Assessment of average of normals (AON) procedure for outlier-free datasets including qualitative values below limit of detection (LoD): an application within tumor markers such as CA 15-3, CA 125, and CA 19-9.

Average of normals (AON) is a quality control procedure that is sensitive only to systematic errors that can occur in an analytical process in which patient test results are used. The aim of this study was to develop an alternative model in order to apply the AON quality control procedure to datasets that include qualitative values below limit of detection (LoD). The reported patient test results for tumor markers, such as CA 15-3, CA 125, and CA 19-9, analyzed by two instruments, were retrieved from the information system over a period of 5 months, using the calibrator and control materials with the same lot numbers. The median as a measure of central tendency and the median absolute deviation (MAD) as a measure of dispersion were used for the complementary model of AON quality control procedure. The ubias values, which were determined for the bias component of the measurement uncertainty, were partially linked to the percentages of the daily median values of the test results that fall within the control limits. The results for these tumor markers, in which lower limits of reference intervals are not medically important for clinical diagnosis and management, showed that the AON quality control procedure, using the MAD around the median, can be applied for datasets including qualitative values below LoD.

Ischemia-modified albumin and advanced oxidation protein products as potential biomarkers of protein oxidation in Alzheimer's disease.

BACKGROUND: The aim of the present study was to determine the systemic levels of oxidative stress markers, such as ischemia-modified albumin (IMA), advanced oxidation protein products (AOPP), ferric reducing antioxidant power (FRAP) and the prooxidant-antioxidant balance (PAB), to clarify protein redox homeostasis in patients with Alzheimer's disease, and to compare them with mentally healthy persons of the same age. METHODS: A total of 38 patients with Alzheimer's disease (AD) and 34 sex- and age-matched mentally healthy control subjects were included in this study. RESULTS: The patients had significantly higher AOPP, IMA and PAB in the patient group than in the control group (P = 0.004, P = 0.001, P = 0.007, respectively). The FRAP was significantly lower in the patients with AD than in the control subjects (P = 0.002), and according to the receiver operating characteristic curves, the IMA and AOPP areas are below the 0.700 receiver operating characteristic curve line (area under the curve 0.817 and 0.730, respectively; 95% CI 0.709-0.898 and 0.612-0.828, respectively). CONCLUSIONS: Increased IMA, AOPP and PAB, and decreased FRAP are likely to be results of oxidative stress, a condition in which an imbalance occurs between the production and inactivation of reactive oxygen species in AD. The IMA could be used for the better evaluation of clinical status, as well as the independent characteristic symptoms of AD, for the purposes of routine clinical laboratory analysis.