Choice criteria for different methodologies of Sars-CoV-2 diagnosis in clinical laboratories

In the end of 2019, we were startled by the SARS-CoV-2 pandemic, a virus that causes symptoms like other respiratory viruses. Therefore, the correct diagnosis through laboratory tests became necessary. However, there are many tests available on the market, and laboratories must choose the ones to employ. This study aimed to highlight the ways clinical analysis laboratories of the city of Porto Alegre, Brazil, choose each type of test to provide. This was a quantitative, retrospective study. The survey was carried out through an electronic form at the laboratories that were providing COVID-19 exams from 03/2020 to 02/2021. The form was applied in two phases. The first questions about the exams were carried out in the establishment itself, and the second in the outsourced exams. They were asked about the importance of reasons for choosing these tests from zero to five for some parameters. The analysis was simply descriptive. Of the 42 invited, 13 laboratories (31%) participated in the research;of these, 12 performed tests in their own laboratory, four only performed in their laboratory, and 8, in addition to performing in their laboratory, also outsourced, and 1 only outsourced. The most important choice reasons were performance characteristics and validation of the service itself, respectively. The nine laboratories that outsourced the tests presented the methodology used for diagnosis as the most important parameter. The parameters: partner support laboratory, registration within Anvisa, performance characteristics, and reliability in the partner laboratory were very relevant. The price was of average importance in both phases. © 2022, Conselho Federal de Medicina. All rights reserved.

Exposing and Overcoming Limitations of Clinical Laboratory Tests in COVID-19 by Adding Immunological Parameters; A Retrospective Cohort Analysis and Pilot Study.

Background: Two years since the onset of the COVID-19 pandemic no predictive algorithm has been generally adopted for clinical management and in most algorithms the contribution of laboratory variables is limited. Objectives: To measure the predictive performance of currently used clinical laboratory tests alone or combined with clinical variables and explore the predictive power of immunological tests adequate for clinical laboratories. Methods: Data from 2,600 COVID-19 patients of the first wave of the pandemic in the Barcelona area (exploratory cohort of 1,579, validation cohorts of 598 and 423 patients) including clinical parameters and laboratory tests were retrospectively collected. 28-day survival and maximal severity were the main outcomes considered in the multiparametric classical and machine learning statistical analysis. A pilot study was conducted in two subgroups (n=74 and n=41) measuring 17 cytokines and 27 lymphocyte phenotypes respectively. Findings: 1) Despite a strong association of clinical and laboratory variables with the outcomes in classical pairwise analysis, the contribution of laboratory tests to the combined prediction power was limited by redundancy. Laboratory variables reflected only two types of processes: inflammation and organ damage but none reflected the immune response, one major determinant of prognosis. 2) Eight of the thirty variables: age, comorbidity index, oxygen saturation to fraction of inspired oxygen ratio, neutrophil-lymphocyte ratio, C-reactive protein, aspartate aminotransferase/alanine aminotransferase ratio, fibrinogen, and glomerular filtration rate captured most of the combined statistical predictive power. 3) The interpretation of clinical and laboratory variables was moderately improved by grouping them in two categories i.e., inflammation related biomarkers and organ damage related biomarkers; Age and organ damage-related biomarker tests were the best predictors of survival, and inflammatory-related ones were the best predictors of severity. 4) The pilot study identified immunological tests (CXCL10, IL-6, IL-1RA and CCL2), that performed better than most currently used laboratory tests. Conclusions: Laboratory tests for clinical management of COVID 19 patients are valuable but limited predictors due to redundancy; this limitation could be overcome by adding immunological tests with independent predictive power. Understanding the limitations of tests in use would improve their interpretation and simplify clinical management but a systematic search for better immunological biomarkers is urgent and feasible.

Hospitalization budget impact during the COVID-19 pandemic in Spain.

OBJECTIVES: The aim was to determine the direct impact of the COVID-19 pandemic on Spain's health budget. METHODS: Budget impact analyses based on retrospective data from patients with suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) admitted to a Spanish hospital between February 26 and May 21, 2020. Direct medical costs from the perspective of the hospital were calculated. We analyzed diagnostic tests, drugs, medical and nursing care, and isolation ward and ICU stays for three cohorts: patients seen in the emergency room only, hospitalized patients who tested positive for SARS-CoV-2, and patients who tested negative. RESULTS: The impact on the hospital's budget for the 3 months was calculated at €15,633,180, 97.4% of which was related to health care and hospitalization. ICU stays accounted for 5.3% of the total costs. The mean cost per patient was €10,744. The main costs were staffing costs (10,131 to 11,357 €/patient for physicians and 10,274 to 11,215 €/patient for nurses). Scenario analysis showed that the range of hospital expenditure was between €14,693,256 and €16,524,924. The median impact of the pandemic on the Spanish health budget in the sensitivity analysis using bootstrapped individual data was €9357 million (interquartile range [IQR], 9071 to 9689) for the conservative scenario (113,588 hospital admissions and 11,664 ICU admissions) and €10,385 million (IQR, 110,030 to 10,758) for the worst-case scenario (including suspected cases). CONCLUSION: The impact of COVID-19 on the Spanish public health budget (12.3% of total public health expenditure) is greater than multiple sclerosis, cancer and diabetes cost.