Background: Mild to moderate bleeding disorders are a diagnostic challenge. Many patients remain undiagnosed despite thorough and repeated laboratory testing.Thrombin generation (TG) is an overall assay measuring the functionality of the hemostatic system and may be a useful tool in diagnosing patients with bleeding tendency.
Objectives:We examined the added value of TG in patients with mild bleeding tendency with and without diagnosis after classical laboratory testing. Further, we investigated the role of different expressions of results, between-method variation, and reference ranges.Methods: TG of patients and controls was measured in parallel by two TG platforms (ST Genesia and calibrated automated thrombogram [CAT]). All TG parameters in patient and control groups were compared by statistical analysis (Mann-Whitney U tests) including visual representation with box-and-whisker plots. Results were expressed as normalized ratios (ST Genesia and CAT) or corrected values (ST Genesia). Reference intervals were calculated to which patient results were compared. We studied lot-tolot reagent variability for both platforms.Results: In 62.7% (ST Genesia) to 69.5% (CAT) of patients undiagnosed with a traditional laboratory work-up, abnormal TG parameters (lag time and endogenous thrombin potential expressed as normalized ratio and/or corrected value) were detected.In the group of previously diagnosed patients, abnormal parameters were found in 58.1% of patients for both TG assays. No relevant lot-to-lot reagent variability was observed.Conclusions: Adding TG helps with diagnosing patients with mild bleeding disorder.TG seems a promising tool in diagnosis of bleeding tendency, but further evaluation is necessary before application in diagnostic laboratory testing.
BackgroundReal-time polymerase chain reaction (RT-PCR) testing on a nasopharyngeal swab is the current standard for SARS-CoV-2 virus detection. Since collection of this sample type is experienced uncomfortable by patients, saliva- and oropharyngeal swab collections should be considered as alternative specimens.ObjectivesEvaluation of the relative performance of oropharyngeal swab, nasopharyngeal swab and saliva for the RT-PCR based SARS-CoV-2 Delta (B.1.617.2) and Omicron (B.1.1.529) variant detection.Study designNasopharyngeal swab, oropharyngeal swab and saliva were collected from 246 adult patients who presented for SARS-CoV-2 testing at the screening centre in Ypres (Belgium). RT-PCR SARS-CoV-2 detection was performed on all three sample types separately. Variant type was determined for each positive patient using whole genome sequencing or Allplex SARS-CoV-2 variants I and II Assay.Results and conclusionsSaliva is superior compared to nasopharyngeal swab for the detection of the Omicron variant. For the detection of the Delta variant, nasopharyngeal swab and saliva can be considered equivalent specimens. Oropharyngeal swab is the least sensitive sample type and shows little added value when collected in addition to a single nasopharyngeal swab.HighlightsSaliva is the preferred sample type for Omicron variant (B.1.1.529) detectionNasopharyngeal swab and saliva are equivalent for Delta variant (B.1.617.2) detectionOropharyngeal swab is the least preferred sample type for SARS-CoV-2 detection
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