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. 2023 Feb 28;13(2):e069455.
doi: 10.1136/bmjopen-2022-069455.

Validating a clinical laboratory parameter-based deisolation algorithm for patients with COVID-19 in the intensive care unit using viability PCR: the CoLaIC multicentre cohort study protocol

Tom Schoenmakers  1   2 , Bas C T van Bussel  3   4   5 , Stefan H M Gorissen  6 , Inge H M van Loo  4   7 , Frank van Rosmalen  3   5 , Wilhelmine P H G Verboeket-van de Venne  8 , Petra F G Wolffs  4   7 , Walter N K A van Mook  3   9 , Mathie P G Leers  8   2   3 ; CoLaIC-consortium; CoLaICconsortium
Collaborators, Affiliations

Validating a clinical laboratory parameter-based deisolation algorithm for patients with COVID-19 in the intensive care unit using viability PCR: the CoLaIC multicentre cohort study protocol

Tom Schoenmakers et al. BMJ Open. .

Abstract

Introduction: To investigate whether biochemical and haematological changes due to the patient's host response (CoLab algorithm) in combination with a SARS-CoV-2 viability PCR (v-PCR) can be used to determine when a patient with COVID-19 is no longer infectious.We hypothesise that the CoLab algorithm in combination with v-PCR can be used to determine whether or not a patient with COVID-19 is infectious to facilitate the safe release of patients with COVID-19 from isolation.

Methods and analysis: This study consists of three parts using three different cohorts of patients. All three cohorts contain clinical, vital and laboratory parameters, as well as logistic data related to isolated patients with COVID-19, with a focus on intensive care unit (ICU) stay. The first cohort will be used to develop an algorithm for the course of the biochemical and haematological changes of the host response of the COVID-19 patient. Simultaneously, a second prospective cohort will be used to investigate the algorithm derived in the first cohort, with daily measured laboratory parameters, next to conventional SARS-CoV-2 reverse transcriptase PCRs, as well as v-PCR, to confirm the presence of intact SARS-CoV-2 particles in the patient. Finally, a third multicentre cohort, consisting of retrospectively collected data from patients with COVID-19 admitted to the ICU, will be used to validate the algorithm.

Ethics and dissemination: This study was approved by the Medical Ethics Committee from Maastricht University Medical Centre+ (cohort I: 2020-1565/300523) and Zuyderland MC (cohorts II and III: METCZ20200057). All patients will be required to provide informed consent. Results from this study will be disseminated via peer-reviewed journals and congress/consortium presentations.

Keywords: COVID-19; Clinical chemistry; Diagnostic microbiology; Epidemiology; HAEMATOLOGY; INTENSIVE & CRITICAL CARE.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Overview of the study. ICU, intensive care unit; RT-PCR, reverse transcriptase PCR; SOFA, Sequential Organ Failure Assessment.
Figure 2
Figure 2
Schematic representation of the principles of the conventional SARS-CoV-2 reverse transcriptase PCR (RT-PCR) (route 1) in comparison to the viability PCR (route 2). Route 1: all RNA is isolated from the sample and amplified using RT-PCR. Route 2: propidium monoazide (PMA) irreversibly binds to free RNA and RNA from non-intact virus particles. Only RNA from intact virus particles is isolated and amplified by RT-PCR.
See this image and copyright information in PMC

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