SN/T 4793-2017 in English
VALIDTest methods for Plasmodium by real time PCR at ports
- Issued on:2017-05-12
- Implemented on:2017-12-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$117.00
Introduction
Analysis of the core content of the standard
This standard establishes a complete molecular detection system for Plasmodium, using equipment such as fluorescence quantitative PCR instrument to achieve differential diagnosis of four types of human Plasmodium through specific primer and probe combinations. Technical points include:
| Assay Type | Target Gene | Probe Type | Melting Temperature (℃) |
|---|---|---|---|
| Universal Assay | Conserved Sequence | FAM-MGB | - |
| Plasmodium falciparum | Specific Fragment | FAM-BHQ1 | - |
| Plasmodium ovale | Species Specific Sequence | SYBR Green | 72.5 |
Key Technical Parameters
Sample Requirements: 3-5 mL of venous blood should be collected into EDTA anticoagulant tubes and stored at -20°C to avoid repeated freezing and thawing.
Amplification System: 25 μL standard reaction volume, containing 12.5 μL 2× MasterMix and specific primers and probes.
Cycling Parameters: Initial denaturation at 95°C for 5 min, followed by 40 cycles (95°C for 10 s → 58°C for 45 s).
Implementation Points
1. Biosafety: Experimental operations must be performed in a Class IIA Biosafety Cabinet in accordance with GB19489 requirements.
2. Quality Control Requirements: Negative and positive controls must be set up, and the Ct value of the positive control should be <35
3. Result Interpretation:
- Positive: Ct ≤ 35 and a typical amplification curve
- Suspicious: 35
- Negative: No amplification curve
Application Value of the Standard
This standard establishes a standardized molecular detection process for malaria at ports of entry for the first time. Compared with traditional microscopy methods:
- Sensitivity is increased by 100 times (0.1 parasites/μL blood can be detected)
- Detection time is shortened to 4 hours
- Accurate typing of the four Plasmodium species is achieved

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