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ABSTRACT: The aim of this study was to compare the diagnostic and analytical performances of nine anti-cyclic citrullinated peptide (CCP) antibody assays. Anti-CCP antibody titers were measured in sera from 89 patients with rheumatoid arthritis (RA), 121 with rheumatic diseases other than RA (non-RA), 47 with osteoarthritis (OA), 142 with chronic inflammatory diseases (CID) and 168 healthy subjects. Reproducibility, sensitivity, specificity, correlation and concordance rate of the nine assays were compared. Coefficients of variations of within-run and between-run reproducibility at two different concentrations for each assay ranged from 0.7 to 8.5% and from 0.6 to 8.3%, respectively. With our proposed optimal cut-off value for the third-generation assay, concordance rates were 96.8~99.6%. The range of sensitivity was 75.3~78.7% and the ranges of specificity for non-RA, OA, CID, and healthy subjects were 93.4~97.5%, 97.9%, 96.5~98.6% and 98.8~100%, respectively. However, several discrepant samples were detected and their titer levels were about 3 times higher than the normal upper limit in the 2010 RA classification criteria. Good positive correlations were observed for parts of the second-generation assay. Our study showed that each of the nine assays has good reproducibility and high diagnostic accuracy, and is thus equally useful for the diagnosis of RA.
Japanese Journal of Clinical Immunology 01/2013; 36(2):104-14.
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Tetsushi Yamamoto,
Hidekazu Tanaka,
Kensuke Matsumoto,
Tomoko Lee,
Hiroyuki Awano,
Mariko Yagi,
Takamitsu Imanishi, Nobuhide Hayashi,
Yasuhiro Takeshima,
Hiroya Kawai,
Seiji Kawano,
Ken-Ichi Hirata
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ABSTRACT: Myocardial damage in Duchenne muscular dystrophy (DMD) has lethal outcomes, making early detection of myocardial changes in patients with DMD vital, because early treatment can help prevent the development of myocardial fibrosis. The aim of the present study was, therefore, to test the hypothesis that transmural strain profile (TMSP) analysis can predict future left ventricular (LV) dysfunction in patients with DMD with preserved ejection fraction. We studied 82 consecutive patients with DMD without LV wall motion abnormality, with an ejection fraction of 60 ± 5% (all ≥55%) and age 11 ± 3 years. Echocardiography was performed at baseline and 1 year of follow-up. TMSP in the posterior wall was evaluated from the mid-LV short-axis view. A normal TMSP pattern (1 peak in the endocardium, group 1) was seen in 44 patients, and TMSP with a notch (2 peaks in the endocardium, group 2) in the remaining 38 (46%). Wall motion abnormality in the posterior wall was observed in 16 patients (42%) in group 2 at 1 year of follow-up but in none of the patients in group 1 (42% vs 0%; p <0.001). Importantly, multivariate analysis showed that only TMSP with a notch (odds ratios 1.524, p <0.001) was an independent determinant of the presence of LV posterior wall motion abnormality at 1 year of follow-up. In conclusion, subclinical LV dysfunction can be detected by evaluation of TMSP in patients with DMD who do not have wall motion abnormalities by conventional echocardiography. TMSP with a notch proved effective for evaluating subtle early changes in patients with DMD and might be useful for predicting LV dysfunction.
The American journal of cardiology 12/2012; · 3.58 Impact Factor
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Tetsushi Yamamoto,
Tetsuari Onishi,
Alaa Marbrouk Salem Omar,
Kazuko Norisada,
Kazuhiro Tatsumi,
Kensuke Matsumoto, Nobuhide Hayashi,
Shouhiro Kinoshita,
Seiji Kawano,
Hiroya Kawai,
Ken-ichi Hirata,
Shunichi Kumagai
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ABSTRACT: We report the extremely rare case of a 73-year-old asymptomatic patient who has an isolated true parachute mitral valve (PMV).
In the echocardiographic examination, the parasternal long-axis view showed a single papillary muscle. The short-axis view
revealed the presence of a symmetric mitral valve orifice with all chordae attaching to a large anterolateral papillary muscle.
Because detailed examination did not reveal the presence of other complications, this patient was diagnosed as an isolated
true PMV.
KeywordsParachute mitral valve-Echocardiography-Asymptomatic-Isolated
Journal of Echocardiography 04/2012; 8(4):131-132.
