French Guiana (FG) is a French overseas territory where malaria is endemic. The current incidence rate is 0.74‰ inhabitants, and Plasmodium vivax is widely predominating even though Plasmodium falciparum is still present due to imported cases mainly from Africa. In FG, rapid diagnostic test (SD Malaria Ag P.f/Pan®) is based on the detection of pan-pLDH, PfHRP2, and PfHRP3 antigens, while in South America, the share of deletion of PfHRP2 gene is significantly increasing. Accordingly, the study questions the reliability of RDTs in the Amazonian context. The study is retrospective. It is conducted over 4 years and analysed 12,880 rapid diagnostic tests (RDTs) compared to concomitant Blood Film Tests (BFTs) sampled for malaria diagnosis. The global assessment of the accuracy of SD Malaria Ag P.f/Pan® in the diagnostic of malaria shows both Positive and Negative Predictive Values (PPV and NPV) higher than 95%, except for PPV in the diagnosis of malaria to P. falciparum (88%). Overall, the concordance rate between RDT and BFT (positive/positive; negative/negative) was 99.5%. The PPV of the RDT in the follow-up of patients diagnosed with P. falciparum was the lowest during the first 28 days. The PPV of the RDT in the follow-up of patients diagnosed with P. vivax was the lowest during the first 21 days. The global sensitivity of SD Malaria Ag P.f/Pan® test was, on average, 96% (88.2–100) for P. falciparum and 93% (90.6–94.2) for P. vivax. The global specificity was 99.8% (99.5–100) for all included species. SD Malaria Ag P.f/Pan® is a reliable rapid test used for the first-line diagnosis in remote healthcare centres. The test results should be interpreted in the light of patient’s recent medical history and the date of arrival to FG.

中文翻译：

---

SD Malaria Ag Pf/Pan® 在法国亚马逊地区作为快速诊断测试的准确性

法属圭亚那 (FG) 是法国的海外领土，疟疾流行。目前的发病率为0.74‰居民，尽管恶性疟原虫仍然存在，但由于主要来自非洲的输入病例，间日疟原虫仍广泛占主导地位。在FG中，快速诊断检测（SD Malaria Ag Pf/Pan®）是基于pan-pLDH、PfHRP2和PfHRP3抗原的检测，而在南美洲，PfHRP2基因缺失的比例正在显着增加。因此，该研究质疑 RDT 在亚马逊环境中的可靠性。该研究是回顾性的。它进行了 4 年多，并分析了 12,880 次快速诊断测试 (RDT) 与用于疟疾诊断的伴随血膜测试 (BFT) 进行比较。SD Malaria Ag P 准确性的全球评估。f/Pan® 在疟疾诊断中的阳性和阴性预测值（PPV 和 NPV）均高于 95%，但在诊断恶性疟原虫的疟疾中的 PPV (88%) 除外。总体而言，RDT 和 BFT 之间的一致性（阳性/阳性；阴性/阴性）为 99.5%。在诊断为恶性疟原虫的患者的随访中，RDT 的 PPV 在前 28 天内最低。在诊断为间日疟原虫的患者的随访中，RDT 的 PPV 在前 21 天内最低。SD Malaria Ag Pf/Pan® 测试的全球敏感性平均为恶性疟原虫 96% (88.2–100) 和间日疟原虫 93% (90.6–94.2)。所有纳入物种的全球特异性为 99.8% (99.5-100)。SD Malaria Ag Pf/Pan® 是一种可靠的快速测试，用于远程医疗中心的一线诊断。