Baseline glycated albumin level and risk of type 2 diabetes mellitus in Healthy individuals: a retrospective longitudinal observation in Korea.

Glycated albumin (GA) reflects glycemic status for the past three weeks. GA level demonstrates a strong correlation with HbA1c level and is used as an adjunctive biomarker for diagnosis and monitoring of type 2 diabetes mellitus (T2DM). In this study, we validated the predictive performance of baseline GA for development of T2DM in healthy individuals in Korea. From August 2013 to September 2014, the medical records of 3,771 healthy Koreans were retrospectively reviewed. Each participant was categorized into tertiles based on initial GA level. During the follow-up period through May 2020, study participants were evaluated for T2DM using HbA1c, fasting glucose level, and a self-reported diagnosis history. Baseline GA level by tertile (T1 to T3) was 10.4 ± 0.8% (mean ± SD), 12.1 ± 0.3%, and 13.7 ± 0.9%, respectively. The median follow-up was 5.97 years, during which 4.9% (186 of 3,771) of the participants developed T2DM. After adjusting for confounding factors, the hazard ratio for the development of T2DM in the highest GA level group (T3) compared to the reference group (T1) was 2.46 (95% CI, 1.7 to 3.58, p < 0.001 for trend) with a Harrell's C index of 0.80 (95% CI, 0.76 to 0.83). Also, within highest group of baseline HbA1c and FG levels, higher GA levels were associated with an increased HRs for T2DM. In conclusion, Our study confirms that the risk of T2DM increases with baseline GA level. Additional follow-up of the cohort is warranted to investigate the correlations between GA and other clinical indicators including diabetic complications.

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.

Comparison of AdvanSure HPV GenoBlot and Hybrid Capture 2 assays for detection of HPV infection.

BACKGROUND: We sought to compare the performance of the AdvanSure assay to the Hybrid Capture (HC) 2 for the detection of high-risk human papillomavirus (HR HPV). METHODS: A total of 855 cervical swab specimens were obtained. We submitted all specimens for HR HPV detection with HC2 and the AdvanSure assay. We subsequently analyzed discordant results and specimens that were positive on both assays using restriction fragment mass polymorphism (RFMP) genotyping analysis. RESULTS: HC2 yielded positive results in 12.0% of specimens, while the AdvanSure assay detected one of 13 HR HPV types in 11.5% of specimens. The overall agreement rate between the assays was 98.5% with a kappa coefficient of 0.928. Discordant results between these two assays were observed in 12 cases, seven were positive only on HC2 and five were positive only on AdvanSure. RFMP analysis of the 12 discordant cases revealed three false-positive results using HC2, and one false-positive and five false-negative results using AdvanSure. CONCLUSIONS: Considering the high agreement rate with HC2 and the ability to differentiate 35 HPV genotypes including HPV 16/18, the AdvanSure assay could be used as a laboratory testing method for HPV infection screening.

Comparison of GeneFinder human papillomavirus (HPV) Liquid Beads Microarray PCR Kit and Hybrid Capture 2 Assay for Detection of HPV Infection.

BACKGROUND: Along with advances in methodological technologies, various assays for detecting high-risk human papillomavirus (HR HPV) have been introduced. The GeneFinder HPV liquid beads microarray PCR kit is one of the recently developed. Our aim was to compare the performance of GeneFinder to Hybrid Capture 2 for detection of HR HPV. METHODS: A total of 900 cervical swab specimens were obtained. All specimens were submitted for HR HPV detection with Hybrid Capture 2 (HC2) and GeneFinder and then additionally analyzed the discordant or both positive results using restriction fragment mass polymorphism (RFMP) genotyping analysis. RESULTS: Hybrid Capture 2 detected 12.8% cases and GeneFinder detected 15.8% cases with 13 HR HPV types. Also, GeneFinder detected 27.4% cases for 32 detectable HPV types. The overall agreement rate was 93.2% with 0.724 kappa coefficient. Discordant results between these two assays were observed in 56 cases. HC2 showed sensitivity of 83.5% and specificity of 95.9%, while GeneFinder showed sensitivity of 85.4% and specificity of 91.9%. For HPV 16 or HPV 18 detection, GeneFinder showed 95.0% or 66.7% of sensitivity and 99.2% or 100%, respectively. Overall coinfection rate was 15.4% (38/247) in GeneFinder analysis. CONCLUSIONS: Considering the high agreement rate with HC2, high sensitivity and the ability to differentiate 32 HPV genotypes including HPV 16/18, GeneFinder could be used as a laboratory testing method for the screening of HPV infections. The use of GeneFinder may also contribute to future research associated with the significance of various HPV types and multiple coinfections.

