Optimal-IT® 检测在治疗科特迪瓦农村地区确诊疟疾病例中的性能和临床实用性。

MalariaWorld journal Pub Date : 2014-12-04 eCollection Date: 2014-01-01 DOI:10.5281/zenodo.10887947
Yapo T Aba, Emmanuel Bissagnené, Ouffoué Kra, Serge B Assi, Raoul Moh, Pulchérie Goly, Nogbou Ello, Alain Kassi, Bessy R Yao, Franklin Abouo, Eboi Ehui
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引用次数: 0

摘要

背景:在非洲,疟疾治疗大多基于临床推断,并在数年内对所有发热病例普遍应用抗疟治疗。如果使用功能强大且可靠的快速诊断检测,仅限于确诊病例的治疗可能会遏制将发烧等同于疟疾的做法、抗疟疾药物滥用和疟原虫抗药性的扩大。本研究旨在确定 Optimal-IT® 检验在农村地区无并发症疟疾独家治疗策略中的性能:在科特迪瓦圣佩德罗森林地区进行的一项前瞻性研究纳入了临床症状为无并发症疟疾的患者,他们同意接受厚血片(TBF)、血涂片(BS)和 Optimal-IT®(基于 pLDH)检测。快速诊断检测(RDT)结果用于决定疟疾治疗,然后与 TBF/BS 结果(参考)进行比较,以评估 RDT 的性能和临床实用性:结果:384 名患者(209 名男性,175 名女性)的平均年龄为 28 岁,平均气温为 38.1°C。92% 的患者 TBF/BS 和 Optimal-IT® 检测结果一致,但有 10 例假阴性(3%)和 19 例假阳性(5%)患者检测结果不一致。恶性疟原虫的平均寄生虫密度为 25,600 滋养体/μl。计算得出的结果表明:灵敏度=95%,特异性=91%,阳性预测值=90%,阴性预测值=95%,阳性似然比=10,阴性似然比=0.06,诊断几率比=166,这表明 Optimal-IT® 是一种强大而可靠的诊断工具。接受治疗的 193 名 RDT 阳性患者均已痊愈,尽管在第 17 天、第 25 天和第 27 天分别有 3 例复发病例。RDT 阴性患者接受了各种治疗(抗生素、扑热息痛),但其中有两名患者在第 7 天再次感染疟疾。结论:Optimal-IT® 检测法是一种有效的疟疾检测方法:已在实地使用的 Optimal-IT® 检测方法在有效检测疟疾患者和非疟疾患者方面表现良好。因此,它适用于仅限于确诊病例的疟疾治疗策略。
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Performance and clinical usefulness of the Optimal-IT® test in the treatment of confirmed malaria cases in rural areas in Côte d'Ivoire.

Background: In Africa, malaria care is mostly based on clinical presumption and the general application of antimalarial treatment to all febrile episodes over several years. Treatment limited to confirmed cases might curb the practice of equating fever with malaria, antimalarial drug abuse and the extension of Plasmodium resistance, provided that powerful and reliable rapid diagnostic tests are used. This study aimed at determining the performances of the Optimal-IT® test in the strategy for the exclusive treatment of uncomplicated malaria in rural areas.

Materials and methods: A prospective study conducted in the forest region of San Pedro, Côte d'Ivoire, included patients exhibiting clinical signs of uncomplicated malaria who gave their consent and benefited from thick blood film (TBF), blood smear (BS) and Optimal-IT® (pLDH-based) test. Rapid diagnostic test (RDT) results were taken into consideration to decide on malaria treatment and then compared with TBF/BS results (reference) to assess the performances and clinical usefulness of the RDT.

Results: The mean age of the 384 patients included (209 men, 175 women) was 28 years and the mean temperature was 38.1°C. TBF/BS and Optimal-IT® were concordant in 92% of patients but discordant in 10 false negative (3%) and 19 false-positive patients (5%). The average parasite density of P. falciparum was 25,600 trophozoites/μl. The performances calculated were: sensitivity=95%, specificity=91%, positive predictive value=90%, negative predictive value=95%, positive likelihood ratio=10, negative likelihood ratio=0.06 and diagnostic odds ratio=166, indicating that Optimal-IT® is a powerful and credible diagnostic tool. The 193 RDT-positive patients treated were healed, despite three recurrence cases at day (D) D17, D25 and D27, respectively. RDT-negative patients received various treatments (antibiotics, paracetamol), but two patients among them presented with a bout of malaria on D7. None of the previously untreated patients returned with severe malaria.

Conclusions: The Optimal-IT® test, which is already used in the field, showed good performances to effectively detect patients with and without malaria. It is therefore adapted to the malaria treatment strategy limited to confirmed cases.

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