The life of a disaster victim is affected by the scale of the disaster. The deep vein thrombosis (DVT) medical examination is important for venous thromboembolism (VTE) prevention from the aspect of secondary disaster prevention. Its procedure at disaster sites is different from a clinical-setting procedure, but performing DVT medical examination as a screening method by leg echocardiography, which does not burden a patient, is effective. Kumamoto earthquake gave us a check-up result of the DVT medical examination beyond 3,500 people. A risk factor for DVT is also indicated, and it is desirable that a leg echocardiography will be utilized from now on. The necessity of DVT medical examination is determined by the life environment including that in a vehicle. It is desirable to reduce the risk factor by improving the shelter environment, which leads to the reduction in the severity of VTE in a patient without performing DVT medical examination.

Urine provides much information concerning illness and is easily collected noninvasively. Qualitative and quantitative urinalyses are primarily carried out with an autoanalyzer. In urine qualitative tests using the autoanalyzers, the coloration of a urine test paper is measured under a reflected light and it is converted into a qualitative or semiquantitative value and reported rapidly. On the other hand, in urine quantitative tests using autoanalyzers, which use a standard parameter for the first measurement, the results of a sample with abnormally high levels of protein and glucose takes a longer time to obtain. The results of qualitative and quantitative tests using different autoanalyzers are reported separately without being shared. A rapid test after urine collection is important for urinalysis, and a urine qualitative test is usually carried out first. Therefore, in a quantitative test, the urine test paper reflectance data obtained in the qualitative test can be used and shared through a host computer. This measurement logic for predicting the result of a urine quantitative test of a sample that is beyond the measurement range was developed from the analysis of the reflectance of a urine test paper. Moreover, the feedforward technique for selecting the measurement parameter of an autoanalyzer using this measurement logic was studied. The measurement method can be used to report the results on the levels of protein (891 cases) and glucose (171 cases) in all urine samples on the basis of initial results. The urine quantitative measurement method using the reflectance of the urine test paper is useful for the rapid measurement of samples with abnormally high levels of protein and glucose.

The platelet aggregation test has been mainly carried out using dedicated semiautomated analyzers. In our hospital, the platelet aggregation test is carried out using a whole blood aggregometry, WBA Analyzer (TAIYO Instrument Inc.) to assess the clinical efficacy of antiplatelet drugs. Recently, the fully automated coagulation analyzer CS-2100i (Sysmex Corporation) has been upgraded to perform both the platelet aggregation test and coagulation test simultaneously. Only the manual preparation of platelet-rich and platelet-poor plasmas is required, and other processes are performed automatically by CS-2100i. Our basic evaluation showed good performance results. We concluded that CS-2100i can assess the clinical efficacy of antiplatelet drugs as well as the WBA analyzer does using the maximal aggregation (%) results of the ADP test (1 and 10 μM). At present, the platelet aggregation test is carried out at limited clinical laboratories. Since the CS series has already been installed in many clinical laboratories, we expect that the platelet aggregation test by the CS series will promote the standardization of the platelet aggregation test and lead to improvement in the efficacy assessment of antiplatelet drugs.

We examined the availability of prothrombin time (PT) and activated partial thromboplastin time (APTT) for monitoring the anticoagulant effects of dabigatranetexilate, a direct inhibitor of thrombin. We measured PT and APTT of 10 healthy volunteers before and after taking dabigatran (150 mg twice daily) using some reagents. In the comparison of APTT results, we used three units: number of seconds, APTT prolonged ratio, and APTT ratio. To determine APTT prolonged ratio, we divided the number of APTT seconds after the administration of dabigatran by the number of APTT seconds before administration. On the other hand, APTT ratio is obtained by dividing the number of APTT seconds of each subject by that of normal plasma. Our test results suggest that APTT is more useful for monitoring the anticoagulation effect of dabigatran. When we assess these results, differences in the unit of APTT prolonged ratio between reagents are smaller than those in unit of seconds. However, it is cumbersome to determine the APTT prolonged ratio of respective patients. Thus, we assessed the APTT ratio as a solution, and then obtained the equivalent outcome to the APTT prolonged ratio. In general, we measure APTT in seconds to monitor the anticoagulation effect of dabigatran. However, it is suggested that the APTT prolonged ratio can help correct the differences in APTT results between reagents (facilities).

