Swazi Observer

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ESTABLISHING A LEVEL 4 BIOSAFETY MOLECULAR LABORATORY (COVID-19)

By Bongisipho Shabangu and melusi mthembu | 2020-04-09

AFTER assessing the risk of spread and risk of impact of coronavirus (COVID-19), International Health Regulations (IHR) experts advised World Health Organization (WHO) that the risk was very high at the global level.

Then on January 30, WHO Director General Dr Tedros Adhanom Ghebreyesus declared the COVID-19 outbreak a public health emergency of international concern (PHEIC) under the International Health Regulations (IHR 2005).

In same declaration message, WHO advised each country to start preparing for the imminent outbreak by establishing access to a competent laboratory which will function to screen, diagnose monitor therapy and conduct active surveillance of COVID-19 outbreak

We commend the ministry of health for coming up with the Eswatini National Contingency Response Plan to COVID-19.

However, we have analysed this plan with respect to laboratory capacity to manage large-scale testing for COVID-19 either domestically, or through arrangements with international reference laboratories.

From quarantine, we humbly advise our highly esteemed authorities to quickly start exploring and investing more in the local only option.

COVID-19 testing capacity should exist at national level, few samples should be sent to a regional or international reference laboratory only for quality assurance purposes.

We are saying this because in the event of widespread community transmission, local systems will be activated to manage the increased volume of samples from suspected cases, and local WHO office will need to be consulted to provide support to access relevant trainings, protocols, reagents, and supplies including rapid collection and testing of appropriate specimens from suspected cases.

We are pretty aware that the economic situation of our country, in view of that, well trained volunteers such as medical laboratory scientists like us are needed to boost capabilities on collecting potentially infectious specimens and performing highly specialised laboratory analysis of COVID-19 in level 4 biosafety molecular laboratory. Our own COVID-19 laboratory will ensure testing is timely and reliable.

In the absence of in-house laboratory service, access to timely screening, reliable diagnosis, COVID-19 resistance and vaccine immunogenicity characterisation is less likely to be ensured.

We also understand that, under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorised as waived (from routine regulatory oversight) or non-waived based on the complexity of the tests; tests of moderate and high complexity are non-waived tests.

Laboratories that perform molecular genetic testing are subject to the general CLIA quality systems requirements for non-waived testing and the CLIA personnel requirements for tests of high complexity.

Although many laboratories that perform molecular genetic testing comply with applicable regulatory requirements and adhere to professional practice guidelines, specific guidelines for quality assurance are needed to ensure the quality of test performance of COVID-19.

Testing

To enhance the oversight of genetic testing under the CLIA framework, Centre for Disease Control (CDC) has taken practical steps to address the quality management concerns in molecular genetic testing, including working with the Clinical Laboratory Improvement Advisory Committee (CLIAC).

Hence, we know that establishing a level 4 biosafety molecular laboratory for COVID-19 needs to meet CLIAC recommendations for good laboratory practices for ensuring the quality of molecular genetic testing for heritable diseases and conditions.

The CLIAC recommendations for good laboratory practices address the total testing process (including the pre-analytic, analytic, and post analytic phases), laboratory responsibilities regarding authorised persons, confidentiality of patient information, personnel competency, considerations before introducing molecular genetic testing or offering new molecular genetic tests, and the quality management system approach to molecular genetic testing.

Recommendations

These recommendations are intended for laboratories that perform molecular genetic testing for heritable diseases and conditions and for medical and public health professionals who evaluate laboratory practices and policies to improve the quality of molecular genetic laboratory services.

As local medical laboratory scientists (MLS), we have a feeling that establishing a state-of-the-art COVID-19 Molecular Laboratory right here in Eswatini should not have taken ages.

We are proud Emaswati, locally brewed scientists, and so determined and motivated to defend our nation against COVID-19 given the right opportunity to do so. We also see COVID-19 not as a threat, with appropriate level of investments, COVID-19 can be our only stepping-stone to achieve His Majesty’s vision 2022 in molecular and quantum biology research.

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