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ABSTRACT: The aim of this study was to predict left ventricular (LV) dysfunction and the timing to perform echocardiography in patients with Duchenne muscular dystrophy (DMD). We developed a scoring system using clinical parameters and examined its efficacy. It is indispensable to utilize echocardiogram for evaluating myocardial damage of DMD patients, but there is no established guideline for determining the clinical conditions which require echocardiographic examination.
We retrospectively analyzed 86 patients with DMD who were treated in Kobe University Hospital from 2007 to 2009. The multiple logistic regression analysis on routine clinical data was performed to identify parameters that can find abnormal LV contraction, and to develop a weighted scoring system. Echocardiogram was performed as the gold standard for detecting LV dysfunction.
Four parameters were associated with abnormal LV contraction: (i) brain natriuretic peptide (BNP); (ii) creatine kinase; (iii) scoliosis; and (iv) body surface area. When BNP was used as the only predictor to evaluate LV systolic dysfunction, sensitivity and specificity were 36.4% and 92.1%, respectively. In contrast, abnormal LV contraction was detected in high accuracy (sensitivity: 95.5%; specificity: 68.3%) when we used a two-step scoring system in which BNP was combined with the other three factors, raising the sensitivity compared to using BNP levels as the single parameter (P= 0.008).
Our scoring system detects the early heart dysfunction of DMD patients, especially when BNP level is not elevated. This system is useful to determine the timing for echocardiographic examination and consulting cardiologists.
Pediatrics International 01/2012; 54(3):388-92. · 0.63 Impact Factor
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ABSTRACT: Anti-SS-A/Ro antibody is commonly found in the sera of patients with rheumatic disease. The antigenic components of SS-A/Ro are 60kD. and 52kD-Ro protein. Only anti-60kD SS-A/Ro antibody is detected by commonly used tests in clinical laboratories. "UniCAP EliA SS-A/Ro" is a new reagent using fluorescence enzyme immunoassay (FEIA) based on a mixture of both 60kD- and 52kD-Ro antigens. We evaluated the efficacy of detecting both anti-60kD and 52kD SS-A/Ro antibodies.
We collected sera from 264 rheumatic disease patients and 106 healthy subjects. Anti-SS-A/Ro antibodies were measured by the new reagent along with conventional method. Anti-52kD and 60kD SS-A/Ro antibodies were measured by ELISA kit in rheumatic disease patients.
Anti-SS-A/Ro antibody levels were higher in patients with Sjögren's syndrome than those with SLE or RA. The prevalence of anti-SS-A/Ro antibody in rheumatic disease patients and healthy subjects were comparable with the conventional method, and patients with Sjögren's syndrome had highest prevalence of anti-SS-A/Ro antibody. Concordance rate between EliA and conventional method, and EliA and DID, were 96.6% and 94.3%, respectively. ELISA analysis revealed that patients with Sjögren's syndrome had anti-52kD SS-A/Ro antibody at high rates, while anti-60kD SS-A/Ro antibody was widely found in rheumatic disease patients. Three patients were positive only for anti-52kD SS-A/Ro antibody.
Taken together, "UniCAP EliA SS-A/Ro" is useful as a screening test for anti-SS-A/Ro antibodies.
Rinsho byori. The Japanese journal of clinical pathology 04/2011; 59(4):352-9.
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Circulation 10/2010; 122(16):e488-90. · 14.74 Impact Factor
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Nippon rinsho. Japanese journal of clinical medicine 06/2010; 68 Suppl 6:502-5.
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ABSTRACT: Rheumatoid arthritis (RA) is a severe, progressive, systemic inflammatory disease of unknown etiology. Early diagnosis of RA is important to identify individuals who will develop severe destructive disease, so that effective treatment can be initiated before irreversible damage occurs. Rheumatoid factor (RF) has been commonly used as a serological marker for RA, although RF had a tolerable sensitivity of 75.9% for RA, but low specificity of 78.7% and 75.4% for patients with other rheumatic diseases and chronic inflammatory disease, respectively. Antibodies to citrullinated protein/peptide antigens, i.e., to peptides post-translationally modified by the conversion of arginine to cilrulline (ACPA), are specific serological markers for RA. Not only did anti-cyclic citrullinated peptide antibody (anti-CCP) demonstrate a higher sensitivity of 78.5% when compared to RF, but anti-CCP also had a much higher specificity of 95.9% and 97.9% for other rheumatic diseases and chronic inflammatory disease patients, respectively. Moreover, meta-analysis revealed that pooled sensitivity and pooled specificity were 67% and 95% for anti-CCP, 69% and 85% for RF, respectively, and that anti-CCP was more specific than RF for diagnosing RA. In 2009, ACPA (anti-CCP) was included in the new Criteria for RA from the American College of Rheumatology and the European League Against Rheumatism. Anti-CCP testing is particularly useful in the diagnosis of RA, being present early in the disease process, and able to predict severe disease and irreversible damage. In addition, the titers might be early predictors of the efficacy of anti-TNF therapy. In this review, we discuss the historical background of anti-CCP as well as its diagnostic performance, usefulness for early diagnosis, prognostic capability, and pathogenesis of RA.