The Bethesda System (TBS) and the guideline based on TBS clearly indicate the clinical management of cases with atypical “indefinite for dysplastic or malignant” cells by defining the categories of “atypical squamous cells (ASC)” and “atypical glandular cells (AGC)”. However, there still remain some cases with atypical metaplastic cells that are difficult to categorize on the basis of TBS. In this study, we tried to find the discrepancies in the diagnoses of atypical metaplastic cells between diagnosticians, and discussed the problems. Four pathologists and twenty cytotechnologists (CT) in five hospitals independently diagnosed different photo slides of eighteen atypical metaplastic cells on the basis of TBS, and the results of the diagnoses were statistically analyzed. Correlations between the diagnoses of each pathologist and CT were quite low. The kappa coefficients ranged from −0.17 to 0.39, and poor or fair agreement did not correlate with experience or specialty. In this study, the correlation of the present TBS-based diagnoses of atypical metaplastic cells was quite poor between diagnosticians. Recent reports indicate high-risk human papillomavirus (HPV) infection in atypical immature metaplasia of the uterine cervix; thus, it seems important to discuss the diagnostic criteria and clinical management of these atypical metaplastic cells.

We investigated the recent prevalence of intestinal parasites in companion animals in Saitama Prefecture, Japan. Between January 2008 and November 2016, fecal samples were collected from 1,290 dogs and 422 cats in public animal shelters and examined by microscopy. Overall, the prevalences of intestinal parasites in dogs and cats were 23.0% and 51.2%, respectively. In dogs, Trichuris vulpis was the most prevalent parasite species (15.1%), followed by Ancylostoma caninum (6.4%), Toxocara canis (2.1%), Spirometra erinaceieuropaei (2.0%), Isospora ohioensis (1.3%), Giardia intestinalis (0.5%), Cryptosporidium canis (0.5%), Toxascaris leonina (0.2%), Dipylidium caninum (0.2%), Pentatrichomonas hominis (0.2%), Hymenolepis diminuta (0.1%), Diphyllobothrium nihonkaiense (0.1%), and Isospora canis (0.1%). However, in cats, Ancylostoma tubaeforme was the most prevalent parasite species (25.1%), followed by S. erinaceieuropaei (18.2%), Toxocara cati (17.8%), Pharyngostomum cordatum (6.9%), Isospora felis (5.2%), D. caninum (1.9%), Capillaria sp. (1.7%), Isospora rivolta (1.4%), Cryptosporidium felis (0.7%), Taeniidae (0.5%), and Toxoplasma gondii (0.2%). Molecular analyses were performed, and the Toxoplasma species from a cat was identified as T. gondii, and the Cryptosporidium species in dogs and cats were identified as C. canis and C. felis, respectively. Moreover, blood samples were collected from 1,435 cats in public animal shelters between April 2000 and November 2015 and serum antibodies to T. gondii were examined. Among these cats, 75 (5.2%) were positive for this antibody. As most of these parasites have zoonotic potential, current data on parasite dissemination among animal companions are of great importance.

