[What medical technologists can do in disaster...--experiences and prospects--introduction].

Disasters in medical treatment are defined as, "Huge numbers of casualties are generated who cannot be accepted by regional medical facilities", and when more casualties are generated than the regions can accept it is a "Disaster", e.g. earthquake, typhoon or bus, train and aircraft accidents. Although the definition of disasters is invariable, recently, the actual disaster scale has been increasing along with changes in the living environment. Therefore, we should think seriously about what medical technologists should do first at a disaster base hospital in order to provide accurate lab data immediately after a disaster in which many patients are transported in a short time. In this symposium, the experiences and preliminary conditions in disasters were presented from the medical technologists' point of view at a disaster base hospital. Needless to say, the purpose of this symposium is to learn from simulations and experiences of disasters, to think what we should do under limited conditions, and to share information obtained from our experiences.

[Fundamental evaluation of apolipoprotein B-48 by chemiluminescence enzyme immunoassay--identification of apolipoprotein B-48 with immunoblotting].

BACKGROUND: Apolipoprotein B-48 (apo B-48) is a constituent of chylomicrons and chylomicron remnants, and its fasting concentration has been reported to be a marker of postprandial hyperlipidemia, which is thought to be a risk factor of atherosclerosis. AIM: We evaluated the serum apo B-48 concentrations by chemiluminescence enzyme immunoassay (CLEIA), which was recently introduced as Lumipulse f fully automated immunosaasy analyzer by Fujirebio Inc (Tokyo, Japan), and performed immunoblotting on agarose gel electrophoresis with anti-apo B-48 antibody. RESULTS: Apo B-48 assay was intra-assay reproducible (CVs: 1.9-3.1%) and inter-assay reproducible (CVs: 2.2-4.4%). The assay range for apo B-48 was from 0.2 to 40.0 microg/ml. The effects of interfering substances such as free/conjugated birirubin, hemoglobin, Intrafat, ascorbic acid and rheumatoid factor were negligible. For storage, it was preferable to freeze, and to avoid frozen-thaw process as much as possible. Anti-apo B-48 antibody was reactive over a wide range from origin to the position of very-low-density lipoproteins in immunoblotting after agarose gel electrophoresis. CONCLUSION: Apo B-48 measurement by CLEIA was feasible to clinical use for the assessment of lipoprotein metabolism.

[Contribution of medical technologists in team medical care of diabetics].

For the effective treatment of diabetic mellitus (DM), patients are encouraged to self-manage their disease according to the doctor's instructions and advice from certified diabetes educators (CDE) and other comedical staff. Therefore, the cooperation of medical staff consisting of a doctor, CDE, nurse, pharmacist, dietitian, and medical technologist is important for DM education. Medical technologists licensed for CDE (MT-CDE) have been participating in the DM education team in Kobe University Hospital since 2000. MT-CDE are in charge of classes for medical tests, guidance for self-monitoring of blood glucose and teaching how to read the fluctuation graph of the blood glucose level in the education program for hospitalized DM patients. MT-CDEs teach at the bedside how to read the results of medical tests during the first few days of hospitalization using pamphlets for medical tests. The pamphlets are made comprehensible for patients by using graphics and photographs as much as possible. It is important to create a friendly atmosphere and answer frank questions from patients, since they often feel stress when having medical tests at the early stage of hospitalization. This process of questions and answers promotes their understanding of medical tests, and seems to reduce their anxiety about having tests. We repeatedly evaluate their level of understanding during hospitalization. By showing them the fluctuation graph of the glucose level, patients can easily understand the status of their DM. When prescriptions are written on the graph, their therapeutic effects are more comprehensible for the patients. The items written on the graph are chosen to meet the level of understanding of each patient to promote their motivation. In summary, the introduction of MT-CDE has been successful in the education program for DM patients in our hospital. We plan to utilize the skills and knowledge of MT-CDE more in our program so that our DM education program will help patients cope with life with DM.

Performance evaluation and cross-reactivity from insulin analogs with the ARCHITECT insulin assay.