Pd/C-Catalyzed Carbonylative Esterification of Aryl Halides with Alcohols by Using Oxiranes as CO Sources.

A carbonylative esterification reaction between aryl bromides and alcohols, promoted by Pd/C and NaF in the presence of oxiranes, has been developed. In this process, oxiranes serve as sources of carbon monoxide by their conversion to aldehydes through a palladium-promoted Meinwald rearrangement pathway. Intramolecular versions of this process serve as methods for the synthesis of lactones and phthalimides.

Diagnostic performance and establishment of reference limits of HE4 in Korean healthy women.

OBJECTIVE: We aimed to establish distribution and reference limits of HE4 and risk of ovarian malignancy algorithm (ROMA) in healthy Korean women and investigated the factors influencing HE4 levels. We also investigated the diagnostic performances of HE4 and ROMA score, compared with CA125. METHODS: We collected specimens from 1809 healthy Korean women, 140 specimens from patients with ovarian cancers (OCs) and 123 specimens from patients with benign ovarian tumor. Serum HE4 and CA125 concentrations were measured using an electrochemiluminescence immunoassay. The receiver operator characteristic (ROC) curve analysis was done for ROMA, HE4, CA125 and combining of HE4 and CA125. RESULTS: HE4 level was influenced by age, not by menopausal status. The 97.5th percentile upper reference limit of HE4 of subjects <50years and ≥50year-old was 63.87pmol/L and 88.28pmol/L, respectively. The 97.5th percentile upper reference limits of ROMA score were 13.66 in premenopausal and 19.30 in postmenopausal women. The serum HE4 level was even lower in the patients with benign tumor compared to those in healthy controls. HE4 had significantly higher concentrations in OCs than benign ovarian tumor (P<0.001). ROMA and HE4 combined with CA125 or not performed better diagnostically than CA125 alone for distinguishing OCs, with AUCs of 0.844 for ROMA, 0.827 for combining of HE4 and CA125, 0.825 for HE4, and 0.795 for CA125. CONCLUSIONS: The reference limit of HE4 was different from those reported by other studies, suggesting racial or regional difference. HE4 and ROMA were better than CA125 for differentiation normal and benign ovarian tumor from OCs. (Word count: 253).

Analysis of 25-Hydroxyvitamin D Status According to Age, Gender, and Seasonal Variation.

BACKGROUND: The effects of age, gender, and seasonal variation on human levels of 25-hydroxyvitamin D (25(OH)D) are not well understood. In this study, we aimed to investigate 25(OH)D status according to these factors in a Korean population. METHODS: A total of 303,943 serum 25(OH)D levels were measured using an electrochemiluminescence immunoassay between October 2011 and May 2014. Potential participants were ineligible for the study if they had significant renal, hepatic, or thyroid dysfunction, as well as any major ongoing disease that could influence serum 25(OH)D levels. RESULTS: A total of 95,137 subjects (49,662 men and 45,475 women) were included in this study. The mean 25(OH)D levels were higher in men (42.4 nmol/l) than in women (32.9 nmol/l, P < 0.001). Among the men and women, 73.0% and 88.9%, respectively, had 25(OH)D levels <50 nmol/l, whereas only 3.8% of men and 1.4% of women had levels >75 nmol/l. The highest mean 25(OH)D value was noted in individuals aged ≥70 for both genders. The proportion of those with 25(OH)D levels <50 nmol/l appeared to be higher among younger subjects (P < 0.001). Lastly, there were significant differences between 25(OH)D levels in individuals during summer to fall and winter to spring in both genders, indicating seasonal periodicity (P < 0.001). CONCLUSIONS: Serum 25(OH)D status varied according to gender, age, and season. Therefore, analyses of vitamin D status require individualized gender, age, and seasonally adjusted thresholds. Clinicians should consider these factors when determining optimal serum 25(OH)D levels in clinical practice.

