality of nucleic acid tests has triggered social concerns, throwing into sharp focus the urgency of subjecting the sector to stricter supervision.

At a press conference of the Joint Preventive and Control Mechanism of the State Council, China's Cabinet, on November 29, it was revealed that this year, local authorities, in their supervision of nucleic acid testing providers, have uncovered a number of irregularities, including illegal problems.

All violators have been dealt with thoroughly, with some malfeasant testing entities or individuals being investigated in legal terms.

The press conference promised strengthened supervision of the service – or business, and serious violators, like those testing entities guilty of falsifying test results, would be dealt with to the letter of the law.

A recent commentary published by The Beijing News greeted such pronouncements as a positive signal at regulating a sector that has been a hot-button topic in public discussions over the past few days, and for good reason: As a critical step in monitoring and detecting cases of the COVID-19 contagion, the reliability of the tests would have a direct bearing on the accuracy and efficiency of the country's pandemic containment effort.

According to a recent report by the People's Daily, since the start of this year, at least 10 testing entities in seven regions across China have been warned, punished, or dealt with legally. In the wake of a nationwide inspection campaign in June and July, a total of 250 nucleic acid testing providers were told to go through rectifications, and 26 had to suspend providing their services, either voluntarily or compulsorily.

The importance of accurate polymerase chain reaction (PCR) testing cannot be overstated, and as such the threshold entry requirements have been strict. To say the least, a third-party nucleic acid test provider must meet relevant bio-lab requirements so that the lab can provide reliable results by amplifying genetic segments across several orders of magnitude.

It should come as no surprise that such providers also need to be certified by relevant administrative departments responsible for health and hygiene.

In spite of all these stringent requisites, recent reports have suggested sporadic cases of violations.

These violations seem to have been distinctly motivated. Some would mix up a number of different samples together and then have them tested in a lump sum, thus saving time and costs. Others would simply come up with false reports without actually conducting the tests.

Whatever their motivations, these irregularities would severely erode the reliability of test results, and seriously compromise the efficiency of the country's pandemic containment measures.

The commentary suggested that more effective deterrents must be in place to prevent such violations.

For instance, serious violators should be blacklisted and excluded once and for all from providing any testing services in the future. Those individuals directly responsible for such violations should also be handed over to the justice system.

Another message that should be heeded is that all PCR testing providers should be regulated and supervised on an equal footing, with all subject to the same degree of rigorous scrutiny. A spate of reports has suggested that some PCR test providers have expanded their test network explosively in recent months, gaining massive wealth and tremendous leverage, and are already busy with initial public offerings (IPOs).

Apparently, in view of the recent rising number of COVID-19 cases across the country, a zero-tolerance stance toward irregularities in PCR testing is a prerequisite for effective containment.

This stance is also critical for earning sincere cooperation and understanding from the people in general.

Special Reports