RESUMEN
Timely and reliable laboratory diagnostics is a necessity for patient safety and good patient management. Success in external quality assessment (EQA) reflects on the everyday work in a clinical laboratory. This study evaluated the reliability of serological point-of-care (POC) testing for the Epstein-Barr virus (EBV) that causes infectious mononucleosis (IM). Data from the results of 95 external quality control (EQC) samples, altogether 18 885 results during an eight-year period (2010-2017) were collected from 273 Finnish testing sites. Diagnosing acute infectious mononucleosis (EBV IM) is based on clinical, haematological and serological findings. Heterophile antibody tests are used for this purpose because they can be carried out at POC and are cheap and robust to perform. In this study, the data showed that the testing sites used 3 test methods and 17 different test kits; of the kits, 4 were used during the whole study period. The most commonly used test methods were immunochromatographic assays (12 test kits, 17 959 EQC results). Latex agglutination (4 test kits, 504 results) and immunofiltration test methods (one kit, 422 results) were also used. The overall success rate was 99.3% (for positive samples 99.6%, for negative samples 99.1%). The success rates of the different test methods varied from 94.3% for the immunofiltration method to 99.6% for the latex agglutination method. The lowest success rates were found for negative samples: 82.0% (QuickVue, Quidel [immunochromatographic method]), 91.3% (RDT EBV IgM Assay, Bio-Rad [immunofiltration method]). The results of the negative samples that represented old EBV immunity were the most difficult to interpret with a success rate of 98.9% compared to success rates of clearly positive (99.6%) and negative (99.5%) samples (P < .001). Especially the immunofiltration method (RDT EBV IgM Assay) produced 13.7% false positive results for samples of old immunity. The data showed that 42 of the studied 95 EBV IM EQA rounds were reported as expected (true positive or true negative) by all testing sites.
RESUMEN
In Finland, all laboratories carrying out diagnostics of infectious diseases in humans are approved by the Regional State Administrative Agencies and are obligated to participate in External Quality Assurance rounds. Performance in these rounds is thought to reflect the quality of laboratory work. In the 6-year study period, 17 Finnish laboratories received 48 simulated faecal specimens for the culturing of diarrhoeal pathogens, yielding altogether 586 faecal culture External Quality Control specimens and 581 reports. The results were correct in 92% of all reports and in 67% of all specimens. False-negative Salmonella results were given for 2 of the 18 specimens, one with biochemically atypical Salmonella strain and the other with a low count of Salmonella cells. False-negative Shigella report was given for 6 of the 7 specimens in some participating laboratory. Detection of all common faecal pathogens is especially relevant to patient safety, public health, and epidemiological surveillance.