Evaluation of molecular methods for plasma detection of EGFR mutations in non-small cell lung cancer.

AIM: Epidermal growth factor receptor (EGFR) mutations are detected in non-small cell lung cancer (NSCLC) and associated with responses to therapy with tyrosine kinase inhibitors (TKIs). We compared the analytical performances of two real-time PCRs and droplet digital PCR (ddPCR) to detect EGFR mutations using plasma. METHODS: Plasma EGFR tests were performed using 86 plasma samples from 75 prospectively enrolled NSCLC patients with early and advanced stages. Analytical performances of plasma-using two real-time PCR, Cobas EGFR mutation v2 and PANAMutyper, EGFR kit, and ddPCR were evaluated based on the tissue EGFR test results. The frequencies of EGFR mutations and acquired T790M mutation after TKI therapy were also assessed. RESULTS: The incidence of all EGFR mutations was 52.3% (23/44) in tissue and was up to 43.2% (19/44) in plasma. The Cobas detection rates of three EGFR mutations (exon 19 deletions, L858R, and T790M) in plasma were similar to those in tissue. The Cobas showed a higher detection rate (76.7%) than that by the PANAMutyper (60.5%). Sensitivity for T790M mutation was lower than the sensitivity for the exon 19 deletions or L858R in both tests. Mutant allele frequency measured by ddPCR was significantly correlated with the semi-quantitative values of the Cobas. CONCLUSIONS: Plasma EGFR tests showed similar detection rates for common EGFR mutations compared to the tissue EGFR tests. Cobas showed higher sensitivity in detection of EGFR mutations in body fluids than the PANAMutyper. Real-time PCR using plasma or body fluids could be a suitable first test for the detection of EGFR mutations.

Evaluation of Cobas 8000 Analyzer Series Module e801 Analytical Performance.

BACKGROUND: Immunoassays are important tests that provide essential information for patient care. The e801, a module of the recently released Cobas 8000 series (Roche Diagnostics, Mannheim, Germany), is an automated immunoassay system based on streptavidin-biotin interactions. In this study, we evaluated the analytical performance of the e801. METHODS: We evaluated the precision, linearity, assay comparison, and reference range validation of 16 analytes (AFP, CA19-9, CA125, CEA, CYFRA, ferritin, NSE, PSA, Vitamin D, E2, fT4, TSH, FSH, insulin, NT-proBNP, and T) according to the guidelines of the Clinical Laboratory Standards Institute. RESULTS: In precision evaluations, the coefficients of variation were less than each allowable total error for all analytes. Linearity was observed for all analytes over the entire tested analytical range (r2≥0.99). Performance comparisons revealed that the two systems are comparable, with correlation coefficients (r)>0.975 for all analytes. The reference range validation was also within the allowable criteria. CONCLUSIONS: In this study, the Cobas 8000 e801 analyzer demonstrated acceptable performance with respect to precision, linearity, reference range validation, and correlation. Therefore, the e801 analyzer is expected to be useful for routine immunoassays in clinical laboratories, although education and awareness about biotin interference is necessary for successful implementation in clinical practice.

Evaluation of the Elecsys Syphilis electrochemiluminescence immunoassay as a first-line screening test in the reverse algorithms for syphilis serodiagnosis.

OBJECTIVES: With the development of the automated treponemal test, new syphilis serodiagnosis algorithms, reverse algorithm, and European Centre for Disease Prevention and Control (ECDC) algorithm have been recommended recently. We investigated the efficacy of an electrochemiluminescence immunoassay (ECLIA) as an initial screening test in the reverse and ECDC algorithms. METHODS: Samples from 4,771 subjects were included in this study. We performed rapid plasma reagin (RPR), ECLIA, and Treponema pallidum particle agglutination (TPPA) according to these three algorithms. The fluorescent treponemal antibody absorbed (FTA-ABS) test was additionally applied for discordant cases between the RPR and ECLIA results. The FTA-ABS results and the consensus of three algorithms were considered a gold standard. RESULTS: A total of 208 subjects were diagnosed with syphilis. The traditional algorithm had a sensitivity of 25.96%, specificity of 100%, and accuracy of 96.77%. Both the reverse and ECDC algorithms showed the same diagnostic performance, sensitivity of 95.19%, specificity of 99.96%, and accuracy of 99.75%. The agreements between the traditional algorithm and the other algorithms were 96.9% with a kappa value of 0.415. CONCLUSIONS: The diagnostic accuracy of the reverse and ECDC algorithms using the ECLIA as a first-line screening test was superior to that of the traditional algorithm.