Performance Evaluation of Three URiSCAN Devices for Routine Urinalysis.

BACKGROUND: This study compares the diagnostic performance (in routine urinalysis) of three URiSCAN devices and three Roche analyzers to manual microscopy and quantitative assays. METHODS: We analyzed eight dipstick tests using three URiSCAN devices. The results were compared to those of the tests performed using three Roche analyzers. The results of leukocyte and erythrocyte screens were compared to those obtained using manual microscopy. Protein, glucose, pH, and specific gravity (SG) assays performed on the URiSCAN devices were compared with the results of corresponding quantitative assays. RESULTS: The rates of agreement within one grade difference were found to be more than 94.3%. When compared with manual microscopy, the Optima provided better diagnostic performance for the detection of leukocytes compared with the Urisys 1100. Compared to the Urisys 2400, the Super plus provided better diagnostic performance with regard to both leukocytes and erythrocytes. There was good correlation between the three URiSCAN devices and each quantitative assay, except for SG detection. CONCLUSION: There were well correlated results between those of the three URiSCAN devices and those obtained using the corresponding Roche analyzers, quantitative assays, and manual microscopy. URiSCAN series devices are therefore suitable for routine urinalysis in clinical laboratories.

Comparison of clinical performances among Roche Cobas HPV, RFMP HPV PapilloTyper and Hybrid Capture 2 assays for detection of high-risk types of human papillomavirus.

The cervical cancer screening guidelines suggest that early detection of HPV16 and HPV18 is helpful for identifying women with cervical intraepithelial neoplasia (CIN) grade two or higher. We comparatively evaluated three HPV DNA assays, Roche Cobas HPV, RFMP HPV PapilloTyper, and Hybrid Capture 2 (HC2). A total of 861 cervical swab samples from women over 30 years of age were classified into two groups, that is, high grade squamous intraepithelial lesion (HSIL) and non-HSIL, according to cervical cytology results and analyzed by three assays. The results of direct sequencing or Linear array HPV genotyping test were considered true when the three assays presented discrepancies. The concordance rates between Roche Cobas HPV versus RFMP HPV PapilloTyper, RFMP HPV PapilloTyper versus HC2, and Roche Cobas versus HC2 were 94.5%, 94.3%, and 95.9%, respectively. For detection of HPV16 and HPV18, Roche Cobas HPV showed the concordance rates of 98.3% (κ = 0.73) and 99.4% (κ = 0.40) with the confirmation tests, respectively; and RFMP HPV PapilloTyper showed the concordance rates of 99.5% (κ = 0.92) and 100.0% (κ = 1.00), respectively. In conclusion, Roche Cobas HPV, RFMP HPV PapilloTyper, and HC2 showed high agreement rates. Roche Cobas HPV and RFMP HPV PapilloTyper are particularly useful, since both provide HPV specific genotypes, HPV16 and HPV18.

Comparison of chronic kidney disease prevalence examined by the chronic kidney disease epidemiology collaboration equation with that by the modification of diet in renal disease equation in Korean adult population.

