Getein Advanced Sandwich Assay Delivers Mass Spectrometry-level Accuracy for 25-OH-VD Test Results

25-OH-VD Testing Market Overview

From 2024 to 2029, the global Vitamin D testing market is expected to experience accelerated growth.

According to market research reports, the global Vitamin D testing market reached approximately USD 0.91 billion in 2023. By 2029, the global market size is projected to grow to around USD 1.57 billion.

Key growth drivers include:

• Increasing public health awareness
• High prevalence of Vitamin D deficiency-related diseases
• Continuous growth of the aging population

Prevalence of Vitamin D Deficiency

Vitamin D deficiency has become a global public health concern, driven by modern lifestyles, reduced outdoor activity, and limited sun exposure.

International clinical consensus and studies indicate that Vitamin D insufficiency is highly prevalent across diverse populations worldwide.

Main causes include:

• Insufficient sunlight exposure
• Inadequate dietary intake

Currently, there is no globally unified standard for assessing Vitamin D nutritional status. In China, the following classification is widely accepted:

Serum 25-OH-VD Levels:

• <20 ng/mL (50 nmol/L): Deficiency
• 20–30 ng/mL (50–75 nmol/L): Insufficiency
• >30 ng/mL (>75 nmol/L): Sufficiency

Multi-center studies in China show:

• Deficiency prevalence: 61.3%
• Insufficiency prevalence: up to 91.2%

Clinical Value & Challenges

Vitamin D testing is a fundamental assay in:

• Maternal and child health
• Bone metabolism management
• Chronic disease prevention

However, clinical practice still faces three major challenges:

• Can domestic reagents match the accuracy of mass spectrometry (LC-MS/MS) and imported products?
• Are results consistent across different sample types (venous blood vs. capillary blood)?
• How to ensure both sensitivity and efficiency in routine testing?

New Generation 25-OH-VD Assay by Getein Biotech

Mass Spectrometry-Level Accuracy

• Reference method aligned with LC-MS/MS
• Traceable to NIST SRM 972 standard material

Higher Sensitivity

• Dual-antibody sandwich design with enhanced signal amplification
• LOD as low as 1.0 ng/mL — no more missed low-value samples

Wider Linear Range

• Expanded upper and lower detection limits
• Minimizes dilution and repeat testing

Stronger Anti-Interference Capability

• Day-to-day precision CV <5%
• Stable performance across runs, ensuring reliable data and low retest rates

Efficient & Convenient

• Results available in 8 minutes (POCT)
• Requires only 10-20 μL sample volume (S/P/WB/Peripheral Blood)
• Suitable for capillary blood and emergency/POCT scenarios

Standardized Quality Assurance

• Continuously passes National Center for Clinical Laboratories (NCCL) external quality assessment programs

Four Sample Types, One Calibration Curve

• Serum, plasma, whole blood, and capillary blood share a unified calibration system
• Clinical validation shows bias <5%
• Interchangeable sample types with consistent results and simplified workflow

New Clinical Validation Data

The Getein 25-OH-VD (Sandwich Assay) has been validated through comparative studies against LC-MS/MS and a leading international brand reagent.

Results demonstrate high consistency and strong correlation, confirming its clinical reliability and accuracy.

Getein's Solutions for 25-OH-VD

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