Surveillance evaluation of the standardization of assay values for serum total 25-hydroxyvitamin D concentration in Japan.

Background To assess the vitamin D nutritional status, serum total 25-hydroxyvitamin D (25(OH)D) concentration is measured. We used six automated 25(OH)D immunoassays (AIAs) available in Japan and certified by the Vitamin D Standardization Program (VDSP) at the U.S. Center for Disease Control and Prevention to assess the concordance of the assay results. Methods Serum total 25(OH)D concentrations in SRM 972a and 20 serum samples from patients were determined using three liquid chromatography-tandem mass spectrometry (LC-MS/MS) and six AIAs (pilot study), and an additional 110 serum samples were assessed by the six AIAs (surveillance study). The assay bias from the results of LC-MS/MS by Chiba University or consensus values (i.e. average of six AIAs) was estimated using the procedure described in CLSI document EP09-A3. Results LC-MS/MS at Chiba University could completely separate 25(OH)D2, 25(OH)D3 and 3-epi-25(OH)D3, and the observed values including total 25(OH)D in SRM 972a were all within ±1·SD of the assigned values. All AIAs produced results greater than ±3·SD. In the pilot study, four of the six AIAs had an average percentage bias, as estimated by confidence interval (CI), larger than ±5% (acceptance criterion in CLSI); the bias converged from -6.5% to 3.2% after adjustment by LC-MS/MS. In the surveillance study, 25(OH)D concentrations in AIAs all adjusted to LC-MS/MS converged within ±5% from consensus values. However, some AIAs showed negative or positive bias from the consensus values. Conclusions Current AIAs in Japan continue to lack standardization. Manufacturers should implement quality assurance strategies so that their values more closely align to those of standard reference material 972a.

[Establishment of Healthy Japan 21 Regional plans according to local community type].

OBJECTIVE: To examine the establishment of Health Japan 21 regional plans according to the local community type. METHODS: We sent all the Japanese local governments a questionnaire regarding the establishment of health Japan 21 regional plans with a request to provide a hardcopy of established regional plans. RESULTS: Of the respondent 1954 local communities, the proportions regarding establishment of plans (including "Completed" and "In the course of") according to the community type were: major, middle sized cities and Tokyo metropolitan wards, 100%; other cities, 64.9%; towns, 40.7%; and villages, 38.8%. Of the 500 local communities which answered "Completed establishment", the proportions with release onto the internet (including "Completed" and "In the course of") were: major cities, 100%; middle sized cities, 67.7%; Tokyo metropolitan wards, 85.7%; other cities, 38.8%; towns, 13.5%; and villages, 14.3%. We examined whether each of the 462 collected regional plans included each of the national Health Japan 21's target themes and items, and found a tendency for smaller community' regional plans to be less likely to give comprehensive coverage. CONCLUSION: More support for smaller local governments is necessary to achieve establishment and effective implementation of Health Japan 21 regional plans.

Hypocretin-1 (orexin-A) levels in human lumbar CSF in different age groups: infants to elderly persons.

STUDY OBJECTIVES: Recent CSF and postmortem brain hypocretin measurements in human narcolepsy suggest that hypocretin deficiency is involved in the pathophysiology of the disease. In this study, we measured CSF hypocretin-1 levels in various age ranges from infants to elder people to investigate the age-dependent change of hypocretin concentrations. DESIGN: CSF hypocretin levels were compared by age groups and gender. ANOVA was used to examine the influences of these two parameters on CSF hypocretin levels. SETTING: University-based sleep and biology laboratory. PATIENTS OR PARTICIPANTS: Two hundred seventy two patients were included in this study, with 157 males and 115 females (0-79 years old). INTERVENTIONS: CSF samples were obtained by lumber punctures with informed consents. MEASUREMENTS AND RESULTS: Hypocretin-1 levels are not different in respect to gender or age, although our samples constitute a heterogeneous group with various disease conditions. CSF hypocretin-1 levels in infants under 4 months are similar to those in adults. CONCLUSIONS: Early maturation of hypocretin transmission is suggested. No age- or gender-dependent changes in CSF hypocretin is observed.

Immune complex transfer enzyme immunoassay for anti-ovalbumin IgA in serum.

BACKGROUND: An immune complex transfer enzyme immunoassay for antiovalbumin immunoglobulin A (IgA) was developed. METHODS: Serum-specific antibody was reacted simultaneously with 2,4-dinitrophenyl-bovine serum albumin-ovalbumin conjugate and ovalbumin-beta-D-galactosidase conjugate. The complex formed from the three components was trapped onto polystyrene balls coated with anti-2,4-dinitrophenyl group immunoglobulin G, eluted with epsilonN-2,4-dinitrophenyl-L-lysine and transferred to polystyrene balls coated with anti-human IgA alpha-chain. Bound beta-D-galactosidase activity was determined by fluorometry. RESULTS & CONCLUSIONS: The detection limit of this method for the measurement of specific anti-ovalbumin IgA was 9 fmol/tube, which was 20-fold lower than that of the enzyme-linked immunosorbent assay (ELISA). Because serum interference with this method was lower than that with the ELISA, the detection limit of this method was 300-fold lower than that by the ELISA. Anti-ovalbumin IgA was detected in 100% of healthy subjects, which was confirmed by pre-incubation with an excess amount of ovalbumin.

