Nationwide Harmonization Effort for Semi-Quantitative Reporting of SARS-CoV-2 PCR Test Results in Belgium.

From early 2020, a high demand for SARS-CoV-2 tests was driven by several testing indications, including asymptomatic cases, resulting in the massive roll-out of PCR assays to combat the pandemic. Considering the dynamic of viral shedding during the course of infection, the demand to report cycle threshold (Ct) values rapidly emerged. As Ct values can be affected by a number of factors, we considered that harmonization of semi-quantitative PCR results across laboratories would avoid potential divergent interpretations, particularly in the absence of clinical or serological information. A proposal to harmonize reporting of test results was drafted by the National Reference Centre (NRC) UZ/KU Leuven, distinguishing four categories of positivity based on RNA copies/mL. Pre-quantified control material was shipped to 124 laboratories with instructions to setup a standard curve to define thresholds per assay. For each assay, the mean Ct value and corresponding standard deviation was calculated per target gene, for the three concentrations (107, 105 and 103 copies/mL) that determine the classification. The results of 17 assays are summarized. This harmonization effort allowed to ensure that all Belgian laboratories would report positive PCR results in the same semi-quantitative manner to clinicians and to the national database which feeds contact tracing interventions.

Diagnostic accuracy of the Triage D-dimer test for exclusion of venous thromboembolism in outpatients.

BACKGROUND: We evaluated the diagnostic performance of the Triage D-dimer test, a new fast quantitative point-of-care whole blood D-dimer assay and compared it with the Vidas D-dimer assay. MATERIALS AND METHODS: The study population comprised 319 outpatients for whom D-dimer testing was requested in order to rule out venous thromboembolism (VTE). Routine testing consisted of a plasma ELISA D-dimer analysis (Vidas). For all included patients, an additional EDTA whole blood D-dimer test (Triage) was performed. Patients were classified by reference imaging or by follow-up of the medical record. Accuracy indices, receiver operating characteristics and the kappa coefficient for agreement were calculated using the cutoff values recommended by the manufacturer. RESULTS: Prevalence of VTE was 14%. Sensitivity and specificity for VTE were 98% (95%CI: 88-100) and 34% (95%CI: 28-40) for Vidas and 91% (95%CI: 78-97) and 42% (95%CI: 36-48) for Triage, respectively. The differences in sensitivity and specificity between both D-dimer assays were statistically significant (McNemar, p<0.0001). ROC-curve analysis yielded an area under the curve of 0.83 (95%CI: 0.76-0.89) for the Vidas and 0.81 (95%CI: 0.74-0.88) for the Triage (p=0.396). The kappa coefficient for agreement between Vidas and Triage was 0.75 (95%CI: 0.68-0.79). CONCLUSIONS: The Triage and Vidas D-dimer tests show comparable diagnostic accuracy. Vidas showed a significant higher sensitivity. Our findings strongly suggest lowering the cutoff for the Triage D-dimer test from 400 to 350 ng/mL. In this way specificity lowers from 42 to 38%, but, more importantly, sensitivity increases from 91 to 95%.

Multicenter evaluation of a rapid electrochemiluminescent adrenocorticotropic hormone (ACTH) immunoassay.

BACKGROUND: Measuring plasma adrenocorticotropic hormone (ACTH) is a key step in the differential diagnosis of hypothalamic-pituitary-adrenal disorders. METHODS: The recently developed electrochemiluminescence Elecsys ACTH immunoassay (Roche Diagnostics, Mannheim, Germany) was evaluated at six clinical laboratories on the Modular E170 and/or the Elecsys 2010 (Roche Diagnostics) immunoanalysers. RESULTS: The within-run and between-run imprecision was

Third Belgian multicentre survey of antibiotic susceptibility of anaerobic bacteria.

OBJECTIVES: To collect recent data on the susceptibility of anaerobes and to compare them with results from previous studies. METHODS: Four hundred and forty-three anaerobic clinical isolates from various body sites were prospectively collected from October 2003 to February 2005 in nine Belgian hospitals. MICs were determined for nine anti-anaerobic and three recently developed antibiotics. RESULTS: Most gram-negative bacilli except Fusobacterium spp. were resistant to penicillin. Piperacillin/tazobactam, metronidazole, chloramphenicol, meropenem and amoxicillin/clavulanic acid were very active against all groups, but only 86% of Bacteroides fragilis group strains were susceptible to the latter. Cefoxitin, cefotetan and clindamycin were less active. In particular, only 62%, 52% and 48% of B. fragilis group strains were susceptible, respectively. Clindamycin shows a continuing decrease in activity, as 83% were still susceptible in 1987 and 66% in 1993-94. Anti-anaerobic activity of the new antibiotics is interesting, with MIC50 and MIC90 of 1 and >32 mg/L for moxifloxacin, 2 and 4 mg/L for linezolid and 0.5 and 8 mg/L for tigecycline. CONCLUSIONS: The susceptibility of anaerobic bacteria remains stable in Belgium, except for clindamycin, which shows a continuous decrease in activity. However, for each of the tested antibiotics, at least a few resistant organisms were detected. Consequently, for severe infections involving anaerobic bacteria, it could be advisable to perform microbiological testing instead of relying on known susceptibility profiles. Periodically monitoring background susceptibility remains necessary to guide empirical therapy.