<Objectives> The American Society of Clinical Oncology/College of American Pathologists guideline was revised in 2013 (2013 ASCO/CAP guideline). The aim of this study is to elucidate how the 2013 ASCO/CAP guideline affects current clinical breast cancer practice. <Methods> From April 2014 to March 2016, we collected the results of HER2-FISH tests for breast cancer by biopsies from 226 cases. On the basis of the 2013 ASCO/CAP guideline, we reevaluated the results of HER2-FISH tests and compared them with those of original reports. We also investigated the results of immunohistochemical analysis of estrogen receptor (ER), progesterone receptor (PgR), and HER2. <Results> Of the 226 cases, 37 (16.4%) were determined as positive on the basis of the 2013 ASCO/CAP guideline. Two of the 37 positive cases had HER2/CEP17 ratios of less than 2.0, but HER2 copy numbers were more than 6.0, which were previously negative. Twenty-four (10.6%) cases were equivocal. Among these cases, 3 were triple negative [ER (−), PgR (−), HER2 (−)] breast cancers. <Conclusions> The 2013 ASCO/CAP guideline increased the number of additional positive and equivocal cases in HER2-FISH tests, which were diagnosed as negative on the basis of the previous guideline. A non-negligible number of cases became equivocal on the basis of the 2013 ASCO/CAP guideline. In addition, 3 (12.5%) cases that were diagnosed as “triple negative” on the basis of the previous criteria might be candidates for HER2-targeted therapy if diagnosed on the basis of the 2013 ASCO/CAP guideline. Our data suggest that the 2013 ASCO/CAP guideline can increase the number of patients receiving HER2-targeted therapy.

For parathyroid hormone (PTH) measurement, serum and plasma are used as specimens. When serum was used as a specimen, we found a case that showed a lower measured PTH level than when EDTA-2Na plasma was used. Therefore, the reason for the decrease in the measured PTH level was determined. Using specimens collected from 10 healthy adults, we analyzed the effects of the following on the measured whole PTH level: the type of blood collection tube used, the drug added to the blood collection tube, the number of times a specimen was transferred to a sample cup, the contact area between the sample and the sample tube, and the material of the sample tube. When using a rapid-clotting blood collection tube, the measured whole PTH level was significantly lower than that when using other types of blood collection tubes. Since thrombin decreased the measured whole PTH level in a concentration-dependent manner, the measured whole PTH level was considered to be decreased by thrombin added to the rapid-clotting blood collection tube. Depending on the number of times a specimen was transferred to a sample cup and the contact area between the specimen and the sample tube, the measured whole PTH level decreased. This result suggests that PTH was adsorbed to the plastic tube. Furthermore, the rate of decrease in the measured whole PTH level varies depending on the material of the sample tube, and in the specimen used, i.e., serum or EDTA-2Na plasma. A difference in the rate of decrease with respect to the sample tube of the same material was recognized.

Urine smear (Gram stain) analysis is a rapid diagnostic method for urinary tract infection (UTI). At present, an automated urine analyzer with enhanced bacterial identification function is expected to be used as a screening tool. Here, we evaluated the performance of the automated urine particle analyzer UF-5000 (Sysmex), which has an enhanced function to identify bacterial Gram stainability (BACT-info), compared with conventional methods including Gram staining and quantitative bacterial culture. A total of 188 urine samples from suspected UTI patients were used and 179 were feasibly UTI. UF-5000 results were 83.2% in agreement with Gram staining results and 81.0% in agreement with culture results, whereas the agreement of Gram staining with culture results was 85.1%. Gram-negative results obtained with UF-5000 exhibited a high positive predictive value (93.3%) for both Gram staining and culture results. An insufficient judgement algorithm in UF-5000 may be responsible for some discordant results. UF-5000 using BACT-info shows great promise in screening for UTI pathogens.

In this study, we evaluated the performance of XN-3000, an automated hematology analyzer, in measuring cell count in cerebrospinal fluid samples. The coefficients of variation (CV) and mean value in the test for within-run reproducibility for total WBC count were 2.1% (103 cells/μL) and 6.2% (25 cells/μL), respectively. The limit of detection was estimated to be 2 cells/μL. The regression equations for the counts of total WBCs, mononuclear cells, and polymorphonuclear cells between XN-3000 (y) and the visual observation method using the Fuchs–Rosenthal counting chamber (x) were y = 0.96x + 1.51 (r = 0.997), y = 0.98x (r = 0.995), and y = 0.95x + 1.18 (r = 0.999), respectively. The results showed almost good correlations. In the scattergram, the cluster of Cryptococcus spp. was displayed in a debris area, which enabled the precise cell count. Furthermore, we may detect Cryptococcus spp. by using an automated analyzer. Measurement with an automated analyzer is useful, especially in the evening and during holidays, and anybody can report an examination result quickly and correctly.