BACKGROUND: Insulin measurement is used for the diagnosis of hypoglycemia and for insulin pharmacokinetic evaluations. We assessed the analytical and clinical performance of the ARCHITECT insulin assay, a chemiluminescent immunoassay recently introduced for the ARCHITECT i2000 fully automated immunoassay analyzer (Abbott Laboratories). We also tested whether major insulin analogs cross-reacted with the immunoassay reagents. METHODS: We used Clinical and Laboratory Standards Institute protocols to assess the analytical performance of the ARCHITECT insulin assay and compared its accuracy with that of the E-test TOSOH II (IRI) from TOSOH Corporation. We used 3 recombinant insulin analogs (lispro, aspart, and glargine) to evaluate the cross-reactivity of insulin analogs with the ARCHITECT immunoassay reagent. RESULTS: The total CV for the ARCHITECT assay was < 5%. Correlation between the ARCHITECT insulin assay and the E-test TOSOH II (IRI) was satisfactory in the measured range, but we detected a slope deviation between the assays. The ARCHITECT insulin assay showed low cross-reactivity to the insulin analog aspart, whereas it detected the other insulin analogs, lispro and glargine, in concentrations as high as the theoretical concentrations. CONCLUSIONS: The ARCHITECT insulin assay showed favorable basic performance, including reproducibility, dilution linearity, detection limit, and effects of interfering substances. When interpreting results, clinicians and laboratory pathologists should be aware of the cross-reactivity of the ARCHITECT and other immunoassays to specific insulin analogs prescribed to diabetes patients.

The lipoprotein fraction between VLDL and LDL detected by biphasic agarose gel electrophoresis reflects serum remnant lipoprotein and Lp(a) concentrations.

We analyzed lipoprotein profiles in 616 Japanese by biphasic agarose gel electrophoresis using Chol/Trig Combo(TM) to yield HDL, VLDL, LDL and CM fractions which were stained with cholesterol and triglyceride reagents, respectively. To further evalute the pattern of electrophoresis, we analyzed the fraction between VLDL and LDL to confirm the possibility of a MidBand by using an automatic-five-fraction function. The cholesterol concentrations in MidBand (MidBand-C) showed a good correlation to remnant-like particle-cholesterol (RLP-C) (r = 0.95) in 23 consecutive samples (TC < 220 mg/dl, Lp(a) < 30 mg/dl). However, MidBand-C concentrations of subjects with high Lp(a) levels (Lp(a) > 30 mg/dl) were also high compared to RLP-C concentrations. The average MidBand-C levels in elderly normolipidemic control subjects (TC < 220, TG < 150) were 5.2 +/- 2.4 mg/dl in 30 males (mean age, 70 +/- 10 years) and 5.4 +/- 2.0 mg/dl in 40 females (64 +/- 11 years). The average MidBand-C levels of normolipidemic patients with coronary artery diseases (CAD; TC < 220, TG < 150) were 9.4 +/- 4.1 mg/dl in 126 males (mean age, 66 +/- 10 years) and 9.1 +/- 4.0 mg/dl in 44 females (67 +/- 10 years). These levels were significantly higher than control values (p < 0.0001). Areas under ROC curves were greater for MidBand-C than for TC, LDL-C and TG when used to discriminate between the patients with CAD and normolipidemic control subjects for each sex. There results suggest that the MidBand-C level may be useful as an indicator of risk for CAD.

[Usefulness of serum cystatin C for the diagnosis of impaired renal function].

Creatinine clearance (Ccr) is generally used as a halmark of glomerular filtration rate (GFR) in clinical medicine. Recently, it has been suggested that serum cystatin C measurement in serum reflects GFR. We compared serum cystatin C, serum creatinine, and serum beta2-microgrobrin in 70 patients with renal diseases in reference to creatinine clearance. The correlation between Ccr and 1/cystatin C was higher (r = 0.830) than that between Ccr and 1/serum creatinine (r = 0.789) or 1/serum beta2-microgroburin (r = 0.732). The levels of serum cystatin C in patients with Ccr ranging from 51 to 70 ml/min were significantly higher than those in patients with Ccr ranging more than 91 ml/min. Receiver-operated characteristic (ROC) analysis revealed that serum cystatin C showed the highest area under the curve among the three when Ccr = 90 ml/min was used as the cutoff point. We conclude that serum cystatin C is more useful than serum creatinine to detect early renal dysfunction.

[Usefulness of anti-cyclic citrullinated peptide antibodies (anti-CCP) for the diagnosis of rheumatoid arthritis].