[Consciousness disturbance caused by iodoform absorption in a patient with decubitus ulcer topically treated with iodoform-gauze].

A 76-year-old man with supranuclear palsy, developed consciousness disturbance followed by the treatment of decubitus ulcer in the sacral region using iodoform-gauze. He was semicoma and tachycardia. His pupils were miotic and light reflexes were absent. EEG demonstrated diffuse and random slow activities. Plasma concentration of free iodine was high (151 micrograms/dl), but the other laboratory findings including thyroid functions were normal. He was diagnosed as suffering from iodoform poisoning. The symptoms and laboratory abnormalities of the patient recovered soon after the removal of iodoform-gauze. Although iodoform has been widely used for the treatment of wounds, there are few case reports of its side effects, such as consciousness disturbance, delirium, headache and tachycardia.

[Eczematous reactions after intravenous immunoglobulin therapy in two patients with Guillain-Barré syndrome and a patient with Miller Fisher syndrome].

The use of intravenous immunoglobulin (IVIG) has become an accepted treatment for patients with Guillain-Barré syndrome. Few patients develop adverse reactions to IVIG such as flushing, urticaria, eczema, chest tightness, wheezing, diaphoresis and hypotension. We report three patients who each received a five day course of IVIG at the standard dose of 0.4 g/kg/day. Two patients had Guillain-Barré syndrome, and the other had Miller Fisher syndrome. All developed eczematous reactions after 4 days from the start day of therapy to 5 days from the last day of therapy. One patient with GBS had widespread eczematous eruption with severe pompholyx lesions on the palms, fingers and soles, and spread over a period of 2 to 3 weeks to become generalized. That persisted for 4 weeks but gradually settled with desquamation by the use of topical steroids. None of our patients subsequently developed long-term or chronic eczema after the resolution of the initial cutaneous reaction. Eczematous reactions of our patients were similar to those reported in the literature and clinically typical as pompholyx. Although pompholyx has been recognized as a clinical entity, its cause remains obscure. Cutaneous reactions after IVIG infusion are recognized to be rare, but actually they may occur more frequently than our recognition, and its knowledge is essential to make the right clinical decision.

Commutability of National Institute of Standards and Technology standard reference material 1955 homocysteine and folate in frozen human serum for total folate with automated assays.

BACKGROUND: The aim of the present study was to evaluate standard reference material (SRM) 1955 commutability as a reference material for serum folate using automated methods. We also designed so as to reduce the intermethod variability present in different automated methods. METHODS: Using a microbiological assay related to the 'information value' of SRM 1955 as a comparison method, we investigated the possibility of standardization for the assay values of serum folate as measured by the automated methods (Access, Centaur and Elecsys). In the assay of 50 patient sera by these automated methods, we corrected observed values by the SRM 1955 and compared with comparison values. RESULTS: The observed values of SRM 1955 Levels I, II and III were within or outside (but near) a 95% prediction interval obtained from patient sera by the automated methods. The normalized residuals obtained from SRM 1955 were within ±3.0 (in SD units), which enabled us to conclude that the SRM 1955 had a physicochemical characterization similar to native serum. Twelve patients were assessed as hypofolataemia (<6.0 ng/mL) and 38 patients as normal (≥6.0 ng/mL). Before correction, folate levels in six of 12 patients were lower than 6.0 ng/mL, and those in seven of 38 patients were higher than 6.0 ng/mL with the automated methods. After correction, low levels were found in four of 12 patients, and normal levels were found in 33 of 38 patients. CONCLUSIONS: The use of SRM 1955 would help to reduce the intermethod variability present in different automated methods for serum folate measurement.

Hypocretin-1 (orexin-A) concentrations in cerebrospinal fluid are low in patients with Guillain-Barré syndrome.

It is reported that cerebrospinal fluid (CSF) hypocretin-1 (orexin-A) concentrations in patients with narcolepsy are significantly low. Human narcolepsy is also known to be closely associated with a specific human histocompatibility leukocyte antigen (HLA), suggesting that autoimmunity is involved in the pathophysiology of the disease. Thus, it is important to know whether hypocretin changes are found in definite neuroimmunological diseases such as multiple sclerosis and Guillain-Barré syndrome (GBS). The results of the present study indicate that some patients with GBS have lower levels of CSF hypocretin-1.