There is currently no analytical device for conducting the rapid antimicrobial susceptibility test (AST). DPS192iX is a new commercial antimicrobial susceptibility analyzer. We evaluated the performance of DPS192iX for rapid AST. We used 199 isolates of gram-negative Enterobacteriaceae for analysis. We measured the minimum inhibitory concentration (MIC) at 6, 7 and 8 hours and 18 hours from the start of AST. Then, we compared the coincidence rates of MIC and interpretive categories. The percentages at which the MICs matched at 6, 7 and 8 hours were 66.4%, 69.3% and 71.0%, respectively. The agreement rates of interpretive categories after 6, 7 and 8 hours and 18 hours of culture were 87.4%, 88.7% and 90.2%, respectively. Then the proportions of very major errors at 6, 7 and 8 hours were 23.1%, 17.7% and 15.4%, respectively. The major error rates were 2.6%, 2.3% and 2.0%. The results of the rapid AST showed high agreement with the final results. Moreover, there was almost no discrepancy in the results. In conclusion, we have shown that DPS192iX may contribute to rapid AST.

I aimed to develop an individual quality control system using individual biological variations and past personal plural clinical test values. Therefore, I developed a computing system that could search for past clinical test values instantly by the index retrieval method to reduce the traffic load to the in-hospital network system. I used a logic to detect test errors and random errors using standard deviation, a quartile deviation of personal plural clinical test values, and previous-result check. In the result of the comparison experiment of the access time by computer simulation, the index retrieval method was more instantaneous than the sequential search method. The access times of the search system were less than 0.001 to 0.671 seconds in all test items and 0.025 to 0.119 seconds on average for each retrieval target item in routine laboratory tests conducted approximately 4 months previously. The warning appearance ratio by the method using the respective individual biological variations, which used the standard deviation index (SDI) and the quartile deviation index (QDI), was in the range from 4.55 to 6.35%. The rate of detection of test errors was 3.83 to 6.90% in routine laboratory tests conducted approximately 1 year previously. It was effective for the reduction of useless retest and test errors.

Creatinine concentration is a useful index for evaluating renal function. Therefore, the method used for its measurement must afford high precision and reliability. In this study, we compared the measurement error for creatinine concentration determined by the enzyme method using six reagents. In the accuracy test conducted using JCCRM521-12, aqua-auto KINOS CRE-III plus and CicaLiquid N-CRE showed a negative error at an intermediate creatinine concentration; the bias from the certified value deviated from the theoretical tolerance limit of ±4.8%. All reagents showed linearity up to 140.24 mg/dL. However, theoretical tolerance limit evaluation showed curves with different trends for each reagent; Serotec CRE-N was the only reagent that met the theoretical tolerance limit of ±5.0% in the entire concentration range investigated. The effects of various coexisting substances such as dihydric phenol drugs and the M protein were also investigated. The mechanisms by which the effects were exerted varied depending on the reagent, and the presence and extent of effects may differ depending on the composition of each reagent (e.g., surfactant), salt concentration, and pH. Reagents have been continuously improved by their manufacturers, enabling accurate measurements with small errors. However, in this study, we found that the curvature of linearity and the effects of coexisting substances and drugs are error factors, and the degree and tendency of effects vary depending on the reagent. Hence, it is necessary to understand and pay attention to the characteristics of the reagent used in the laboratory.

