ABSTRACT
Background Since December 2019, Coronavirus 2019 (Covid-19) emerged in Wuhan city in China, and rapidly spread throughout China, Asia and worldwide. Recently, concerns emerged about specificity of PCR testing especially sensibility. We hypothesis first that clinical and/or biological and/or radiological characteristics of patients with first false negative COVID-19 RT-PCR test despite final diagnosis of COVID-19 are different from patients with first positive COVID-19 RT-PCR test.
Methods Case – control study in which patients with first negative COVID-19 RT-PCR test were matched to patients with first positive COVID-19 RT-PCR test on age, gender and ward/ICU location at time of RT-PCR test.
Results Between March 30, and June 22, 2020, 82 cases and 80 controls were included. Neither proportion of death at hospital discharge, nor duration of hospital length stay differed between patients “Cases” and “Controls” (respectively P=0.53 and P=0.79). In multivariable analysis, fatigue and/or malaise (aOR: 0.16 [0.03; 0.81]; P=0.0266), headache (aOR: 0.07 [0.01; 0.49]; P=0.0066) were associated with lower risk of false negative whereas platelets upper than 207 per 10.3.mm-3 (aOR: 3.81 [1.10; 13.16]; P=0.0344), and CRP>79.8 mg.L-1 (aOR: 4.00 [1.21; 13.19]; P=0.0226) were associated with higher risk of false negative.
Interpretation Patients suspected of COVID-19 with higher inflammatory biological findings expected higher risk of false negative COVID-19 RT-PCR test. Strategy of serial RT-PCR test must be rigorously evaluated before adoption by clinicians.
Competing Interest Statement
The authors have declared no competing interest.
Funding Statement
Not funded.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The study was approved by the appropriate ethics committees (For France: Comite d ethique de la Societe de Reanimation de Langue Francaise, #20-26; and for Belgium: Comite d ethique 045 Clinique Saint Pierre) which waived consent according to data collected.
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
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Data Availability
Data will be available upon request to corresponding author with protocol approved by IRB.