Collaborative derivation of reference intervals for major clinical laboratory tests in Japan

Ichihara, Kiyoshi; Yomamoto, Yoshikazu; Hotta, Taeko; Hosogaya, Shigemi; Miyachi, Hayato; Itoh, Yoshio; Ishibashi, Midori; Kang, Dongchon

doi:10.1177/0004563215608875

Cited by 50 publications

(45 citation statements)

References 14 publications

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“…The Japan Society of Clinical Chemistry established common RIs for use nationwide in Japan for 40 commonly tested laboratory tests [14]. Annual external quality controls have been done for the major analytes among the affiliated medical facilities in the northern region of Kyushu Island[15], and we confirmed the standardized status of all the assays[16].…”

Section: Methodssupporting

confidence: 59%

“…In order to exclude inappropriate infants with multiple abnormal results, a multivariate iterative method called latent abnormal values exclusion (LAVE) [14] [15] [16] was applied for simultaneous derivation of RIs for multiple test items. In this study, the LAVE method was used for the values of WBC, HGB, HCT, TP, BUN, CK, K, LDH, ALT, and CRP with eight iterations and an allowance of up to one result outside the RI and up to one missing result in the reference test items.…”

Section: Methodsmentioning

confidence: 99%

“…The parametric method was used for computing the RIs after transforming the distribution of the reference values into a Gaussian form using a modified Box-Cox transformation [14]. The 90% confidence intervals (CIs) for the upper (UL) and lower limits (LL) of the RIs were estimated by the bootstrap method to avoid any abnormal results in the reference test [17, 18].…”

Section: Methodsmentioning

confidence: 99%

“…The 90% confidence intervals (CIs) for the upper (UL) and lower limits (LL) of the RIs were estimated by the bootstrap method to avoid any abnormal results in the reference test [17, 18]. The need to partition the reference values by sex, GA, and BW was judged based on the SD ratio (SDR) introduced by Ichihara [14]; the SDR for sex (SDR SEX ) is expressed as the SD representing the sex difference divided by the SD of the RI (SD RI , or 1/4th of RI). Similarly, the SDRs for GA and BW (SDR GA , SDR BW ) were computed as a ratio of the SD representing the between-GA and between-BW subgroup differences divided by the SD RI , respectively.…”

Section: Methodsmentioning

confidence: 99%

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Blood Reference Intervals for Preterm Low-Birth-Weight Infants: A Multicenter Cohort Study in Japan

et al. 2016

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Preterm low-birth-weight infants remain difficult to manage based on adequate laboratory tests. The aim of this study was to establish blood reference intervals (RIs) in those newborns who were admitted to and survived in the neonatal intensive care unit (NICU). A multicenter prospective study was conducted among all infants admitted to 11 affiliated NICUs from 2010 to 2013. The clinical information and laboratory data were registered in a network database designed for this study. The RIs for 26 items were derived using the parametric method after applying the latent abnormal values exclusion method. The influence of birth weight (BW) and gestational age (GA) on the test results was expressed in terms of the standard deviation ratio (SDR), as SDRBW and SDRGA, respectively. A total of 3189 infants were admitted during the study period; 246 were excluded due to a lack of blood sampling data, and 234 were excluded for chromosomal abnormalities (n = 108), congenital anomalies requiring treatment with surgical procedures (n = 76), and death or transfer to another hospital (n = 50). As a result, 2709 infants were enrolled in this study. Both the SDRGA and SDRBW were above 0.4 in the test results for total protein (TP), albumin (ALB), alanine aminotransferase (ALT), and red blood cells (RBC); their values increased in proportion to the BW and GA. We derived 26 blood RIs for infants who were admitted to NICUs. These RIs should help in the performance of proper clinical assessments and research in the field of perinatal-neonatal medicine.

