The outbreak and rapid spread of the ‘Wuhan virus’ otherwise named by WHO as COVID-19 virus, across the globe was unprecedented and has caused, and continue to cause enormous public health and economic crisis. Most worrisome is the fact that notwithstanding a nation’s status whether high, medium and low – income countries, the rapid spread overwhelmed and over stretched each of their health systems and even their economies.
Notwithstanding, the WHO was able to coordinate and provide guidance to many countries to be able to directly take actions in the control and management of this novel virus pandemic. According to the Director-General of the WHO, Dr Tedros Adhanom Ghebreyesus, the pandemic can only adequately be tamed, managed and controlled by increased medical laboratory testing. The reason is obvious. The doctors and nurses can only administer treatment to those identified and confirmed as tested positive to the virus. It is just visible by mere observation and guess work.
The health systems particularly the medical laboratories, biomedical manufacturing communities and the professionals and scientists responded quickly to the challenges with technical processes by developing covid-19 diagnostic tests through the launch of the highly complex Polymerase Chain Reaction (PCR) viral based tests. Manufacturers rose to the challenges by coming up with the development and set up to increase workflow, the lack of awareness by Clinicians, shortage of medical laboratory staff, reagents and other supplies at the onset notwithstanding.
Using the U.S as point of reference, at the onset of the Covid-19 pandemic outbreak, the health systems earlier taunted as advanced was faced with major problems in terms of lacking in facilities and capacities for testing. Only the PCR testing systems are available in the CDC and the several public health laboratories all over the country. This is partly similar to the situation in Nigeria where only five PCR testing systems were available in NCDC and few Federal Medical Centres are up and running. Regrettably, no state had functional public health laboratory and infectious disease centres except perhaps the Lagos State IDH at Yaba. The struggle and urgency to set up PCR testing labs led to the large commercial biomedical manufacturing companies with reliable PCR testing system as early support but unfortunately Nigeria has no such support because of the death of biomedical manufacturing companies. The manufacturing companies in China, U.S and Europe were found handicapped with production thus compelling the U.S FDA to adopt the policy of EUA – Emergency Use Authorization, whereby non-FDA validated but companies validated reports was considered for approval and permission for testing kits to be deployed for covid-19 analysis. In addition, as required under the quality assurance standards of each testing laboratories to validate assay kits before use, they rose up to the challenge. In the U.S for Instance there arose a time where a testing laboratory received an EUA PCR kits and had her ‘staff validate them over the weekend and before running them the following Monday’ according to Dr. Maria E Aguero-Rosenfield who is the Director of Clinical Labs, New York University (NYU) Lagoona Health in New York City, U.S.
While testing with PCR systems were ongoing, validation and verification of serology(antibody) testing kits were being undertaken. Out of over 180 commercially available serological test kits, only 10kits were finally available for full scale verification but according to Dr. Elitza Theel of the Infectious Diseases Lab, Mayo Clinics in Rochester, Minnesota, U.S, these kits “did not perform equally well”. The foregoing is to show the seriousness attached to ensuring that quality and reliable results are obtained in testing the population and truly ascertaining the actual persons infected by the COVID -19 pandemic.
Due to the unique nature of the infectious characteristics of COVID-19 and being a novel coronavirus, many testing labs were required to create separate testing space with adequate standard safety capacities. Apart from creating this space, the labs were unfortunately faced with shortage of Medical Laboratory Sciences Professionals and the need to ensure physical distancing safety measures as demanded by covid-19 prevention regulations. Many Medical laboratories in the U.S, therefore resorted to working out a double or triple shifting process over a 24-hr operation. There is equally the urgency to train and re-train the Medical Laboratory Scientists who are duty bound to conduct the testings. Unlike in the U.S, Nigeria do have the advantage of having some Medical Laboratory Scientists(MLS) in the Universities, Research Institutes in addition to those in the employment of Federal and State health institutions who were or could be mobilized and deployed in the face of obvious shortages of MLS and the mountain of challenges in testing facilities and limited capacities associated therein. There was equally the report of shortages of reagents because many biomedical companies closed shop. Shortages of reagents, collection swabs, transport media and testing kits was a major problem even by the industrial nations. The problem is made worse in developing countries particularly Nigeria where there just no company manufacturing common swabs or transport media not to talk of COVID-19 testing kits and PPE materials. Indeed, the Director General of the Nigeria Centre for Disease Control (NCDC) was reported to have lamented and expressed regret about these acute shortages of testing materials while declaring an open bidding process for supplies. According to him, this lack of testing reagents is responsible for the very low testing capacities of the molecular testing medical laboratories and the attendant very low level of declared confirmed covid-19 cases.
The indicators for obtaining a true positive and confirmed case for covid-19 infection must ensure verifiable clinical sensitivity and specificity of the testing systems. In normal situations, these indicators vary by population, severity of disease and collection methods. It’s noteworthy that proper collection method of specimens and its preservation before testing is very paramount in medical laboratory testing. Kudos must be given to the NCDC for their insistence on the use of RT-PCR testing technique and the use of MLS professionals who are primarily better trained in understanding the drawbacks of pre-analytical processes like the collection of laboratory specimens and quality preservations and then ensuring standard and professional testing techniques.