We conducted a basic examination of a cortisol-measuring reagent by chemiluminescent immunoassay as a principle, which was newly developed as a reagent for the AIA-CL system (Tosoh Co., Ltd.). The coefficients of variances (CVs) for intra- and inter-assays using control samples were between 2.3 and 5.8%. They showed good linearity from 0 to 60.0 μg/dL, and the limit of quantitation was 0.65 μg/dL. This new method is characterized by a reduction in the measurement time and an increase in the specificity related to monoclonal antibody switching from a polyclonal antibody. This improves the cross-reactivity with synthetic steroids, which has been a limitation, suggesting that intrinsic cortisol can be measured more accurately by this new method than by the conventional method. This method may be useful for routine examinations.

Procalcitonin (PCT) is an important marker for the diagnosis of bacterial sepsis. In this study, we evaluated the basal performance of the recently developed PCT kit “Lumipulse Presto Brahms PCT”. The obtained within-run and between-day precisions were 1.1–2.0% and 3.3–3.5%, respectively. The obtained diluted linearity and lower limit of detection were 90.00 ng/mL and 0.003 ng/mL, respectively. Interference analysis showed that only RF negatively affected the assay results. PCT levels decreased to 14% at 24 hours and room temperature, in contrast to 5% at 4°C. The correlation coefficient (r) between this assay and the conventional assay was 0.991. The basal performance of the PCT kit is satisfactory and it could be used for measurement with high sensitivity. Results suggest that this kit is useful for the diagnosis of bacterial sepsis.

We report on a case of bloodstream infection (BSI) caused by Leptotrichia goodfellowii in a patient with hematological malignancy. A 77-year-old male patient with angioimmunoblastic T-cell lymphoma was admitted to our hospital for salvage chemotherapy. Because of neutropenia caused by previous chemotherapy, the patient had received oral levofloxacin prophylaxis before hospitalization. He developed a fever of 39°C after 2 days of hospitalization; intravenous cefepime was administered and the fever resolved. An isolate from a blood culture, which was collected at the time of fever from the patient, was positive only in the anaerobic culture bottle; Gram staining revealed spindle-shaped gram-negative rods. Bacterial growth was observed on Brucella HK agar (Kyokuto Pharmaceutical) after 48-hour anaerobic incubation. Leptotrichia buccalis was identified using BBL Crystal ANR (Becton Dickinson); however, some results of the analysis were different from the biochemical characteristics of L. buccalis. Finally, it was identified genetically as L. goodfellowii by partial 16S rRNA gene sequencing analysis. It has been reported that this Leptotrichia species caused BSI in patients with hematological malignancies during chemotherapy. For cases of BSI in patients with immunocompromising conditions and blood culture findings of large and spindle-shaped gram-negative rods, it is necessary to consider this species as one of the pathogenic bacteria. In addition, BSI caused by this Leptotrichia species has a good prognosis; resistance to antimicrobials used for general anaerobic bacteria and β-lactamase-producing strains has not been reported. Accordingly, the BSI in our patient was cured by antimicrobial therapy with intravenous cefepime, although levofloxacin was ineffective.

Background: Metastasis of cancers to the thyroid gland is rare. Renal cell carcinoma is the most frequent source of metastatic cells to the thyroid gland. We report a case of DPP IV-positive metastatic renal cell carcinoma to the thyroid gland. Case: A 50-year-old woman had undergone a right radical nephrectomy for clear cell renal cell carcinoma in November 2009. The patient presented with a 2-cm solitary palpable mass in the right lower pole of the thyroid gland on ultrasonography in September 2014. Fine needle aspiration cytology showed cell clusters and isolated cells with large and hyperchromatic nuclei of varying sizes, conspicuous nucleoli, and abundant granular cytoplasm. Tumor cells showed strong staining of DPP IV. The cytological diagnosis was poorly differentiated carcinoma. The patient underwent a right thyroid lobectomy. The histopathological diagnosis was metastatic clear cell renal cell carcinoma. Conclusion: Differential diagnosis of primary and metastatic thyroid carcinomas is often difficult. DPP IV staining of cytological specimens is a supplemental marker for distinguishing thyroid carcinoma from benign thyroid lesions. However, metastatic renal cell carcinoma to the thyroid gland also shows strong staining for DPP IV.