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Section: Methodssupporting

confidence: 59%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Blood Reference Intervals for Preterm Low-Birth-Weight Infants: A Multicenter Cohort Study in Japan

et al. 2016

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“…The recovery of polyclonal Ig was defined as normalization of values of serum IgG, IgA, and IgM by routine laboratory examination 1 year after ASCT. The normal range used in our hospitals is based on the reference intervals proposed by the Japanese Committee for Clinical Laboratory Standards and is as follows: IgG, 861-1747 mg/dL; IgA, 93-393 mg/dL; and IgM, 33-183 mg/dL for male, 50-269 mg/dL for female [41]. Treatment response was assessed according to the uniform response criteria by the IMWG [42].…”

Section: Patients and Treatmentmentioning

confidence: 99%

Polyclonal Immunoglobulin Recovery after Autologous Stem Cell Transplantation Is an Independent Prognostic Factor for Survival Outcome in Patients with Multiple Myeloma

Ozaki

Harada

Yagi

et al. 2019

Cancers

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We retrospectively analyzed multiple myeloma (MM) patients who underwent autologous stem cell transplantation (ASCT) without maintenance therapy to assess the impact of recovery of normal immunoglobulin (Ig) on clinical outcomes. The recovery of polyclonal Ig was defined as normalization of all values of serum IgG, IgA, and IgM 1 year after ASCT. Among 50 patients, 26 patients showed polyclonal Ig recovery; 14 patients were in ≥complete response (CR) and 12 remained in non-CR after ASCT. The patients with Ig recovery exhibited a significantly better progression-free survival (PFS, median, 46.8 vs. 26.7 months, p = 0.0071) and overall survival (OS, median, not reached vs. 65.3 months, p < 0.00001) compared with those without Ig recovery. The survival benefits of Ig recovery were similarly observed in ≥CR patients (median OS, not reached vs. 80.5 months, p = 0.061) and non-CR patients (median OS, not reached vs. 53.2 months, p = 0.00016). Multivariate analysis revealed that non-CR and not all Ig recovery were independent prognostic factors for PFS (HR, 4.284, 95%CI (1.868–9.826), p = 0.00059; and HR, 2.804, 95%CI (1.334–5.896), p = 0.0065, respectively) and also for OS (HR, 8.245, 95%CI (1.528–44.47), p = 0.014; and HR, 36.55, 95%CI (3.942–338.8), p = 0.0015, respectively). Therefore, in addition to the depth of response, the recovery of polyclonal Ig after ASCT is a useful indicator especially for long-term outcome and might be considered to prevent overtreatment with maintenance therapy in transplanted patients with MM.

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Comparative evaluation of methods to determine intra‐individual reference ranges in nutrition support team (NST)‐related tests

Hirabayashi

Tsutsumi²,

Sakurai

et al. 2020

Clinical Laboratory Analysis

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Background The intra‐individual reference range is generally narrower than the commonly used reference range. Consequently, close monitoring of changes in the laboratory test results of individuals based on the inter‐individual reference range remains challenging. Methods We examined the determination of individual reference ranges using four indicators of nutritional conditions: transferrin (TRF), albumin (ALB), retinol‐binding protein (RBP), and transthyretin (TTR). The subjects comprised 20 healthy individuals and blood samples were collected and tested five times at 2‐week intervals. We used the measurement results for the four indicators and examined individual reference ranges using four methods, including calculation methods based on the reference change value and Bayesian inference. Results The resulting intra‐individual reference ranges were narrower than the currently used inter‐individual reference range for all measurements using four methods. Furthermore, the intra‐individual coefficient of variation [CV (intra)] was smaller than the inter‐individual coefficient of variation [CV (inter)] for TRF, RBP, and TTR for all 20 subjects. The means CV (intra) for the four indicators were also lower than the corresponding CV (inter). Conclusions The intra‐individual reference range can be used to validate the standard deviation and coefficient of variation for currently used indicators. Moreover, Bayesian methods are speculated to be the most versatile.

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Collaborative derivation of reference intervals for major clinical laboratory tests in Japan

Cited by 50 publications

References 14 publications

Blood Reference Intervals for Preterm Low-Birth-Weight Infants: A Multicenter Cohort Study in Japan

Blood Reference Intervals for Preterm Low-Birth-Weight Infants: A Multicenter Cohort Study in Japan

Polyclonal Immunoglobulin Recovery after Autologous Stem Cell Transplantation Is an Independent Prognostic Factor for Survival Outcome in Patients with Multiple Myeloma

Comparative evaluation of methods to determine intra‐individual reference ranges in nutrition support team (NST)‐related tests

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