Laboratory medicine resilience during coronavirus disease 2019 (Covid-19) pandemic

Resiliência dos laboratórios clínicos durante a pandemia de coronavírus 2019 (Covid-19)

Giuseppe Lippi1; Mario Plebani2

1. L’azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy
2. Policlinico Universitario (Azienda Ospedaliera di Padova), Padua, Italy

Corresponding author

Giuseppe Lippi
ORCID 0000-0001-9523-9054
e-mail: giuseppe.lippi@univr.it

Mario Plebani
ORCID 0000-0002-0270-1711
e-mail: mario.plebani@unipd.it

Published on 4/21/2020

This article was originally published in Advances in Laboratory Medicine/Avances en Medicina de Laboratorio as ahead of print.

In vitro diagnostic testing has been a virtually innocent target of heavy, reiterated, often irrational cost-containment polices during the past decades, which have contributed to diminishing the availability of technical and human resources all around the world(1). Although working close to the “minimal level of survival” has hence become commonplace in the vast majority of laboratory services(2), the coronavirus disease 2019 (Covid-19) pandemic has triggered an unexpected and unprecedented universal crisis, which has rapidly overwhelmed the responsive capacity of the entire system of health care, thus also including laboratory diagnostics(3). The last report of the World Health Organization (WHO) emphasizes that Covid-19 has already affected more than 1 million individuals around the world, causing over 50,000 deaths(4). The epidemiological figures in some Countries like Spain and Italy are especially alarming, whereby the number of affected people has rapidly grown over 100,000, with mortality rates as high as 8%-11%(4), thus closely reflecting that of the previous severe acute respiratory syndrome (SARS) outbreak, caused by an analogous coronavirus(1). Even more importantly, nearly 20% of all Covid-19 cases require hospitalization for either sub-intensive or intensive care, thus posing an additional burden to clinical laboratories, which are forced to produce a large volume of critical (i.e., urgent) tests results, with the shortest possible turnaround time(6).

In this “perfect storm” scenario, laboratory medicine is once more demonstrating its inherent and well-known resilience, whereby laboratory professionals are uninterruptedly providing vital test results for diagnosing, prognosticating and managing patients with Covid-19. Several lines of evidence contribute to demonstrating that the etiological diagnosis of SARS-CoV-2 infection (i.e., the coronavirus responsible for Covid-19), will not be possible without laboratory testing, either by directly identifying the presence of the virus in biological samples with (real-time) reverse transcriptase-polymerase chain reaction (RT-PCR), or through detection of immunological response against the virus by monitoring antibody response(3). Albeit the diagnostic accuracy of RT-PCR on oropharyngeal and nasopharyngeal swabs, and serological testing in serum or plasma used alone is suboptimal, especially within one week from symptom onset (i.e., 67% and 38%, respectively), the combination of these two diagnostic techniques may consistently enhance the sensitivity of laboratory diagnosis up to 80%-90%(7). Between eight to 14 days after the onset of the symptoms, the combined sensitivity of viral ribonucleic acid (RNA) identification and antibodies detection increases up to 97%, thus plenty satisfying optimal diagnostic criteria.

Beside the essential, virtually unavoidable, contribution to diagnosing SARS-CoV-2 infection, laboratory medicine is then essential for risk stratification, whereby many tests such as the complete blood cell count, inflammatory, cardiac, muscle, liver, kidney and hemostasis biomarkers, are essential elements for identifying a subset of patients at enhanced risk of developing the most severe Covid-19 complications such as acute respiratory distress syndrome (ARDS), severe inflammatory response syndrome (SIRS), targeted and multiple organ failure (MOF), up to death(8).

At this point in time, it cannot be denied, either by policymakers or hospital administrators, that that Covid-19 outbreak has placed a formidable strain on a health care sector already close to a chasm. Although neither using a crystal ball we will be able to predict if, nor when and how, this unprecedented pandemic will terminate, some lessons must be learned. The local response of laboratory medicine services to the Covid-19 outbreak has been always efficient all around the world, despite the many and reiterated cuts. All professional figures working in clinical laboratories staff shall hence be gloried and prized for providing such an efficient support. Nonetheless, ordinary working with minimally sufficient resources has obligated to urgent recruitment of personnel, often with rapid selections, as well as to the need of purchasing additional instrumentation to meet the increased volume of testing, especially in certain areas of the laboratory such as molecular biology and serology. Shortage of some reagents, due to impossibility to stockpile (for limiting contingent hospital costs) or inability of supply importers to fulfill the demand, has further amplified the vulnerability of this sector. Last but not least, the incessant consolidation of small laboratories into larger facilities has contributed to amplify the diagnostic delay, and hence derange the clinical decision making in many worldwide areas(9).

Therefore, we conclude here reporting the foremost and celebrated Latin mantra “herrare humanum est, perseverare autem diabolicum“, in the most sincere wish that everybody will learn from this exceptional tragedy.

RESEARCH FUNDING

None declared.

AUTHOR CONTRIBUTIONS

All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

COMPETING INTERESTS

Authors state no conflict of interest.

REFERENCES

1. Lippi G, Plebani M. The add value of laboratory diagnostics: the many reasons why decision-makers should actually care. J Lab Precis Med. 2017; 2: 100. Available at: https://doi.org/10.21037/jlpm.2017.12.07. Google Scholar Crossref Export Citation.

2. Lippi G, Plebani M. Cost, profitability and value of laboratory diagnostics: in God we trust, all others bring data. J Lab Med. 2019; 43: 1-3. Available at: https://doi.org/10.1515/labmed-2018-0321.Google Scholar Crossref Export Citation.

3. Lippi G, Plebani M. The critical role of laboratory medicine during coronavirus disease 2019 (Covid-19) and other viral outbreaks. Clin Chem Lab Med. 2020. Available at: https://doi.org/10.1515/cclm-2020-0240. [Epub ahead of print]. Google Scholar.

4. World Health Organization. Novel Coronavirus (2019-nCoV) situation reports. Available at: https://www.who.int/emergencies/diseases/novelcoronavirus-2019/situation-reports. Last accessed, April XX, 2020.Google Scholar.

5. Lippi G, Sanchis-Gomar F, Henry BM. Coronavirus disease 2019 (COVID-19): the portrait of a perfect storm. Ann Transl Med. 2020. Available at: https://doi.org/10.21037/atm.2020.03.157.Google Scholar.

6. Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020. Available at: https://doi.org/10.1515/cclm-2020-0198. [Epub ahead of print]. Google Scholar.

7. Zhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020. pii:ciaa344. Available at: https://doi.org/10.1093/cid/ciaa344. [Epub ahead of print]. Google Scholar.

8. Henry BM, Santos de Oliveira MH, Benoit S, Plebani M, Lippi G. Hematologic, biochemical, and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis. Clin Chem Lab Med. 2020. Available at: https://doi.org/10.1515/cclm-2020-0369. Google Scholar PubMed Export Citation.

9. Plebani M, Laposata M, Lippi G. A manifesto for the future of laboratory medicine professionals. Clin Chim Acta. 2019; 489: 49-52. Available at: https://doi.org/10.1016/j.cca.2018.11.021.Google Scholar Crossref PubMed Export Citation.