Department of Veterinary Parasitology and Microbiology, Makerere University, Kampala, Uganda.
Trop Med Int Health. 2010 Jul;15(7):800-5. doi: 10.1111/j.1365-3156.2010.02547.x. Epub 2010 May 14.
To evaluate the repeatability and reproducibility of four simplified molecular assays for the diagnosis of Trypanosoma brucei spp. or Leishmania ssp. in a multicentre ring trial with seven participating laboratories.
The tests are based on PCR or NASBA amplification of the parasites nucleic acids followed by rapid read-out by oligochromatographic dipstick (PCR-OC and NASBA-OC).
On purified nucleic acid specimens, the repeatability and reproducibility of the tests were Tryp-PRC-OC, 91.7% and 95.5%; Tryp-NASBA-OC, 95.8% and 100%; Leish-PCR-OC, 95.9% and 98.1%; Leish-NASBA-OC, 92.3% and 98.2%. On blood specimens spiked with parasites, the repeatability and reproducibility of the tests were Tryp-PRC-OC, 78.4% and 86.6%; Tryp-NASBA-OC, 81.5% and 89.0%; Leish-PCR-OC, 87.1% and 91.7%; Leish-NASBA-OC, 74.8% and 86.2%.
As repeatability and reproducibility of the tests were satisfactory, further phase II and III evaluations in clinical and population specimens from disease endemic countries are justified.
在一项有 7 个参与实验室的多中心环试验中，评估 4 种简化分子检测方法对诊断布氏锥虫 spp.或利什曼原虫 spp.的重复性和重现性。
这些检测方法基于寄生虫核酸的 PCR 或 NASBA 扩增，随后通过寡核苷酸条带（PCR-OC 和 NASBA-OC）快速读取。
在纯化的核酸标本上，检测方法的重复性和重现性分别为 Tryp-PRC-OC，91.7%和 95.5%；Tryp-NASBA-OC，95.8%和 100%；Leish-PCR-OC，95.9%和 98.1%；Leish-NASBA-OC，92.3%和 98.2%。在含有寄生虫的血液标本上，检测方法的重复性和重现性分别为 Tryp-PRC-OC，78.4%和 86.6%；Tryp-NASBA-OC，81.5%和 89.0%；Leish-PCR-OC，87.1%和 91.7%；Leish-NASBA-OC，74.8%和 86.2%。
由于检测方法的重复性和重现性令人满意，因此有理由在疾病流行国家的临床和人群标本中进一步进行 II 期和 III 期评估。
