Double Antibody Sandwich Method Facilitates Accurate Vitamin D TestingMindray's New Generation Vitamin D Kits Now Available
2025-01-22
Applications
Vitamin D plays an important role in maintaining calcium and phosphorus homeostasis. Vitamin D deficiency may lead to skeletal problems such as rickets, osteomalacia, progressive bone loss, and osteoporosis [1]. It may also lead to cancer, autoimmune diseases, and cardiovascular diseases [2]. Thus, it is of great significance to assess the nutritional status of vitamin D in the human body on time and achieve individualized vitamin D supplementation.
According to the American Endocrine Society's clinical practice guidelines?[3], "vitamin D insuffciency" is defined as 25-OH Vitamin D <30 ng/mL.
| Vitamin D Status | 25-OH Vitamin D Concentration Range |
|---|---|
| Deficiency | < 20 ng/mL (<50 nmol/L) |
| Insufficiency | 20-30 ng/mL (50-75 nmol/L) |
| Sufficiency | > 30 ng/mL (75 nmol/L) |
| Toxicity | > 150 ng/mL (375 nmol/L) |
Currently, vitamin D insufficiency and deficiency are common problems worldwide. According to the study, over 60% of people are deficient in vitamin D worldwide [4]. Pregnant women, infants, children, the elderly, and obese people are especially at high risk of vitamin D deficiency.
Mindray VD-T II Product Features
Mindray VD-T II reagents are traceable to the ID-LC/MS/MS reference method calibrated by SRM 2972, ensuring accurate results while providing a basis for comparability of measurements between systems.
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Mindray's VD-T II reagent has passed the CDC VDSCP certification and participated in the DEQAS certification with excellent results.
The two-site sandwich detection method improves the sensitivity and precision of the reagent; the test results are highly consistent with the mass spectrometry method.
Excellent performance of Mindray VD-T II
| Sample | Mean | Within-run precision CV (%) | Within-laboratory precision CV (%) | |
|---|---|---|---|---|
| ng/mL | nmol/L | |||
| QC-L | 6.80 | 17.00 | 1.80% | 3.72% |
| QC-H | 46.55 | 116.38 | 1.78% | 3.19% |
| Human serum 1 | 13.80 | 34.50 | 2.29% | 3.71% |
| Human serum 2 | 31.97 | 79.93 | 2.38% | 5.82% |
Long-term quality control
| Sample | Target Value (ng/mL) | Measured Value (ng/mL) | Related Deviation |
|---|---|---|---|
| serum 1 | 15.48 | 15.23 | -1.61% |
| serum 2 | 40.78 | 40.85 | 0.18% |
Accurate detection of Vitamin D levels is essential for diagnosing and monitoring diseases related to skeletal problems. Mindray is dedicated to meeting clinical needs by seamlessly integrating every facet of our value chain, from raw material design to reagent production. This approach allows us to develop diagnostic assays ideally suited for clinical settings.
References
[1] Passeri G, et al. ow vitamin D status, high bone turnover, and bone fractures in centenarians. J Clin Endocrinol Metab 2003:88:5109-5115.
[2] Souberbielle JC et al. Vitamin D and musculoskeletal health, cardiovascular disease, autoimmunity and cancer: Recommendations for clinical practice.Autoimmunity Reviews 2010; 9: 709-715.
[3] Michael f. Holick, Neil c. Binkley, Heike A. Bischoff-Ferrari, Catherine M. Gordon, David A. Hanley, Robert P.Heaney, M. Hassan Murad, Connie M. Weaver, Evaluation, Treatment, and Prevention of Vitamin D Deficiency: an Endocrine Society Clinical Practice Guideline, The Journal of Clinical Endocrinology & Metabolism, Volume 96, lssue7,1 July 2011, Pages 1911-1930
[4] Martin,Rosas-Peralta,Michael,et al.Dysfunctional immunometabolic effects of vitamin D deficiency, increased cardiometabolic risk, Potential epidemiological alert in America?!l.Endocrinologia Diabetes y Nutrición.2017.DOl:10.1016/i.endien.2017.04.006.
