Novel artificial stool material for external quality assurance (EQA) on a fecal immunochemical test for hemoglobin (FIT): The confirmed utility of stable hemoglobin and an internal standard material.

The fecal immunochemical test for hemoglobin (FIT), which detects lower gastrointestinal bleeding, is widely accepted for population-based colorectal cancer (CRC) screening programs. However, the FIT screening process has not been standardized yet, and standardizing the pre-analytical phase and establishing an external quality assurance (EQA) program compliant with ISO requirements is urgently needed. Although there have been various attempts to establish EQA materials suitable for FIT, no materials have yet been reported to have sufficient uniformity and acceptable immunochemical stability of hemoglobin (Hb).

The development of an artificial stool usable for the surveillance of faecal haemoglobin testing.

Background Faecal occult blood testing is an important diagnostic tool for the detection of colorectal cancer. However, it has not been standardized due to the absence of suitable specimens for surveillance. Methods We developed a ready-to-use artificial stool made from rice flour.

A Case of Waldenstrom Macroglobulinemia with Temporary Appearance of 7S IgM Half Molecule.

Background: We encountered a rare case of Waldenstrom macroglobulinemia with temporary appearance of 7S IgM half molecule and with monoclonal proteins binding to agarose gel.

Methods: The patient's serum and urine were analyzed using sodium dodecyl sulfate-polyacrylamide gel electrophoresis and immunoblotting. The N-terminal amino acid sequences of the IgM with abnormal mass (68 kDa) were determined and compared with those of known immunoglobulin.

Difference in bias approach for commutability assessment: application to frozen pools of human serum measured by 8 direct methods for HDL and LDL cholesterol.

Background: We used a difference in bias approach to evaluate the commutability of 4 frozen serum pools for 8 direct methods for measurement of HDL and LDL cholesterol (HDLC and LDLC).

Methods: Freshly collected nonfrozen sera from 138 diseased and 37 nondiseased patients and 4 frozen pools from the CDC Lipid Standardization Program were measured by direct methods and by the beta-quantification reference measurement procedure of the CDC. We used an error components model to estimate the difference in the bias component of error plus its uncertainty for frozen pools vs patient samples between the direct method and the reference procedure.

Evaluation of four different equations for calculating LDL-C with eight different direct HDL-C assays.

Background: Low-density lipoprotein cholesterol (LDL-C) is often calculated (cLDL-C) by the Friedewald equation, which requires high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG). Because there have been considerable changes in the measurement of HDL-C with the introduction of direct assays, several alternative equations have recently been proposed.

Methods: We compared 4 equations (Friedewald, Vujovic, Chen, and Anandaraja) for cLDL-C, using 8 different direct HDL-C (dHDL-C) methods.

The relationship between oxidized lipoprotein(a) and carotid atherosclerosis in asymptomatic subjects: a comparison with native lipoprotein(a).

Background: Oxidized lipoprotein(a) (oxLp(a)) can be a more potent marker of atherogenesis than native Lp(a), although Lp(a) is considered to be a risk factor for atherosclerotic diseases. Limited clinical data are available regarding the significance of oxLp(a) in atherosclerotic manifestations. This study aimed to investigate the association between the serum oxLp(a) and carotid artery intima-media thickness (CIMT), in comparison to the serum Lp(a) levels, among asymptomatic subjects.

Non-HDL cholesterol shows improved accuracy for cardiovascular risk score classification compared to direct or calculated LDL cholesterol in a dyslipidemic population.

Background: Our objective was to evaluate the accuracy of cardiovascular disease (CVD) risk score classification by direct LDL cholesterol (dLDL-C), calculated LDL cholesterol (cLDL-C), and non-HDL cholesterol (non-HDL-C) compared to classification by reference measurement procedures (RMPs) performed at the CDC.

Methods: We examined 175 individuals, including 138 with CVD or conditions that may affect LDL-C measurement. dLDL-C measurements were performed using Denka, Kyowa, Sekisui, Serotec, Sysmex, UMA, and Wako reagents.

The association between blood glucose and oxidized lipoprotein(a) in healthy young women.

Background: Oxidized lipoproteins play important roles in the atherosclerotic processes. Oxidized lipoprotein(a) (oxLp(a)) may be more potent in atherosclerotic pathophysiology than native Lp(a), a cardiovascular disease-relevant lipoprotein. Increased blood glucose concentrations can induce oxidative modification of lipoproteins.

Seven direct methods for measuring HDL and LDL cholesterol compared with ultracentrifugation reference measurement procedures.

Background: Methods from 7 manufacturers and 1 distributor for directly measuring HDL cholesterol (C) and LDL-C were evaluated for imprecision, trueness, total error, and specificity in nonfrozen serum samples.

Methods: We performed each direct method according to the manufacturer's instructions, using a Roche/Hitachi 917 analyzer, and compared the results with those obtained with reference measurement procedures for HDL-C and LDL-C. Imprecision was estimated for 35 runs performed with frozen pooled serum specimens and triplicate measurements on each individual sample.

A novel missense mutation of ABCA1 in transmembrane alpha-helix in a Japanese patient with Tangier disease.

Tangier disease (TD) is a hereditary disorder characterized by the severe deficiency or absence of high-density lipoprotein cholesterol (HDL-C). TD is caused by mutations in the ATP-binding cassette transporter A1 (ABCA1) gene, most of which are located in the extracellular loops and nucleotide-binding domains. Here we describe the first case of TD carrying a missense mutation in a transmembrane alpha-helix of ABCA1.