Biliary Taeniasis with Cholecystitis: An Unusual Case of Taenia solium Infection with a Literature Review.

Taeniasis is a cosmopolitan helminthic disease caused by Taenia species, which included Taenia solium, Taenia saginata, and Taenia asiatica. These parasites typically infect the small intestine, but cases of aberrant migration have been reported. We treated a 70-year-old man who presented with vomiting and colicky abdominal pain. On physical examination, Murphy's sign was positive, and laboratory findings indicated severe inflammation. Computed tomography and magnetic resonance cholangiopancreatography revealed typical features of cholecystitis. An 82-cm-long, slender and degenerated, parasite-like organism was aspirated through a percutaneous transhepatic gallbladder drainage tube. After extensive washing of the organism, we detected yellowish-brown colored, spherical 37.9 × 33.8-µm-sized taenid eggs with thick transverse striations. Hematoxylin-eosin-stained worm sections also contained Taeniidae eggs. Polymerase chain reaction amplification of DNA extracted from the worm with species-specific cytochrome c1 (cox1) primer sets detected a T. solium-specific fragment. Because of sustained high fever combined with inflammatory signs, the patient underwent laparoscopic cholecystectomy and inflamed gallbladder removal. A histopathologic specimen demonstrated chronic reactive cholecystitis. The patient's fever and leukocytosis rapidly resolved after surgery. We experienced an uncommon case of biliary taeniasis representing cholecystitis caused by adult worm of T. solium.

Urine Cotinine level with smoking history predicts a risk of coronary artery calcification.

We investigated whether urine cotinine level, alone or combined with smoking status and cumulative smoking amount, could predict coronary calcium (CAC) score increase over time. The study population included 10,980 subjects. We analysed an association between CAC score increase over time and single or combined smoking-related factors. Urine cotinine level of ≥100 ng/mL, current or ex-smokers, and cumulative smoking amount of ≥1 pack-years (PY) showed significantly higher odds ratios (ORs) for CAC score increase over time. A combination of current smokers with >10 PY and urine cotinine level of ≥100 ng/mL showed the highest OR. Irrespective of smoking status and cumulative smoking amount, all combinations with urine cotinine of ≥100 ng/mL showed higher ORs than other combinations with urine cotinine level of <100 ng/mL. Urine cotinine levels can be useful to predict coronary artery calcification and encourage smokers to quit smoking.

Evaluation of the URiSCAN 2 ACR Strip to estimate the urine albumin/creatinine ratios.

BACKGROUND: The urine albumin/creatinine ratio (ACR) test is used to screen patients with chronic diseases, such as diabetes, hypertension and cardiovascular diseases that put them at an increased risk of developing kidney disease. Here, we evaluated the performance of the URiSCAN 2 ACR Strip (URiSCAN; YD diagnostics, Yongin, Korea), a semiquantitative point-of-care testing (POCT) assay, and we compared to an existing POCT assay and a quantitative assay. MATERIALS AND METHODS: A total of 1,020 random urine specimens were analyzed using the semiquantitative URiSCAN 2 ACR Strip and semiquantitative CLINITEK Microalbumin 2 Strip (CLINITEK; Siemens, New York, USA). We evaluated the precision of the URiSCAN 2 ACR Strip and compared the results of the ACR obtained from URiSCAN to those of CLINITEK with the quantitative results of a quantitative assay as a reference. RESULTS: The precision evaluation of the URiSCAN revealed a range between the cutoff (C50 )-20% and C50 +20% bounds, the C5 -C95 interval, with 85.8% confidence. URiSCAN and CLINITEK showed sensitivity and specificity of 87.7% and 72.2%, and 90.2% and 83.0%, respectively. The concordance rates of URiSCAN with CLINITEK and the quantitative assay were 75.6% and 79.1%, respectively. The concordance rate in the abnormal range (≥30 mg/g) between URiSCAN and the quantitative assay were higher than that between CLINITEK and the quantitative assay (78.8% vs 75.4%). CONCLUSIONS: URiSCAN showed good precision and comparable sensitivity with lower specificity than those of CLINITEK.