Sojeong Yun, B.S., Ji Hyeong Ryu, M.S., Joo Hee Jang, B.S., Hyunjoo Bae, M.S., Seung-Hyo Yoo, M.T., Ae-Ran Choi, M.T., Sung Jin Jo, M.D., Jihyang Lim, M.D., Jehoon Lee, M.D., Hyejin Ryu, M.D., Sung-Yeon Cho, M.D., Dong-Gun Lee, M.D., Jongmin Lee, M.D., Seok Chan Kim, M.D., Yeon-Joon Park, M.D., Hyeyoung Lee, M.D., and Eun-Jee Oh, M.D.. Ann Lab Med 2021;41:577-87. https://doi.org/10.3343/alm.2021.41.6.577

Infectious diarrhea is a global pediatric health concern; therefore, rapid and accurate detection of enteropathogens is vital. We evaluated the BioFire^® FilmArray^® Gastrointestinal (GI) Panel with that of comparator laboratory tests. Stool samples of pediatric patients with diarrhea were prospectively collected and tested. As a comparator method for bacteria, culture, conventional PCR for diarrheagenic E. coli, and Allplex GI-Bacteria(I) Assay were tested. For discrepancy analysis, BD MAX Enteric Bacterial Panel was used. As a comparator method for virus, BD MAX Enteric Virus Panel and immunochromatography was used and Allplex GI-Virus Assay was used for discrepancy analysis. The “true positive” was defined as culture-positive and/or positive results from more than two molecular tests. Of the 184 stool samples tested, 93 (50.5%) were true positive for 128 pathogens, and 31 (16.9%) were positive for multiple pathogens. The BioFire GI Panel detected 123 pathogens in 90 of samples. The BioFire GI Panel demonstrated a sensitivity of 100% for 12 targets and a specificity of >95% for 16 targets. The overall positive rate and multiple pathogen rate among patients in the group without underlying diseases were significantly higher than those in the group with hematologic disease (57.0% vs. 28.6% (p = 0.001) and 20.4% vs. 4.8% (p = 0.02), respectively). The BioFire GI Panel provides comprehensive results within 2 h and may be useful for the rapid identification of enteropathogens.

Background: Severe sepsis and septic shock are the leading cause of in-hospital death. As sepsis progresses, expression and activity of endogenous mediators of inflammation change. Early detection of biomarkers can play a role in sepsis screening and in improvement of patient outcomes. Recent studies suggest that increase in monocyte volume may be helpful in early detection of sepsis. Therefore, we evaluated the utility of monocyte distribution width (MDW) for the early assessment of sepsis compared with the blood culture and other inflammatory biomarkers. Methods: Medical records of 1,404 patients (aged ≥19 years) who were admitted to the emergency department owing to clinically suspected infectious disease and requested blood cultures from Oct 2019 to Jan 2021 were reviewed. The patients were grouped based on Sepsis-3 criteria. They had undergone other laboratory tests to evaluate their clinical status. MDW was analyzed using DxH900 hematology analyzer (Beckman Coulter, Brea, California, USA). To determine the diagnostic performance of MDW, C-reactive protein (CRP), and procalcitonin (PCT) for sepsis, the area under the curve (AUC) of receiver operating characteristics curves and their sensitivity and specificity were measured. Results: Among 1,404 patients, 520 patients were designated the sepsis group based on Sepsis-3 criteria. In the sepsis group, MDW value was 24.1 (median, IQR 21.6–28.1); AUC values for MDW, CRP, and PCT were 0.67 (95% CI, 0.64–0.69), 0.66 (95% CI, 0.63–0.68), and 0.75 (95% CI, 0.72–0.77), respectively. For diagnosis of the sepsis, the cut-off value of MDW was 21.7 (sensitivity 74% and specificity 54%). Measured values of MDW were higher for the blood culture positive group than that of the blood culture contamination group (P<0.001, 95% CI, -5.9 to -3.0) or blood culture negative group (P<0.001, 95% CI = -5.8 to -4.2). Conclusions: MDW is a new hematological parameter that is simultaneously calculated during complete blood cell counting by Beckman Coulter hematology analyzer. MDW is expected to serve as a useful indicator for early screening of sepsis in conjunction with CRP and PCT. MDW is especially useful for sepsis assessment in patients with a suspected infection. MDW can also assist in discriminating false positive blood cultures.

We evaluated the performance of the BioFire^® FilmArray^® Pneumonia panel (PN-panel) in detecting bacterial pathogens by comparing it to cultures and to the usefulness of the leukocyte esterase (LE) urine strip test. Between January and June 2022, a total of 67 sputum specimens were obtained from community-acquired pneumonia patients. The PN-panel and LE test were performed simultaneously with conventional cultures. The pathogen detection rates of the PN-panel and culture were 40/67 (59.7%) and 25/67 (37.3%), respectively. The concordance rate between the PN-panel and culture was high (76.9%) when the bacterial burden was high (10⁷ copies/mL), but it was low (8.6%) when it was 10⁴⁻⁶ copies/mL, irrespective of the sputum quality. According to the LE positivity, the overall culture positive rate and PN-panel positive rate were significantly higher among the LE-positive specimens (23/45, 31/45) than among the LE-negative specimens (2/21, 8/21). Moreover, the difference in concordance rate between the PN-panel test and culture was significant according to the LE positivity, but not the Gram stain grading. In conclusion, the PN-panel showed high concordance when the bacterial burden was high (10⁷ copies/mL) and ancillary use of LE test will be helpful in interpreting the PN-panel results, especially when the copy number of bacterial pathogens is low.

Rapid antigen (Ag) tests for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) provide quick results, do not require specialized technical skills or infrastructure, and can be used as a point-of-care method to prevent the spread of coronavirus disease (COVID-19). The performance of a magnetic force-assisted electrochemical immunoassay-based test, namely the MARK-B COVID-19 Ag test (BBB, Sungnam, Republic of Korea), was evaluated using 170 nasopharyngeal swab specimens and compared to that of RT-PCR and commercial rapid Ag test (STANDARD Q COVID-19 Ag Test, SD Biosensor, Suwon-si, Republic of Korea). The overall sensitivity and specificity of the MARK-B test were 90.0% (95% CI 79.4%–96.2%) and 99.0% (95% CI 95.0%–99.9%), respectively, with a kappa coefficient of 0.908. The correlations between the electrical current values of MARK-B and the Ct values of RT-PCR were −0.898 (E gene, 95% CI −0.938 to −0.834) and −0.914 (RdRp gene, 95% CI −0.948 to −0.860), respectively. The limit of detection of the MARK-B was measured using the viral culture reference samples and found to be 1 x 10² pfu/mL. The magnetic force-assisted electrochemical immunoassay-based Ag test can be used to rapidly detect SARS-CoV-2 infections, and the corresponding fully automated portable device can provide easy readability and semi-quantitative results.

In Young Yoo, M.D., Ph.D., Sungjin Jo, M.D., Ph.D., Joo An Kwon, M.T., Jay Ho Han, M.D., Ph.D., Hae Kyung Lee, M.D., Ph.D., and Yeon-Joon Park, M.D., Ph.D.. Ann Lab Med -0001;0:. https://doi.org/10.3343/alm.2025.0047