Rinsho byori. The Japanese journal of clinical pathology 05/2010; 58(5):466-79.
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ABSTRACT: BioPlex2200 is a fully automated analyzer using multiplexed technology and BioPlex2200 ANA Screen can analyze 11 antinuclear antibodies (ANA). We evaluated simultaneous detection of 11 ANA and clinical utility as ANA screening test. We collected sera from 317 connective tissue disease (CTD) patients, 166 healthy subjects, and 105 sera in which anti dsDNA antibody(RIA) is requested. Detection of 11 ANA were measured by BioPlex2200 ANA Screen using BioPlex2200 along with conventional methods. We evaluated positive ratio for healthy subjects and CTD patients and concordance rate between BioPlex2200 and IF. The prevalence of disease specific ANA in CTD patients were comparable with general occurrence rate except anti dsDNA antibody (39.3%) in SLE. Concordance rate between BioPlex2200 and conventional methods were high(89.0-99.7%) except anti dsDNA antibody(ELISA: 68.8%, RIA: 58.1%). Discordant sera of Bioplex2200+/DID- for anti SS-A antibodies were observed in 30 sera, and 20 sera were positive only for anti 52kD SS-A/Ro antibody. As ANA screening test, positive ratio was low (7.2%) in healthy subjects, and comparable with that of IF(1:160). Concordance rate between BioPlex2200 and IF was low (75.1%). However, 44 sera of BioPlex2200+/IF- contained 6 samples positive for anti Jo-1 antibodies and 29 samples positive for anti-52kD SS-A/Ro antibodies. Diagnostic accuracy of the Medical Decision Support Software (MDSS) by BioPlex2200 as compared to clinical diagnosis is good for specificity. Taken together, BioPlex2200 can appropriately perform simultaneous detection of 11 ANA and detect independently anti-52kD SS-A/Ro antibody. However, detection for anti dsDNA antibody of low titers is needed to be improved.
Rinsho byori. The Japanese journal of clinical pathology 10/2009; 57(10):941-53.
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ABSTRACT: There exist inter-laboratory differences in measurements of rheumatoid factor (RF) and antinuclear antibodies (ANA), leading to a misdiagnosis of rheumatoid arthritis (RA) and other collagen diseases. This study was carried out to bring the positivity of RF and ANA of different reagents into accord by standardizing their data. The titer and cutoff value was inconsistent among the 17 different kits. We found a possibility in standardization of RF by a new concept in cooperation with Japanese Committee for Clinical Laboratory Standards (JCCLS). Sera from 1300 healthy subjects and 79 RA patients were measured for RF by 17 different RF kits, and sera with a little deviation among the kits were selected. Panels for detection of RF positive rate in healthy subjects were made from the pooled sera. The cutoff value in 5% positive in the panel was defined tentatively as 15 IU/ml. The 100 IU/ml was also able to become in general accord by adjusting the individual data using pooled RF-positive reference sera. The nationwide survey of immunofluorescence ANA (IF-ANA) was performed in 41 laboratories using 6 pooled sera. The reported titer was fairly different among laboratories, and a striking discrepancy was found for low-titer samples. When the titer was corrected by simultaneously measured reference serum, inconsistency of ANA titer among different laboratories was mostly compensated. Here, we propose a new method for standardization of RF and also try to standardize the positivity of RF and IF-ANA by providing pooled reference sera.
Rinsho byori. The Japanese journal of clinical pathology 02/2009; 57(1):31-41.
