WS/T 478-2024 in English
VALIDDetermination of serum 25-hydroxyvitamin D2 and D3 by isotope dilution liquid chromatography tandem mass spectrometry
- Issued on:2024-05-09
- Implemented on:2024-11-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$242.00
| Standard No: | WS/T 478-2024 |
| Document status: | VALID |
| Title in English: | Determination of serum 25-hydroxyvitamin D2 and D3 by isotope dilution liquid chromatography tandem mass spectrometry |
| Title in Chinese: | 血清25-羟基维生素D2和D3检测 同位素稀释液相色谱串联质谱法 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2024-05-09 |
| Implemented on: | 2024-11-01 |
| ICS Classification: | 11.020-Medical Sciences and health care facilities in general |
| Chinese Classification: | C50-Sanitation in general |
| Professional Classification: | WS-Hygiene |
| Related Keywords: | isotope dilution liquid chromatography
tandem mass spectrometry introduction core changes triple quadrupole mass spectrometer hours mass calibration cycle blank matrix control low concentration quality control product |
Introduction
Core changes in the standard revision
| Technical elements | 2015 edition | 2024 edition | Update points |
|---|---|---|---|
| Detection principle | Single standard detection | Simultaneous detection of dual standards | New 25(OH)VD₂ detection system |
| Internal standard requirements | Purity not specified | ≥97% isotope labeling | Use deuterated internal standard |
| Linear range | 10-100ng/mL | 5-200ng/mL | Expand clinical detection window |
Analysis of key technologies
1. Pretreatment optimization
Using n-hexane-ethyl acetate (1:1) mixed solvent extraction, compared with the previous standard:
- The recovery rate is increased to 95-105%
- The matrix effect is reduced to <15%
2. Chromatographic conditions
Reverse phase pentafluorophenyl column is recommended, key parameters:
Case: The validation data of Peking Union Medical College Hospital showed that at a flow rate of 0.5mL/min, the retention time of 25(OH)VD₃ was 6.2±0.3min, and the separation degree from the internal standard was >1.5
Method validation requirements
| Indicators | Acceptance criteria | Verification frequency |
|---|---|---|
| Precision | CV≤15% | Each batch of testing |
| Accuracy | ±15% target value | New batch of reagents |
| LOD | S/N≥3 | When the method is established |
Implementation Suggestions
1. Quality Control Strategy
It is recommended to use triple quality control:
- Blank matrix control
- Low concentration quality control product (20ng/mL)
- High concentration quality control product (150ng/mL)
2. Instrument Maintenance
For triple quadrupole mass spectrometer:
- APCI source cleaned every 500 hours
- Mass calibration cycle ≤ 6 months
Standard Evolution Analysis
This standard refers to the framework of US CLSI C62-A (2014), with the following major technical improvements:
- Introduction of dual-channel MRM detection technology
- Clarify the stability requirements for frozen samples (-20℃/28 days)
- Add a new matrix effect evaluation clause
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