Institut de Recherche pour le Développement (IRD), Université de la Méditerranée, Marseille, France.
Acta Trop. 2013 Feb;125(2):214-9. doi: 10.1016/j.actatropica.2012.10.002. Epub 2012 Oct 17.
Rapid diagnostic tests (RDTs) are affordable, alternative diagnostic tools. The present study aimed to evaluate RDTs available in Cameroon and compare their characteristics to follow the parasitological response of patients for 28 days. Malaria diagnosis was assessed in 179 febrile patients using conventional microscopy as the reference method. Parascreen detects both Plasmodium falciparum-specific histidine-rich protein 2 (Pf HRP-2) and Pan-specific plasmodial lactate dehydrogenase (pLDH) in all four human Plasmodium spp. Diaspot is based on the detection of Pf HRP-2. OptiMAL-IT (pLDH specific for P. falciparum and pLDH for all four human Plasmodium spp.) was assessed for comparison. The reliability of RDTs was evaluated by calculating the sensitivity, specificity, positive predictive value, negative predictive value, false-positive rate, false-negative rate, and likelihood ratio. The clinical outcome of 18 children treated with atovaquone-proguanil and followed for 28 days was evaluated using microscopy and RDTs. Of 179 samples, 133 (74.3%) were pure P. falciparum-positive smears, 4 (2.2%) pure P. malariae-positive smears, and 42 (23.5%) negative smears. Parascreen and Diaspot had high sensitivity (>92%) and positive predictive values (>94%). The specificities for Parascreen and Diaspot were 81.0% and 90.5%, respectively. The false-positive rates and the false-negative rates were 19.0% and 4.5% for Parascreen and 9.5% and 8.3% for Diaspot, respectively. Most false-negatives occurred in samples with low parasitaemia (<500 asexual parasites/μL). The performance of RDTs was better at higher parasitaemia (>500 asexual parasites/μL). Four pure P. malariae were only detected by the pan-Plasmodium bands of Parascreen and OptiMAL-IT. In blood samples from patients treated and followed-up for 28 days, HRP2-based RDTs remained positive in most samples until Day 28. Despite negative smears, OptiMAL-IT remained positive in several patients until Day 7 but was negative in all patients from Day 14 onwards. RDTs can improve the management of febrile patients. The validity, ease of use, and cost of HRP2-based tests were comparable. However, one of the current weaknesses of the RDT-based strategy using the tests available in Cameroon is inadequate sensitivity for low parasitaemia. In some cases, RDT results may require correct interpretation based on clinical history, clinical examination, and microscopic diagnosis.
快速诊断检测(RDTs)是一种价格实惠的替代诊断工具。本研究旨在评估喀麦隆现有的 RDT,并比较它们的特性,以跟踪患者 28 天的寄生虫学反应。使用常规显微镜作为参考方法,对 179 名发热患者进行疟疾诊断评估。Parascreen 可检测所有四种人类疟原虫的恶性疟原虫特异性组氨酸丰富蛋白 2(Pf HRP-2)和泛原虫乳酸脱氢酶(pLDH)。Diaspot 基于 Pf HRP-2 的检测。OptiMAL-IT(针对 P. falciparum 的 pLDH 和所有四种人类疟原虫的 pLDH)被评估以进行比较。通过计算灵敏度、特异性、阳性预测值、阴性预测值、假阳性率、假阴性率和似然比来评估 RDT 的可靠性。用显微镜和 RDT 评估了 18 名接受阿托伐醌-磺胺多辛治疗并随访 28 天的儿童的临床结果。在 179 个样本中,133 个(74.3%)为纯恶性疟原虫阳性涂片,4 个(2.2%)为纯疟原虫阳性涂片,42 个(23.5%)为阴性涂片。Parascreen 和 Diaspot 的灵敏度均高于 92%,阳性预测值均高于 94%。Parascreen 和 Diaspot 的特异性分别为 81.0%和 90.5%。Parascreen 的假阳性率和假阴性率分别为 19.0%和 4.5%,Diaspot 的假阳性率和假阴性率分别为 9.5%和 8.3%。大多数假阴性发生在寄生虫血症较低的样本中(<500 个无性体/μL)。在寄生虫血症较高的情况下(>500 个无性体/μL),RDT 的性能更好。四种纯疟原虫仅在 Parascreen 和 OptiMAL-IT 的泛疟原虫带中被检测到。在接受治疗并随访 28 天的患者的血液样本中,基于 HRP2 的 RDT 在大多数样本中直到第 28 天仍为阳性。尽管涂片阴性,但 OptiMAL-IT 在数名患者中直至第 7 天仍为阳性,但从第 14 天起所有患者均为阴性。RDT 可改善发热患者的治疗管理。基于 HRP2 的检测的有效性、易用性和成本相当。然而,喀麦隆现有的 RDT 策略的一个当前弱点是对低寄生虫血症的敏感性不足。在某些情况下,RDT 结果可能需要根据临床病史、临床检查和显微镜诊断进行正确解释。