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在改变诊断方法为 RDT 之前的知情决策:苏丹东部卡萨拉使用显微镜、快速诊断检测和分子技术诊断和鉴定疟原虫的比较。

Informed decision-making before changing to RDT: a comparison of microscopy, rapid diagnostic test and molecular techniques for the diagnosis and identification of malaria parasites in Kassala, eastern Sudan.

机构信息

Faculty of Medicine, Kassala University, Kassala, Sudan.

出版信息

Trop Med Int Health. 2010 Dec;15(12):1442-8. doi: 10.1111/j.1365-3156.2010.02659.x. Epub 2010 Oct 25.

Abstract

OBJECTIVES

Rapid diagnostic tests (RDTs) are promoted for the diagnosis of malaria in many countries. The question arises whether laboratories where the current method of diagnosis is microscopy should also switch to RDT. This problem was studied in Kassala, Sudan where the issue of switching to RDT is under discussion.

METHODS

Two hundred and three blood samples were collected from febrile patients suspected of having malaria. These were subsequently analysed with microscopy, RDT (SD Bioline P.f/P.v) and PCR for the detection and identification of Plasmodium parasites.

RESULTS

Malaria parasites were detected in 36 blood samples when examined microscopically, 54 (26.6%) samples were found positive for malaria parasites by RDT, and 44 samples were positive by PCR. Further analysis showed that the RDT used in our study resulted in a relatively high number of false positive samples. When microscopy was compared with PCR, an agreement of 96.1% and k = 0.88 (sensitivity 85.7% and specificity 100%) was found. However, when RDT was compared with PCR, an agreement of only 81.2 and k = 0.48 (sensitivity 69% and specificity 84%) was found.

CONCLUSION

PCR has proven to be one of the most specific and sensitive diagnostic methods, particularly for malaria cases with low parasitaemia. However, this technique has limitations in its routine use under resource-limited conditions, such as our study location. At present, based on these results, microscopy remains the best option for routine diagnosis of malaria in Kassala, eastern Sudan.

摘要

目的

快速诊断检测(RDT)在许多国家都被用于疟疾诊断。问题是,当前采用显微镜诊断方法的实验室是否也应该转向 RDT。苏丹卡萨拉正在讨论这个问题,本研究就是在那里进行的。

方法

从疑似患有疟疾的发热患者中采集了 203 份血样。随后使用显微镜、RDT(SD Bioline P.f/P.v)和 PCR 对这些血样进行分析,以检测和鉴定疟原虫。

结果

用显微镜检查时,在 36 份血样中发现了疟原虫,RDT 检测到 54 份(26.6%)血样疟原虫阳性,PCR 检测到 44 份血样疟原虫阳性。进一步分析表明,我们研究中使用的 RDT 导致了相对较多的假阳性样本。将显微镜与 PCR 进行比较时,发现一致性为 96.1%,k 值为 0.88(灵敏度为 85.7%,特异性为 100%)。然而,将 RDT 与 PCR 进行比较时,发现一致性仅为 81.2%,k 值为 0.48(灵敏度为 69%,特异性为 84%)。

结论

PCR 已被证明是最特异和敏感的诊断方法之一,特别是对于寄生虫血症较低的疟疾病例。然而,在资源有限的情况下,如我们的研究地点,这种技术在常规使用中存在局限性。目前,基于这些结果,显微镜仍然是苏丹东部卡萨拉地区疟疾常规诊断的最佳选择。

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