BACKGROUND: The new estimated glomerular filtration (eGFR) equation, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, was recently introduced. We compared the prevalence of CKD examined by the CKD-EPI equation with that by the Modification of Diet in Renal Disease (MDRD) equation. METHODS: We analyzed the data from a total of 14,605 Korean adults (age ≥20 years), who were enrolled in the Korean National Health and Nutrition Examination Survey in 2007, 2009, and 2010. CKD stages 1 and 2 were defined as eGFR ≥60 mL/min/1.73 m(2) with proteinuria measured by dipstick. CKD stages 3-5 were defined as eGFR <60 mL/min/1.73 m(2) . RESULTS: The eGFRs calculated by the CKD-EPI equation were higher than those calculated by the MDRD equation (P < 0.001), especially in women and young people. The prevalence of CKD stages 3-5 calculated by the MDRD equation was 6.8%, 3.0%, and 3.0% in 2007, 2009, and 2010, respectively. The prevalence of CKD stages 3-5 calculated by CKD-EPI equation was 7.7%, 2.7%, and 2.6% in 2007, 2009, and 2010, respectively. When defining the CKD using the CKD-EPI equation, 55 (32.7%) of 350 cases were reclassified into more advanced stages and 295 cases (67.3%) were reclassified into less-advanced stages. CONCLUSION: The CKD-EPI equation caused an overall low prevalence of CKD compared to the MDRD. Therefore, CKD-EPI equation might be helpful to prevent an overestimation of CKD.

Performance evaluation of the Allplex HPV HR Detection assay in comparison with the Cobas HPV test for high-risk HPV genotyping.

Molecular testing for high-risk human papillomavirus (hrHPV) genotypes is important in screening for cervical cancer. In this study, we evaluated the performance of a newly developed Allplex HPV HR Detection assay in comparison with the Cobas HPV Test. A total of 1,275 cervical specimens obtained from a healthcare center between August 2021 and May 2022 were analyzed. The overall agreement for hrHPV detection was 98.4%, with higher agreement observed for HPV-16 (99.7%) and HPV-18 (99.8%) compared to other hrHPV genotypes (97.2%). Sequencing revealed that the majority of discrepancies was genotyped accurately by the Allplex HPV HR Detection assay with the exception of one false positive for HPV-16 and two false positives for other hrHPV genotypes. The Allplex HPV HR Detection assay showed almost perfect agreement with the Cobas HPV test, emphasizing its utility in hrHPV screening and monitoring.

Evaluation of clinical usefulness of HPV-16 and HPV-18 genotyping for cervical cancer screening.

OBJECTIVE: High-risk human papillomavirus (HR-HPV) infection is a leading cause of cervical cancer, of which human papillomavirus (HPV)-16 and HPV-18 account for about 70% of cases. Since HPV infection is common, it is important to focus on the HPV genotypes that pose the highest risk for effective cervical cancer screening. In this study, we evaluated the clinical usefulness of HPV-16/HPV-18 genotyping for cervical cancer screening. METHODS: A total of 86,022 women aged 25 years or older was analyzed in this study. Sensitivity, specificity, positive predictive value, and negative predictive value of HPV genotyping and cytology were analyzed. In addition, we subdivided participants into two groups according to cytology results, negative for intraepithelial lesion of malignancy (NILM) and atypical squamous cells of undetermined significance (ASC-US), and analyzed absolute risk (AR) and relative risk (RR) of cervical intraepithelial neoplasia (CIN) 3 or worse according to HPV genotype. RESULTS: The AR of CIN 3 or worse was 77.0 times higher in HR-HPV-positive compared to HR-HPV-negative. Compared to 12 other HR-HPV-positive, the AR of CIN 3 or worse was 4.2 times higher in HPV-16 and/or HPV-18 positive. This finding was more evident in women with NILM than in women with ASC-US. The RR of CIN 3 or worse was 7.0 in women with NILM and 4.5 in women with ASC-US. CONCLUSION: Regardless of the cytology results, the risk of CIN 3 or worse was higher in HPV-16/HPV-18 than in other HR-HPV. HPV-16/HPV-18 genotyping is recommended to screen women with a high risk of cervical cancer.

Measurement of serum total vitamin D (25-OH) using automated immunoassay in comparison [corrected] with liquid chromatography tandem-mass spectrometry.

