Consequences of using poor quality PCR test kits, and misinterpretation of data

By Sunil J. Wimalawansa,

Professor of Medicine

From March 2020, the current administration had multiple golden opportunities to prevent and better manage COVID-19 in Sri Lanka. Several learned Sri Lankans with expertise, including the author, suggested different options: the administration rejected them and opted for curfew. If strategic, proactive preventative actions, as suggested by the author, were implemented in March/April 2020, it could have prevented the community spread of COVID-19, without resorting to the ineffective and draconian curfews that caused the loss of livelihoods and despair, and ruined the economy.

Why ARE PCR testing kits failing?

The currently used PCR test kits in some countries including Sri Lanka, especially the cheaper kits sold or donated by China, are of inferior quality, and therefore the resulting data is unreliable. These test kits are less sensitive and less specific. So, the results can be misleading. This creates an serious injustice, labelling people who are not COVID-19 infected as ‘patients’ (false positive; similar to falsely labelling people as HIV positive) and the failure to diagnose those who are infected (false negative), both creating bad situations that eroded the trust of people.

Concerns related to PCR data:

Just because a PCR test is positive, it does not necessarily mean that the person is infectious or infected with COVID-19. The PCR test only detects a small viral fragment, and thus a positive test does not confirm that the person is having the virus or he/she is infectious. Besides inferior quality products, there are other scientific reasons why PCR test kits fail. Some of the common reasons are (1) faulty diagnosis (technological issues, including over-amplification of PCR cycles than recommended), (2) contamination and/or sample mixed-up, (3) previous infections with other coronaviruses, (4) patients’ recovery from COVID-19 infection irrespective of symptomatic or asymptomatic, and (5) maintaining the positivity, after full recovery (incidental detection of viral particles that yet have not been eliminated).

Similarly, a person found negative for PCR (e. g. false-negative results or during the early incubation period), can become positive in a few days. PCR is not the gold standard for diagnosing COVID-19, and new methods are emerging to overcome this issue. Importantly, the PCR test does not confirm that a person is having an active COVID-19 infection.

Lack of transparency and PCR scandals:

In most cases, the military runs the quarantine centres like ‘prisons’, detaining people without their consent. It was reported that some were kept extra days in hotels (apparently not in free quarantine centres) due to a delay in getting a second PCR test results. Such actions forced persons to pay for the extended stay and PCR testing by the private sector, for no fault of theirs, before being allowed to go home

The actual cost of a PCR test is a fraction of what private hospitals are charging and claimed by the Health Department. The ongoing trend suggests that the COVID-19 tragic situation has been turned into a lucrative business by some unscrupulous people. Making it mandatory for companies to have PCR tests done at private hospitals is an example.

Who should conduct PCR testing?

It is commonsense that the Health Department should carry out such testing as a part of COVID-19 public health management and proactive surveillance programme. It is unethical to place an additional burden on businesses that are already struggling to survive due to the mismanagement of the COVID-19 transmission and the resultant economic crisis.

Most of the delays in receiving PCR test results are apparently due to administrative and logistical failures, and a few have been attributed to dysfunctional PCR testing equipment. Nevertheless, responsibility comes with accountability. Since the army claims to be fully responsible for managing the quarantine centres, they are not only accountable but also have ethical and fiduciary responsibilities for obtaining the PCR test results without delay and releasing people they are holding. If there are any additional costs to people resulting from delays, the army must bear that.

Wrongly labelling people with COVID unethical:

It is unfair to label people as having COVID-19 wrongly; senior health administrators must take full responsibility for this. They must understand and acknowledge their limitations, and take affirmative steps to prevent it. They have not done so. When they are unsure, they should repeat the PCR and say “possible or probable” PCR positive, but no one can guarantee a person is infectious. As per the law of the country, getting unintentionally infected with COVID-19 is not a crime: it is just like getting the common cold or a heart attack. Then why are PCR positive innocent persons treated like criminals? It is time to change the stigmatizing attitude of anti-COVID task force and the law enforcement authorities towards the PCR positive persons: they are also our fellow citizens.

Presidential action needed:

The President should instruct the law-enforcement agencies immediately to stop harassing people who might have been exposed to the virus, and locking up those who are found PCR positive, their families and neighbours for 14 days. This amounts to discrimination. If the President or a current government minister is found to be a COVID-19 contact or becomes PCR positive, will they also be locked up in a quarantine centre? Law must apply to everyone equally.

Inhumane treatment of people continues:

Contact tracing and quarantining, in Sri Lanka in particular, are being implemented in an inhumane and punitive manner. Those engaged in such practices are violating the laws of Sri Lanka (e. g. harassment and/or unlawful arrests). Sri Lankans do not deserve such treatment.

1897, Quarantine & Prevention of Diseases Ordinance (with a few amendments) in Sri Lanka does not authorise law-enforcement officers forceful detention—arresting and imprisoning people—or intimidating, harassing, and harming citizens, in the absence of a crime. Such actions are unfortunately taken for granted though illegal. Those who are engaged in them may think they have immunity, but they can be held liable.

Community spread is not a myth:

Despite denials, Sri Lanka has had community COVID-19 spread since April 2020. In recent days, when the daily PCR testing is increased to more than twenty-fold (see below), it was not surprising to see an increased number of PCR positivity. With the presence of community spread, increased PCR positivity detected is proportionate to the number of PCR tests conducted. For example, if the Health Department had carried out PCR testing in the community from May through August 2020, as the author and others have urged it to do since April 2020, it would have detected 10-40 times the number of PCR positive cases in the community it has reported to the World Health Organization (WHO). Therefore, the incidence and prevalence of COVID-19 reported to the WHO was misleading and grossly underestimated.

The Rate of PCR positivity has not changed significantly

The ‘rate’ of PCR positivity (the number of PCR positive persons divided by the number of PCR tests carried out), has not changed significantly from May/June to October/November. The detection rate has only changed from 2% to 3%. This 1% change was fully accounted for by the twenty-fold increase in the numbers of PCR testes on “high-risk” groups that began in mid-October. It was not due to an exponential dissemination of COVID-19.

Therefore, contrary to the claims by spokespersons for the COVID task force and the Health Department, there was no new COVID crisis in October. The crisis was self-created because of misunderstanding and misinterpretation of the PCR data. The resulting curfew in late October was another major mistake that further harmed the country and its economy. The Sri Lankan government was misled to authorise an inappropriate curfew yet again in October: this time around, due to the misinterpretation of PCR data and the inability to understand basic statistics. This is unfortunate for Sri Lankans.