Performance evaluation of a direct chemiluminescence assay for 25-hydroxyvitamin D and its application in assessing vitamin D status among reproductive-age women in southeastern China
4 affiliations
- 1Department of Laboratory Medicine, Fujian Key Clinical Specialty of Laboratory Medicine, Women and Children’s Hospital, School of Medicine, Xiamen University, Xiamen, China
- 2Medical Laboratory of Xiamen Humanity Hospital Fujian Medical University, Xiamen, China
- 3Xiamen Innodx Biotech Co., Ltd, Xiamen, China
- 4Department of Health Management, Women and Children’s Hospital, School of Medicine, Xiamen University, Xiamen, China
Abstract
Background: Vitamin D deficiency is a global public health concern, and women of reproductive age represent a particularly vulnerable population. Accurate measurement of serum 25-hydroxyvitamin D [25(OH)D] is therefore essential for reliable clinical assessment. This study aimed to evaluate the analytical performance of the Innodx vitamin D assay for 25(OH)D measurement and to investigate the prevalence of vitamin D deficiency among women of reproductive age in southeastern China. Methods: This cross-sectional study enrolled women of reproductive age (20–45 years) who sought medical services at Xiamen Maternal and Child Health Hospital in China between November 2023 and September 2025. Serum 25(OH)D levels were measured to determine vitamin D status using the Innodx vitamin D assay (Xiamen Innodx Biotech Co., Ltd., Xiamen, China). The analytical performance of the assay was validated according to Clinical and Laboratory Standards Institute (CLSI) guidelines, covering precision, accuracy, linearity, and interference. A method comparison was performed against liquid chromatography-tandem mass spectrometry (LC-MS/MS) and the Roche electrochemiluminescence assay. Based on the measured levels, vitamin D status was categorized as deficient (< 20 ng/mL), insufficient (≥20, < 30 ng/mL), or sufficient (≥ 30 ng/mL). Results: The intra-assay coefficients of variation (CV) were 3.18%, 2.09%, and 1.86% at three concentration levels (5, 25, and 100 ng/mL), while intermediate precision CVs were 4.34%, 3.64%, and 3.17%, respectively. Accuracy testing showed bias of 4.20% and 3.26% at 20 and 50 ng/mL. The assay demonstrated excellent linearity (R2 = 0.998) across the range of 4.0-150.0 ng/mL. No significant interference was observed from hemoglobin (100 mg/dL), bilirubin (40 mg/dL), triglycerides (400 mg/dL), or rheumatoid factor (600 IU/mL). In method comparison with LC-MS/MS, the Innodx vitamin D assay demonstrated strong concordance with a Pearson correlation coefficient of r = 0.970. When compared with the Roche vitamin D assay, the Innodx showed better correlation with LC-MS/MS. Among 495 women, the mean 25(OH)D concentration was 20.50 ± 7.88 ng/mL, with 88.9% (95% CI: 86.1%, 91.7%) having vitamin D deficiency or insufficiency. Women aged ≤ 25 years showed significantly lower levels (18.38 ± 6.26 ng/mL) compared to older groups (31–35 years: 23.31 ± 8.97 ng/mL; > 35 years: 23.72 ± 8.56 ng/mL) (P < 0.05). Conclusion: The Innodx vitamin D chemiluminescence assay demonstrated satisfactory analytical performance for clinical use. Our findings reveal a high prevalence of vitamin D deficiency among reproductive-age women in southeastern China, particularly in younger age groups, highlighting the need for public health interventions.
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BibTeX
@article{zhu2026performance,
title = {{Performance evaluation of a direct chemiluminescence assay for 25-hydroxyvitamin D and its application in assessing vitamin D status among reproductive-age women in southeastern China}},
author = {Min Zhu and Tianhua Chen and Jiali Cao and Linhua Luo and Minchuan Lin and Haiying Huang and Weiwei Xu and Lihua Li and Hongbin Xie and Xiaoli Chen and Huiming Ye},
journal = {PLOS One},
year = {2026},
month = sep,
doi = {10.1371/journal.pone.0356809},
url = {https://doi.org/10.1371/journal.pone.0356809},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Performance evaluation of a direct chemiluminescence assay for 25-hydroxyvitamin D and its application in assessing vitamin D status among reproductive-age women in southeastern China
AU - Min Zhu
AU - Tianhua Chen
AU - Jiali Cao
AU - Linhua Luo
AU - Minchuan Lin
AU - Haiying Huang
AU - Weiwei Xu
AU - Lihua Li
AU - Hongbin Xie
AU - Xiaoli Chen
AU - Huiming Ye
PY - 2026
DA - 2026/09/15
JO - PLOS One
DO - 10.1371/journal.pone.0356809
UR - https://doi.org/10.1371/journal.pone.0356809
AB - Background: Vitamin D deficiency is a global public health concern, and women of reproductive age represent a particularly vulnerable population. Accurate measurement of serum 25-hydroxyvitamin D [25(OH)D] is therefore essential for reliable clinical assessment. This study aimed to evaluate the analytical performance of the Innodx vitamin D assay for 25(OH)D measurement and to investigate the prevalence of vitamin D deficiency among women of reproductive age in southeastern China. Methods: This cross-sectional study enrolled women of reproductive age (20–45 years) who sought medical services at Xiamen Maternal and Child Health Hospital in China between November 2023 and September 2025. Serum 25(OH)D levels were measured to determine vitamin D status using the Innodx vitamin D assay (Xiamen Innodx Biotech Co., Ltd., Xiamen, China). The analytical performance of the assay was validated according to Clinical and Laboratory Standards Institute (CLSI) guidelines, covering precision, accuracy, linearity, and interference. A method comparison was performed against liquid chromatography-tandem mass spectrometry (LC-MS/MS) and the Roche electrochemiluminescence assay. Based on the measured levels, vitamin D status was categorized as deficient (< 20 ng/mL), insufficient (≥20, < 30 ng/mL), or sufficient (≥ 30 ng/mL). Results: The intra-assay coefficients of variation (CV) were 3.18%, 2.09%, and 1.86% at three concentration levels (5, 25, and 100 ng/mL), while intermediate precision CVs were 4.34%, 3.64%, and 3.17%, respectively. Accuracy testing showed bias of 4.20% and 3.26% at 20 and 50 ng/mL. The assay demonstrated excellent linearity (R2 = 0.998) across the range of 4.0-150.0 ng/mL. No significant interference was observed from hemoglobin (100 mg/dL), bilirubin (40 mg/dL), triglycerides (400 mg/dL), or rheumatoid factor (600 IU/mL). In method comparison with LC-MS/MS, the Innodx vitamin D assay demonstrated strong concordance with a Pearson correlation coefficient of r = 0.970. When compared with the Roche vitamin D assay, the Innodx showed better correlation with LC-MS/MS. Among 495 women, the mean 25(OH)D concentration was 20.50 ± 7.88 ng/mL, with 88.9% (95% CI: 86.1%, 91.7%) having vitamin D deficiency or insufficiency. Women aged ≤ 25 years showed significantly lower levels (18.38 ± 6.26 ng/mL) compared to older groups (31–35 years: 23.31 ± 8.97 ng/mL; > 35 years: 23.72 ± 8.56 ng/mL) (P < 0.05). Conclusion: The Innodx vitamin D chemiluminescence assay demonstrated satisfactory analytical performance for clinical use. Our findings reveal a high prevalence of vitamin D deficiency among reproductive-age women in southeastern China, particularly in younger age groups, highlighting the need for public health interventions.
SN - 1932-6203
ER -