COVID-19 has very unique and significant peculiarities associated to its detection. Novel coronavirus is detected easily in the early stages of the disease and becomes less detectable as illness progresses, viral load decreases and severe complications appears. This means that a patient with the most observable respiratory symptoms to covid-19 may turn out a negative result. For this reason, we need testing kits with a much higher sensitivity ratio which best reflects the limit of detection. The use of serological testing kits at this moment is not out of place but it is only valuable in testing frontline healthcare staff for exposures or those who already are manifesting later stage symptoms but cannot be detected by PCR. However, these kits cannot give information about the level of duration of protective immunity or whether the individual is still infectious. To be able to meet some standard clinical criteria, the U.S FDA on manufacturers of antibody testing kits requesting for Emergency Use Authorisation (EUA) to set forth their clinical performance characteristics like 90% sensitivity and 95% specificity.
Regrettably, the situation in Nigeria is just unthinkable as individuals and groups of some professionals are determined not to allow proper validation and verification of testing kits before use all to oil their ego of self-leadership. It’s also interesting to note how some business people, masquerading as clinical interest groups —who lack formal understanding of reagent validations in clinical laboratory sciences and who are ever ready to seize any opportunity to represent dubious manufacturers and vendors to sell unvalidated and unverified testing kits for economic gains to the detriment of public safety. They are determined to sabotage the statutory requirements and undermine the laws of the land which aims to safeguard the health of the public. We recall vividly how a covid-19 testing kit manufactured by a Chinese (Shenzhen) diagnostic company -Bioeasy was found to be only 30% accurate after evaluation by Spanish authorities and discontinued for use. We agree that the outbreak of covid-19 has caught many nations napping and unprepared in the face of undermining the establishment of medical laboratory testing infrastructures in our public health establishments.
Notwithstanding the inadequacies that bedeviled our society with the presence of covid-19 pandemic and the shortcomings discussed above, observations and lessons must have been noted and learnt moving forward. What is required of all government agencies including the executive and legislative and regulatory professional bodies like MLSCN, MDCN, NAFDAC, is the need to prepare for widespread infectious disease outbreaks going forward. We must urgently work to establish functional public health laboratories by the different states and the Federal governments that will continually investigate and thus mitigate any disease outbreaks both communicable and non-communicable ones. These Medical laboratories will no doubt deepen the diagnostic scope of medical practices indirectly by the development of laboratory developed tests (LDTs) amongst others.
Indeed, the highly respected medical journal – Lancet in a recent well thought editorial and published articles strongly identified and recommended this position just a year ago before the covid-19 pandemic outbreak saying “access to quality-assured laboratory diagnosis has been a challenge in low-income and middle-income countries (LMICs) resulting in delayed or inaccurate diagnosis and ineffective treatment with consequences for patient safety”. Proper standard and qualitatively validated and verified testing kits/reagents as is being vigorously carried out by the Medical Laboratory Science Council of Nigeria (MLSCN) and equipment supply chains must be established even in emergencies. Ultimately, this must dovetail into encouraging the establishment of medical technology manufacturing companies through very friendly, conducive, deliberate and favourable economic climate in the nearest future. Commendably, the Nigerian Central Bank (CBN) recently after the covid-19 pandemic outbreak and the subsequent lockdown, initiated a N50b soft loan programme towards this direction. In addition, the MLSCN which is the statutory government body empowered in the validation, verification of diagnostic reagents/kit produced locally or imported in the country by virtue of Act 11, 2003(LFRN) and working in professional collaboration with NAFDAC and NCDC and even the U.s CDC, must be duly mandated and mobilized to undertake this onerous task diligently and efficiently for the glory and safety of the health of Nigerian in particular and the global health community in general without let or hindrance on the altar of petty ego by any group of professionals whatsoever. It is only through this way can we guarantee quality diagnostic results knowing fully that global medical practice is more than 70% dependent on quality medical laboratory results/reports.
There must also be a deliberate policy of government -both the executives and the legislatures, to train and retrain all cadres of healthcare professionals. In a way of motivating them to thereafter play useful roles, all health professionals must be considered and included in relevant advisory, control and board managements, whether adhoc or not, in any public health agencies. There must equally be respectful collaboration between medical laboratory practitioners and among other health professionals especially in the development of new methods and tests to control and prevent outbreaks in future.
The outbreak of covid-19 pandemic has equally brought to reality though regrettably, the absolute necessity to always observe safe and standard measures that will not expose health workers to unnecessary risks and hazards that ultimately lead to disabilities and death to practitioners. We are trained and reminded at all times to take precautionary measures while attending to any patients. It is however sad that during the pandemic, many healthcare professionals were infected and eventually died or suffered some disabilities. We are not oblivious of the fact also that many governments abysmally failed to provide safety gadgets like gloves, PPEs and N95 face masks etc. We thank the Almighty God that made it possible for many that were infected to survive. Its been a great challenge to everyone and an eye opener to many of us as frontline professionals and government policy administrators.
Article was written in furtherance of public health education by
Dr. Ejetavwo George – An academic Scientist with the Delta State University, Abraka.
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