An evaluation of the performance of the Point of Care Test iCHROMA™ AFP method: Precision and accuracy

The estimation of serum alpha-fetoprotein (AFP) is useful in the diagnosis and monitoring of primary hepatocellular carcinoma, hepatoblastoma, non-seminomatous testicular germ cell tumours and other germ cell tumours. The iCHROMA™ AFP is a lateral flow chromatography, fluorescence immunoassay (FIA) for the quantitative determination of AFP in serum or plasma. In this study, the Boditech iCHROMA™ AFP assay had a very good precision of 9.8%. It showed a very good correlation with the following 12 methods: Abbott Architect (r2 = 0.9705), BioMerieux VIDAS (r2 = 0.9717), Roche Cobas 6000/8000 (r2 = 0.9738), Siemens Centaur XP/XPT/Classic (r2 = 0.9654), Siemens/DPC/Immulite 2000/2500 (r2 = 0.9673), Siemens/DPC/Immulite 1000 (r2 = 0.9670), Beckman Dxl 600/800 (r2 = 0.9676), Roche Elecsys (r2 = 0.9683), Roche Cobas 4000/e411 (r2 = 0.9688), Roche Modular E170 (r2 = 0.9692), SNIBE Maglumi (r2 = 0.9457) and Ortho Vitros 3600/5600/ECi (r2 = 0.9714). In summary, the iCHROMA™ AFP, a rapid point of care test method, has a within-run precision value of less than 10% and excellent correlations with traditional laboratory methods. There is a consistent overestimation with the iCHROMA™ method, which must be taken into consideration when setting a reference range.

Parental occupational exposures in wood-related jobs and risk of testicular germ cell tumours in offspring in NORD-TEST a registry-based case–control study in Finland, Norway, and Sweden

Objective We assessed the association between parental prenatal exposures in wood-related jobs and risk of testicular germ cell tumours (TGCT) in offspring. Methods NORD-TEST, a registry-based case–control study in Sweden, Finland and Norway, included 8112 TGCT cases diagnosed at ages 14–49 years between 1978 and 2012 with no history of prior cancer, and up to four controls matched to each case on year and country of birth. Parents of cases and controls were identified via linkages with the population registries and their occupational information was retrieved from censuses. The Nordic Occupational Cancer Study Job-Exposure Matrix was used to assign occupational exposures to each parent. Logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (CI). Results Maternal wood-related job was not associated with the risk of TGCT in offspring (OR 1.08, CI 0.55–2.14), while paternal wood-related job was associated with a decreased risk of TGCT in offspring (OR 0.85, CI 0.75–0.96). None of the specific wood-related jobs, such as upholsterers, sawyers, or construction carpenters, were significantly associated with a risk of TGCT. Only exception was observed in a sensitivity analysis which showed an increased risk in the small group of sons of fathers working as ‘cabinetmakers and joiners’ the year before conception (OR of 2.06, CI 1.00–4.25). Conclusion This large-scale NORD-TEST analysis provided no evidence of an association between parental prenatal exposures in wood-related jobs and TGCT in sons.

Associations of serum levels of microRNA-371a-3p (M371) with risk factors for progression in nonseminomatous testicular germ cell tumours clinical stage 1

Purpose Lymphovascular invasion (LV1) and presence of > 50% embryonal carcinoma (> 50% EC) represent risk factors for progression in patients with clinical stage 1 (CS1) nonseminomatous (NS) testicular germ cell tumours. As serum levels of microRNA-371a-3p (M371) are capable of detecting small amounts of GCT, we evaluated if LV1 and > 50% EC are associated with M371 levels. Methods M371 serum levels were measured postoperatively in 153 NS CS1 patients and both pre- and postoperatively in 131 patients. We registered the following factors: age, tumour size, LV status, > 50% EC, teratoma in primary, preoperative elevation of classical tumour markers. M371 expression was compared among subgroups. The ability of M371 to predict LV1 was calculated by receiver operating characteristics (ROC) curves. Multiple regression analysis was used to look for associations of M371 levels with other factors. Results Postoperatively elevated M371 levels were found in 29.4% of the patients, but were neither associated with LV status nor with > 50% EC. Likewise, relative decrease of M371 was not associated. ROC analysis of postoperative M371 levels revealed an AUC of 0.5 for the ability to predict LV1 while preoperative M371 had an AUC of 0.732. Multiple regression analysis revealed significant associations of preoperative M371 levels with LV status (p = 0.003), tumour size (p = 0.001), > 50% EC (p = 0.004), and teratoma component (p = 0.045). Conclusion Postoperatively elevated M371 levels are not associated with risk factors for progression in NS CS1 patients. However, the significant association of preoperative M371 expression with LV1 deserves further evaluation.