WS/T 630-2018 in English
VALIDDetection of antibody against Schistosoma japonicum - Indirect haemagglutination test
- Issued on:2018-09-26
- Implemented on:2019-04-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$233.00
本标准规定了检测日本血吸虫抗体的间接红细胞凝集试验。
本标准适用于各级疾病预防控制机构和医疗机构对人体血清中日本血吸虫抗体的检测。
Introduction
Analysis of the Standard's Core Content
This standard specifies the technical specifications for the indirect hemagglutination test (IHA) for detecting antibodies to Schistosoma japonicum. It is applicable to the testing of serum samples by medical institutions at all levels. The core testing principle involves coating the surface of healthy human "O" red blood cells with soluble egg antigens. The specific antigen-antibody binding produces visible agglutination.
Requirements for key instruments and reagents
| Category | Technical requirements | Key points of quality control |
|---|---|---|
| Benchtop centrifuge | Speed ≥2,500 r/min | Calibrate speed monthly |
| Freeze-dried sensitized red blood cells | Titer ≥1:640 (positive control) | Store in a dark place at -20℃ |
| Electric constant temperature water bath | Temperature control accuracy ±0.5℃ | Daily temperature records |
Critical Control Points of the Testing Process
Sample Processing: After venous blood collection, serum separation must be completed within 4 hours to prevent hemolysis from affecting the results. Frozen samples should avoid repeated freeze-thaw cycles and should be centrifuged to remove precipitates after thawing.
Reagent Reconstitution: Freeze-dried sensitized red blood cells must be accurately reconstituted with the matching diluent to 1mL. Excessive shaking can cause red blood cell fragmentation. Verification of the positive control serum titer is a key quality control measure.
Reaction Interpretation: After incubation at 37℃ for 30±2 minutes, the assay must be read immediately. Delayed observation may result in false negatives. The agglutination strength should be determined by referring to the standard pattern diagram.
Technological Evolution and Standard Significance
This standard primarily improves upon WS 261-2006: ① Clarification of process parameters for the preparation of soluble egg antigens; ② Standardization of the sucrose preservative concentration (10%) for freeze-dried, sensitized red blood cells; and ③ Addition of new requirements for micropipette accuracy. These improvements increase test sensitivity from 85% to 92%.
Implementation Recommendations
- Laboratories should establish dedicated cleaning procedures for hemagglutination plates to prevent cross-contamination.
- Each batch of testing must include a positive and negative control, with the titer of the negative control ≤1:5.
- ELISA verification is recommended for critical value samples (1:10).
- Screening in epidemic areas is recommended to be combined with pathogen testing to improve specificity.
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