Rheumatoid factor (RF) has been commonly used as a marker of rheumatoid arthritis (RA). RF can be detected in 60-80% of RA patients, but the specificity is low against other rheumatic diseases patients. We evaluated the diagnostic accuracy of anti-cyclic citrullinated peptide antibody (anti-CCP), a new diagnostic test for RA. Anti-CCP demonstrated higher sensitivity (81.0%) and specificity (92.4%). By the receiver operating characteristic (ROC) curve analysis, anti-CCP was superior to other markers (ie. RF, CARF, IgG-RF, and MMP-3). In early RA patients (RA patients who had had disease symptoms for < 2 years), sensitivity was 68.8%. Positivities of anti-CCP in RA patients became higher as the advance of stage defined by the Steinbrocker classification. We concluded that anti-CCP is a very valuable tool for the diagnosis of RA. Moreover, anti-CCP is a useful for finding RA of recent onset.

[Usefulness of examination of the cholesterol versus triglyceride ratio for lipoprotein fractions in a patient with marked hyper-triglyceridemia].

A patient consulted the emergency room with acute pancreatitis, hypertriglyceridemia, and diabetes mellitus, and was later admitted to the hospital. Serum levels of total cholesterol(TC) and total triglyceride (TTG), and the cholesterol(Chol) versus triglyceride(TG) ratio(Chol/TG) for lipoprotein fractions were examined periodically during the course of treatment using Chol/Trig Combo, which identifies Chol and TG by differential staining. On admission, the patient's TTG, pancreatic amylase and glucose levels were 4020 mg/dl, 2012 IU/l, and 242 mg/dl, respectively. Clinofibrate administration resulted in a decrease in Chol and TG values for all fractions. However, the Chol/TG ratios were unchanged(HDL of 0.2 to 0.4, VLDL of approximately 0.13, and LDL of 0.1 to 0.2: Reference values from 103 healthy students were as follows: HDL 5.8 +/- 2.0, VLDL 0.39 +/- 0.1, and LDL 4.9 +/- 1.3[Mean +/- SD].). During clinofibrate treatment, TC and TG values gradually increased. Clinofibrate was discontinued and fenofibrate administration was initiated. This was followed by a dramatic improvement in TC, TTG and Chol/TG values for both HDL and LDL. The monitoring of lipoprotein fraction values proved useful for determining the treatment regimen for this patient with hypertriglyceridemia.

[Comparative evaluation of serum HCV RNA by Roche Monitor Assay. Versions 1.0 and 2.0; as a predictive marker of subsequent response to IFN therapy].

Quantitative measurement of serum hepatitis C virus(HCV) RNA is important in predicting and monitoring interferon(IFN) therapy. We compared the sensitivity of HCV RNA measurement of different HCV genotypes between two available assays, Roche Monitor 1.0(v1.0) and Roche Monitor 2.0(v2.0). We also evaluated serum level of HCV RNA as the predictors of a long-term response to IFN therapy by distinguishing the complete responders(CR), partial responders(PR) and non-responders(NR) for IFN therapy. We quantified the serum HCV RNA levels in 151 patients and determined the genotypes; 96(64%) with genotype 1b(1b), 42(28%) with genotype 2a(2a), and 6(4%) was not identified. The relationship between the genotype and effects of IFN treatment was as follows: 23CR(1b:11, 2a:9), 15PR(1b:8, 2a:7), 20NR(1b:14, 2a:6). The RNA levels of 2a measured by v2.0 were significantly higher than those by v1.0(p < 0.05), although no significant difference was found in 1b between two assays. By using v2.0, when the cut-off level was set at 200 x 10(3) IU/ml before IFN therapy, CR was discriminated from PR, NR with a predicting efficiency of 88%. HCV RNA levels before IFN therapy were significantly lower in patients who became HCV RNA negative within 2 weeks than in patients who did at 4 weeks or longer. These results suggest that v2.0 is more sensitive and accurate than v1.0 for the quantification of 2a. Using v2.0 assay, it was shown that low viral titre at pretreatment and loss of viraemia within 2 weeks after treatment might be important markers for a long-term response to IFN therapy, irrespective of viral genotype. The v2.0 assay was found to be more useful in predicting effectiveness of IFN therapy.