Bacterial contamination of dialysis solution can cause various complications; therefore, dialysis solution purification has been pursued. Particularly in the case of on-line hemodiafiltration (HDF), since the dialysis solution is directly injected into blood vessels, a further careful purification strategy is required. At our hospital, clinical laboratory technologists have also been working on purification management with clinical engineering technologists since the introduction of the bacterial endotoxin test. As a purification strategy, we evaluated the test introduced. As a result, we found that the collection tube used for the endotoxin test can also be used as a blood collection tube if we measure the endotoxin level early. As a count method for viable aerobic bacteria, we introduced a 37 mm quality monitor, which was easy to use and had a high detection rate. We are also active members of the Hemodialyzer Safety Management Committee, facilitating the improvement of purification management. The achievement rate for dialysis solution purification in the past 5 years was nearly 100% in reverse osmosis units and multipatient dialysate delivery equipment. We have experienced several instances of high viable bacterial counts at the site anterior to the endotoxin-retentive filter owing to unexpected equipment problems. The purification achievement rate at the coupler exit site was improved yearly and reached 100% in 2014. In on-line HDF equipment, 100% purification was achieved at all the sites that we examined. We have confirmed that on-line HDF can steadily provide a superpure dialysis solution; therefore, we introduced on-line HDF in 2015. Participation in purification management is important in team medical care and we want to contribute to dialysis solution purification in collaboration with the Nephrology Center.

Early identification of hearing impairment has been shown to improve prognosis; hence screening programs have been advocated. The neonatal hearing screening programs in Gunma Children’s Medical Center involve two-stage hearing screening tests. An automated auditory brainstem response (AABR) test using ALGO3i is first carried out followed by an auditory brainstem response (ABR) test using MEB9204 for further diagnostic evaluation. A retrospective study was conducted to examine the implementation status of newborn hearing screening of 461 infants in the neonatal intensive care unit (NICU) between January 2014 and December 2015. Among these infants, 411 underwent the AABR test, and 22 infants as referral cases underwent the ABR test. There were 50 infants in whom the ABR test was carried out without performing the AABR test. The sensitivity, specificity, and overall efficiency of the AABR were 89.7%, 86.7%, and 88.6%, respectively. Finally, the overall incidence of hearing impairment detected by our screening tests was 48 (10.4%) out of 461 in NICU. It was confirmed that hearing impairment was highly associated with NICU admission. The AABR referral values were 8.9% and 6.2% in the less than 1,000 g (extremely low birth weight: ELBW) group and the more than 2,500 g group, respectively. Our data showed that ELBW and normal birth weight in NICU admission are risk factors associated with hearing impairment.

Our hospital includes 207 beds for approximately 510 dialysis patients, and one clinical laboratory technician is exclusively assigned to work in the dialysis rooms. In 2011, our protocol for periodic blood biochemical tests was changed from 4 to 2 times per month, at which time, we attempted to expand the contents of medical tests and improve efficiency, including (1) performance of electrocardiogram examinations at the bedside in the dialysis room for all patients who need assistance, (2) performance of carotid artery echo examinations not only in the echo room but also at the bedside in the dialysis room, (3) regular checks of manipulation of self-monitoring of blood glucose (SMBG) levels by our diabetic patients, and (4) preparation of an examination guide for staff members of the dialysis room with related study sessions regularly conducted. By the end of 2015, electrocardiogram examinations were carried out efficiently, and carotid artery echo examinations were performed for nearly all cases, while SMBG guidance was enhanced and knowledge about examination procedures for the dialysis room staff members improved. Answers to a questionnaire survey conducted in 2016 confirmed that the assignment of a clinical laboratory technician to the dialysis room was meaningful, and the work performed by that technician and dialysis room staff members had become effectively streamlined.