Novel automated pulse immunoassay for human alpha-fetoprotein.

Background: To improve current alpha-fetoprotein (AFP) assays, which are expensive and time-consuming, a specific AFP reagent has been developed for practical use in our newly developed high-speed, highly sensitive pulse immunoassay (PIA) system, in which a latex immunoagglutination reaction is carried out under a high-frequency pulse voltage, leading to an enhanced immunological reaction.

Methods: We evaluated the assay performance (reproducibility, sensitivity, dilution linearity, interference) of the newly developed automated AFP PIA compared with the current AFP assay.

Results: Using pooled serum samples, the within-run reproducibility resulted in a correlation variation of 3.

Evaluation of a gel-permeation high-performance liquid chromatography for determining triglyceride levels in serum major lipoproteins, compared with the ultracentrifugation/precipitation method.

Objectives: To evaluate the gel permeation high-performance liquid chromatography (GP-HPLC) method for determination of triglyceride (TG) levels in low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Design And Methods: The GP-HPLC and the ultracentrifugation (UC)/precipitation methods were used and compared.

Results: There was no significant difference in measured levels of LDL-triglyceride between the two methods, but the HDL-triglyceride levels measured by the GP-HPLC technique were significantly higher than the UC/precipitation one (145+/-47 mg/L and 121+/-45 mg/L respectively, n=38, p<0.

Higher frequency of abnormal serum angiopoietin-like protein 3 than abnormal cholesteryl ester transfer protein in Japanese hyperalphalipoproteinemic subjects.

Background: Either a decrease of cholesteryl ester transfer protein (CETP) or an increase of angiopoietin-like protein 3 (ANGPTL3) in plasma has been shown to increase HDL-cholesterol (HDL-C) levels. However, as yet, it is not known which protein is more strongly associated with the modulation of HDL in the Japanese hyperalphalipoproteinemic (HALT) subjects.

Methods: The serum concentration of ANGPTL3 and CETP, together with total cholesterol (TC), triglycerides (TG), adiponectin and ApoE phenotypes were determined in three groups with different HDL-C concentrations: low, <40 mg/dl (n=51); normal, 40-90 mg/dl (n=126) and high, >90 mg/dl (n=89) in the average Japanese population.

[Evoked potential monitoring in an operation of neurosurgery].

In the neurosurgical field, the evoked potential is employed for the monitoring of intraoperative nerve function. During evoked potential monitoring, surgical manipulation-related nerve dysfunction is detected, and functional localization/nerves in the cerebral cortex are identified to prevent postoperative neurological complications. It is important to reduce the contact resistance to 2 kOmega or less on the application of plate electrodes used for recording and prevent noise by bundling electrode leads, to ensure a stable evoked potential during surgery.

Serodiagnosis of Mycobacterium avium-complex pulmonary disease using an enzyme immunoassay kit.

Rationale: The diagnosis of Mycobacterium avium-complex pulmonary disease (MAC-PD) and/or its discrimination from pulmonary tuberculosis (TB) is sometimes complicated and time consuming.

Objectives: We investigated in a six-institution multicenter study whether a serologic test based on an enzyme immunoassay (EIA) kit was useful for diagnosing MAC-PD and for distinguishing it from other lung diseases.

Methods: An EIA kit detecting serum IgA antibody to glycopeptidolipid core antigen specific for MAC was developed.

Serum remnant lipoprotein cholesterol/triglyceride ratio as an index for screening familial type III hyperlipidaemia.

Background: An elevated serum remnant lipoprotein cholesterol (RLP-C)/triglyceride (TG) ratio has not been evaluated as an index of familial type III hyperlipidaemia defined by the presence of beta-VLDL and apolipoprotein (Apo) E2/2 phenotype in the Japanese hyperlipidaemic population.

Methods: Serum lipids and lipoproteins from 514 individuals (200 men and 314 women, mean age 58 years) with total cholesterol >6.22 mmol/L and TG between 2.

An immunoglobulin A1 that inhibits lactate dehydrogenase activity, with reversal of inhibition by addition of NADH.

We discovered a patient with low serum lactate dehydrogenase (LD) activity and an abnormal LD isozyme pattern. We analyzed the patient's LD inhibitor using electrophoresis, affinity chromatography, and immunochemical technologies. The LD activity of the patient's serum was inhibited more strongly at 4 degrees C than at 37 degrees C.

[Evaluation of samples that indicated the difference of immunoglobulin values between different assays].

Since the immunoglobulin levels of survey samples for the survey of Japanese Association of Medical Tech7ologists in 2003, especially the IgA and IgM, became different by the immunological methods (LAIA [latex agglutination immunoassay] and TIA [turbidimetric immunoassay]), the cause of difference was investigated. From the results of gel filtration and immunoblotting analysis, it was suggested that profiles of the reaction of purified IgA and IgM polymers in survey samples were different on each method. In the case of M protein, also, there were higher levels of IgM and IgA type M protein by TIA and SRID methods than other methods even though the precipitation curve was obscure.

[Future outlook for OTC examination (test)].

As the primary prevention of disease has been emphasized, there may be a growing need for well-conditioned development and spread of OTC test equipment, OTC test reagent and remote healthcare. Some typical examples of "simple and rapid examination items, which can be done at home by established technology" are explained in this paper and may be required in the near future by the whole Japanese population with a view to the current status of OTC test and the coming relaxation of governmental regulation. The reasons why these examination items should be commercialized as Switch OTC and the epidemiological background are further discussed.