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ABSTRACT: Estimation of Glomerular filtration rate (GFR) is crucial for the detection of renal insufficiency. In clinical practice, GFR is generally estimated from Ccr by some prediction formulas including the serum creatinine concentration and some variables: age, sex, body size. It has been suggested that serum cystatin C is less influenced by sex, body size, muscular mass or inflammation. In several studies, serum cystatin C performed better than serum creatinine did as a marker to detect GFR reduction. We developed the formula for predicting creatinine clearance (Ccr) from serum cystatin C, serum creatinine and serum beta 2-microgroburin by multiple regression analysis. In this study, we analysed 24-hour Ccr and variables (sex, age and BMI) in 82 subjects with renal diseases to develop suitable formulas. Our serum cystatin C formula is as follows: Ccr (ml/min/1.73m2) = (12.14-0.03 x age-1.72 x serum cystatin C) 2. Correlation between measured 24-hour Ccr and predicted Ccr by our serum cystatin C formula was higher (r=0.852) than our serum creatinine formula (r=0.755), serum beta 2-microgroburin formula (r=0.793), Cockcroft-Gault formula (r=0.836) and Horio formula (r=0.825). Accuracy within 15% was higher (39.0%) than other formulas (25.6-30.5%). Our formula using serum cystatin C for predicting Ccr is a useful and precise marker for Ccr than other commonly used formulas using serum creatinine.
Rinsho byori. The Japanese journal of clinical pathology 01/2009; 56(12):1093-9.
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Nobuhide Hayashi
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ABSTRACT: The Department of Medical Technology Support was inaugurated at Kobe University Hospital in 2008, and various paramedical staff members were evaluated positively by one of the departments of the same unit at the hospital. According to this evaluation, they have not only performed their routine work efficiently, but have also been able to contribute through novel research activities. Since 1995, eight technicians in the Department of Clinical Laboratory including myself have been able to carry out research under our supervisor, Prof. Shunichi Kumagai, and, up to the present, four individuals have written a doctoral dissertation and each has obtained a PhD. Naturally, clinical research consists of employing novel analyses and techniques, and medical technologists are able to apply their abilities directly in this respect. When medical technologists are not experts in new techniques, they should plan to acquire such knowledge and practice these techniques. Through identifying new research problems in their routine work and carrying out collaborative clinical research, not only do they witness an advance in their own academic level, but they are reassured that they are able to contribute significantly to clinical fields. Thus, medical technologists must tackle research proactively.
Rinsho byori. The Japanese journal of clinical pathology 11/2008; 56(10):900-5.
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ABSTRACT: Rheumatoid factor (RF) has been commonly used as a biomarker of rheumatoid arthritis (RA). It is important to diagnose RA early and to prevent joint destruction before irreversible damage occurs. For this purpose, several new biomarkers, such as anti-cyclic citrullinated peptide antibody (anti-CCP) and matrix metalloproteinase-3 (MMP-3), have become available for both the diagnosis and prognosis of RA. RF showed a tolerable sensitivity of 68.5% for RA, but low specificity of 77.1% for patients with other rheumatic diseases. Anti-agalactosyl IgG antibodies (CARF) showed a slightly higher sensitivity of 73.9%, but specificity as low as that for RF. In contrast, anti-CCP demonstrated high sensitivity of 76.1% and marked specificity of 92.4% for patients with other rheumatic diseases. Anti-CCP was significantly superior to other biomarkers on receiver-operating characteristic curve (ROC) analysis. Moreover, meta-analysis revealed that the pooled sensitivity and specificity were 67% and 95% for anti-CCP, and 69% and 85% for RF, respectively, and that anti-CCP was more specific than RF for diagnosing RA. On the other hand, MMP-3 has been suggested to be a prognostic biomarker as well as an evaluative biomarker for RA. We next examined if the diagnostic accuracy of early RA is improved by combining these biomarkers. The specificity of RF was not as high as anti-CCP but rose to 92% when combined with MMP-3. Thus, we concluded that anti-CCP is superior to other biomarkers in terms of diagnostic accuracy, and that these combined assays are useful in the early diagnosis of RA.
Rinsho byori. The Japanese journal of clinical pathology 05/2008; 56(4):297-308.
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ABSTRACT: The aim of this study was to investigate the types and prevalence of disease-specific antinuclear antibodies (ANAs) and their relationship to rheumatic diseases in the general Japanese population. An immunofluorescence (IF) method was used for the first screening of ANA levels in serum samples obtained from 2181 residents of a small Japanese town. Individuals positive for IF-ANA were then further tested for disease-specific ANAs using eight enzyme immunoassays. Physical status and the presence of illness were determined by means of questionnaires and medical examinations. Based on the result of the IF-ANA assay, the rates of positive samples at 1:40 and 1:160 dilutions were 26.0 and 9.5%, respectively, with females have significantly higher positivity rates than males (P < 0.0001). Among 566 IF-ANA-positive individuals, 100 individuals were found to have 114 disease-specific ANAs. Anti-SSA/Ro, anti-centromere, and anti-U1RNP antibodies were detected in 58, 30, and 11 individuals, respectively, but anti-Sm, anti-Scl-70, and anti-Jo-1 antibodies were undetectable. Questionnaires and medical examinations revealed that among 60 disease-specific ANA-positive individuals that were available for testing, six had Sjögren's syndrome (SS), five were suspected of having SS, and five had rheumatoid arthritis. Surprisingly, 34 (57%) of the disease-specific ANA-positive individuals were clinically healthy. Anti-SSA/Ro, anti-centromere, and anti-U1RNP antibodies were quite frequent among clinically healthy Japanese subjects, although anti-Sm, anti-Scl-70, and anti-Jo-1 antibodies were not. Of the 60 individuals who tested positive for disease-specific ANAs, 30% (18/60) actually manifested systemic rheumatic diseases, while 50% showed no detectable signs or symptoms of rheumatic diseases.