BACKGROUND: The associations of vitamin D deficiency with many nonskeletal diseases are still being discovered. We evaluated the use of an automated immunoassay to measure serum total vitamin D (25-OH) and assessed vitamin D status in a Korean adult population. METHODS: We compared the Elecsys Vitamin D (25-OH) Total Assay (Roche Diagnostics) with liquid chromatography-tandem mass spectrometry (LC-MS/MS) using 300 serum samples. Total imprecision was calculated using three levels of quality control materials and serum samples. We also investigated the vitamin D status using data for 70,762 cases who had a routine health check-up in our hospitals. RESULTS: The regression equation: Elecsys = 0.882 × LC-MS/MS + 6.814 (r = 0.926). Total imprecision was within 10% for all quality control materials and serum samples. The prevalence of vitamin D deficiency using cut-off values of <50 nmol/l (<20 ng/ml) were 70.3% in males and 86.4% in females, respectively. The prevalence of vitamin D deficiency was higher in younger subjects than in older subjects (P for linear-by-linear association was <0.001). Serum vitamin D levels were highest in September and lowest in February. CONCLUSION: The Elecsys Vitamin D (25-OH) Total Assay was comparable to LC-MS/MS and appropriate for routine clinical use. Vitamin D deficiency is common in Korean adults.

Differences of the association of anti-Müllerian hormone with clinical or biochemical characteristics between women with and without polycystic ovary syndrome.

The aim of the present study was to compare the associations of anti-Müllerian hormone (AMH) with clinical or biochemical characteristics between women with and without polycystic ovary syndrome (PCOS). We also explored the optimal cutoff point of AMH to diagnose PCOS. A cross-sectional study was performed in 87 women diagnosed with PCOS and 53 healthy control subjects. Body mass index (BMI), indices of insulin resistance, metabolic syndrome-related variables, reproductive hormones and serum AMH were measured in all subjects. We conducted receiver operating characteristic (ROC) curve analysis to determine the cutoff of AMH for diagnosis of PCOS. Serum AMH levels were significantly (p <0.001) higher in women with PCOS after adjustment for age and BMI. AMH levels were not significantly related with obesity, indices of insulin resistance, and metabolic syndrome-related variables in both PCOS and control groups. In the control group, AMH levels showed positive correlations with total testosterone (p <0.001), free testosterone (p=0.024), and adiponectin (p=0.002), and showed negative correlations with age (p=0.010) and estradiol (E2) (p=0.012). However, only total (p=0.044) and free testosterone (p=0.012) levels showed significant positive correlations with serum AMH level in PCOS group. ROC curve analysis showed a cutoff point for AMH of 7.82 ng/mL (sensitivity 75.9%, specificity 86.8%) for diagnosis of PCOS. Differences of the association of AMH with clinical or biochemical characteristics between women with PCOS and control groups were observed. This might contribute to the pathogenesis of PCOS, although further investigation is necessary to elucidate the detailed mechanism.

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.

Dual-priming oligonucleotide-based multiplex PCR for the detection of Helicobacter pylori and determination of clarithromycin resistance with gastric biopsy specimens.

BACKGROUND: Assessment of Helicobacter pylori (H. pylori) clarithromycin resistance has rarely been performed routinely despite an increasing resistance rate. Our aim was to develop and evaluate the use of dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) to detect point mutations in the 23S rRNA gene responsible for clarithromycin resistance of H. pylori. MATERIALS AND METHODS: Gastric biopsy specimens from 212 untreated patients with dyspepsia were examined by culture, histology, and DPO-based multiplex PCR. A disk diffusion test and E-test were used for performing phenotypic antibiotic susceptibility tests. RESULTS: Among the biopsy specimens tested, 22.2% (47/212), 42.5% (90/212), and 41.5% (88/212) of the specimens were classified as H. pylori positive by culture, histology, and DPO-based multiplex PCR, respectively. Among 96 strains identified by either culture or DPO-based multiplex PCR, 80 strains were clarithromycin-susceptible and 16 strains (16.7%) were clarithromycin-resistant. There was 94.1% (32/34) concordance between phenotypic susceptibility tests and DPO-based multiplex PCR. In two patients with discrepant results, only DPO-based multiplex PCR detected clarithromycin-resistant strains. DPO-based multiplex PCR identified additional 49 clarithromycin-resistant or clarithromycin-susceptible H. pylori among 165 culture-negative specimens. CONCLUSIONS: DPO-based multiplex PCR can be used as a practical method for the detection of H. pylori infection and the determination of clarithromycin susceptibility in addition to phenotypic antimicrobial susceptibility tests.

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.

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.