Gomes Luciano T, Tada Mauro S, Katsuragawa Tony H, Povoa Marinete M, Viana Giselle Mr, Alecrim Maria das Gracas C, De Santana-Filho Frankllin S, Arcanjo Ana Ruth L, Couto Alvaro A R A, Calvosa Vanja S P, Nery Andreia F, Fontes Cor J F
Núcleo de Estudos de Doenças Infecciosas, Universidade Federal de Mato Grosso, Cuiabá (MT), Brazil.
J Infect Dev Ctries. 2013 Mar 14;7(3):243-52. doi: 10.3855/jidc.2564.
In remote areas of the Amazon Region, diagnosis of malaria by microscopy is practically impossible. This study aimed to evaluate the performance of two rapid diagnostic tests (RDTs) targeting different malaria antigens stored at room temperature in the Brazilian Amazon Region.
Performance of the OptiMal Pf/Pan test and ICT-Now Pf/Pan test was analyzed retrospectively in 1,627 and 1,602 blood samples, respectively. Tests were performed over a 15-month period. Kits were stored at room temperature in five community health centres located in the Brazilian Amazon Region. RDT results were compared with thick blood smear (TBS) results to determine sensitivity, specificity, and accuracy of the RDT.
The sensitivities of the OptiMal Pf/Pan test were 79.7% for Plasmodium falciparum malaria diagnosis and 85.7% for non-P. falciparum infections. The results showed a crude agreement of 88.5% for P. falciparum, and 88.3% for non-P. falciparum infections (Kappa index = 0.74 and 0.75, respectively). For the ICT-Now Pf/Pan test (CI 95%), the sensitivities were 87.9% for P. falciparum malaria diagnosis and 72.5% for non-P. falciparum infection. Crude agreement between the ICT-Now Pf/Pan test and TBS was 91.4% for P. falciparum and 79.7% for non-P. falciparum infection. The Kappa index was 0.81 and 0.59 for the final diagnosis of P. falciparum and non-P. falciparum, respectively. Higher levels of parasitaemia were associated with higher crude agreement between RDT and TBS.
The sensitivities of RDTs stored at room temperature over a 15-month period and performed in field conditions were lower than those previously reported.
在亚马逊地区的偏远地区，通过显微镜诊断疟疾几乎是不可能的。本研究旨在评估在巴西亚马逊地区室温下储存的两种针对不同疟疾抗原的快速诊断测试（RDT）的性能。
分别对1627份和1602份血样进行回顾性分析，评估OptiMal Pf/Pan测试和ICT-Now Pf/Pan测试的性能。测试在15个月内进行。试剂盒在位于巴西亚马逊地区的五个社区卫生中心室温下储存。将RDT结果与厚血涂片（TBS）结果进行比较，以确定RDT的敏感性、特异性和准确性。
OptiMal Pf/Pan测试对恶性疟原虫疟疾诊断的敏感性为79.7%，对非恶性疟原虫感染的敏感性为85.7%。结果显示，恶性疟原虫的总体一致性为88.5%，非恶性疟原虫感染的总体一致性为88.3%（卡帕指数分别为0.74和0.75）。对于ICT-Now Pf/Pan测试（95%置信区间），恶性疟原虫疟疾诊断的敏感性为87.9%，非恶性疟原虫感染的敏感性为72.5%。ICT-Now Pf/Pan测试与TBS之间，恶性疟原虫的总体一致性为91.4%，非恶性疟原虫感染的总体一致性为79.7%。恶性疟原虫和非恶性疟原虫最终诊断的卡帕指数分别为0.81和0.59。较高的寄生虫血症水平与RDT和TBS之间较高的总体一致性相关。
在现场条件下，室温储存15个月的RDT的敏感性低于先前报道的水平。