Modern Rheumatology 02/2008; 18(2):153-60. · 1.58 Impact Factor
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ABSTRACT: To prevent joint destruction, it is important to diagnose RA early and to consider the prognosis. For this purpose, several new laboratory tests, such as IgG-RF, anti-agalactosyl IgG antibodies (CARF), and matrix metalloproteinase-3 (MMP-3), have become available for diagnosing RA. RF has a tolerable sensitivity of 68.5% for RA, but low specificity of 77.1%, and also 76.0% for patients with other rheumatic diseases and chronic inflammatory disease, respectively. CARF showed slightly higher sensitivity but low specificity for other rheumatic diseases and chronic inflammatory patients. In contrast, anti-cyclic citrullinated peptide antibody (anti-CCP), a new diagnostic test for RA, demonstrated significantly high specificity for other rheumatic diseases, and also for chronic inflammatory disease patients. Anti-CCP was superior to other laboratory tests by ROC analysis. Moreover, both CARF and anti-CCP had higher sensitivity of 66.7%, 61.5%, respectively, for the diagnosis of early RA than RF. On the other hand, MMP-3 is thought to be not only an evaluative test for the activity of RA because of its significant correlation with CRP, but also has potential as a prognostic test to identify joint damage from RA. Anti-CCP was also reported to associate with the progression of joint damage and may be also used as a prognostic test. We next examined the efficiency of RA diagnosis made by combining these laboratory tests. The specificity of RF was not as high as anti-CCP but reached 92% when combined with MMP-3. Thus, it is concluded that anti-CCP is superior to other laboratory tests in sensitivity and specificity, and that these combination assays are useful in the early diagnosis of RA.
Rinsho byori. The Japanese journal of clinical pathology 05/2007; 55(4):388-96.
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Modern Rheumatology 02/2007; 17(5):447-9. · 1.58 Impact Factor
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ABSTRACT: 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.
Rinsho byori. The Japanese journal of clinical pathology 01/2007; 54(12):1204-8.
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ABSTRACT: 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.
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.
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.
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.
Clinical Chemistry 07/2006; 52(7):1423-6. · 7.91 Impact Factor
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Tsutomu Nakamura,
Takeshi Ioroi,
Toshiyuki Sakaeda,
Masanori Horinouchi, Nobuhide Hayashi,
Kensuke Saito,
Mitsuro Kosaka,
Noboru Okamura,
Keiichi Kadoyama,
Shunichi Kumagai,
Katsuhiko Okumura
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ABSTRACT: Cystatin C (Cys-C) has been recently paid great attention as a better endogenous marker of the glomerular filtration rate than creatinine (Cr). In this study, the usefulness of Cys-C was compared with Cr in terms of the estimation of the steady-state serum trough concentrations of digoxin in Japanese patients. Forty patients treated with digoxin and 56 healthy elderly subjects were participated in this study. The serum levels of Cys-C and Cr in the patients were higher than those in the healthy elderly subjects, but the increase of Cys-C was more predominant in the patients. Their levels were well-correlated for both of the healthy elderly subjects (r=0.691) and patients (r=0.774), but the serum concentrations of digoxin were better correlated with those of the reciprocal values of Cr (r=0.667) than those of Cys-C (r=0.383), presumably due to the fact that digoxin and Cr were excreted via both glomerular filtration and tubular secretion. Cys-C is useful for the substratification of the patients diagnosed to have normal renal function with Cr of < 1.3 mg/dL into those with normal and pseudo-normal renal function, resulting in the corresponding serum concentrations of digoxin.
International journal of medical sciences 01/2006; 3(3):92-6. · 2.24 Impact Factor
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Nippon rinsho. Japanese journal of clinical medicine 08/2005; 63 Suppl 7:456-9.
