Performance of an ultra-sensitive Plasmodium falciparum HRP2-based rapid diagnostic test with recombinant HRP2, culture parasites, and archived whole blood samples.
Performance of an ultra-sensitive Plasmodium falciparum HRP2-based rapid diagnostic test with recombinant HRP2, culture parasites, and archived whole blood samples.
复制标题
DOI：
10.1186/s12936-018-2268-7
复制
发表时间：
2018-03-17
期刊：
影响因子：
3
通讯作者：
Domingo GJ
中科院分区：
文献类型：
--
作者：
Das S;Peck RB;Barney R;Jang IK;Kahn M;Zhu M;Domingo GJ
随着疟疾流行国家从控制转向消灭，低密度恶性疟原虫感染的比例增加。目前的现场诊断工具，如显微镜和快速诊断试验（RDT），检测限分别约为100-200寄生虫/微升（p/微升）和800-1000 pg/mL富含组氨酸的蛋白2（HRP 2），无法检测这些感染。在实验室条件下评价了一种新型超灵敏的基于HRP 2的Alere™ Malaria Ag P.f RDT（uRDT），以确定该检测试剂盒对重组HRP 2和天然培养寄生虫的性能。uRDT检测到恶性疟原虫重组GST-W2和FliS-W2以及培养的W2和ITG的稀释液，其在全血中稀释至10-40 pg/mL HRP 2，这取决于所测试的蛋白质。对123份存档的冷冻全血样本，uRDT特异性为100%。使用pfhrp 2基因缺失菌株D10和Dd 2、pfhrp 3基因缺失菌株HB 3、对照pfhrp 2和pfhrp 3双缺失菌株3BD 5和pfhrp 2和pfhrp 3感受态菌株ITG研究了与HRP 3的快速检测交叉反应性。商业标准诊断公司BIOLINE Malaria Ag P.f RDT（SD-RDT）和uRDT检测到的pfhrp 2阳性菌株分别低至49和3.13 p/µL。两种检测均检出pfhrp 2缺失菌株，浓度低至98 p/µL。uRDT的性能根据蛋白质而变化，但总体上显示出比SD-RDT提高10倍以上。uRDT也表现出良好的特异性，并显示与HRP 3相同的交叉反应性作为SD-RDT。总之，结果支持uRDT作为一种更敏感的HRP 2测试，可能是消除运动中的一种潜在有效的工具。为此，需要进一步的临床评价。
As malaria endemic countries shift from control to elimination, the proportion of low density Plasmodium falciparum infections increases. Current field diagnostic tools, such as microscopy and rapid diagnostic tests (RDT), with detection limits of approximately 100–200 parasites/µL (p/µL) and 800–1000 pg/mL histidine-rich protein 2 (HRP2), respectively, are unable to detect these infections. A novel ultra-sensitive HRP2-based Alere™ Malaria Ag P.f RDT (uRDT) was evaluated in laboratory conditions to define the test’s performance against recombinant HRP2 and native cultured parasites. The uRDT detected dilutions of P. falciparum recombinant GST-W2 and FliS-W2, as well as cultured W2 and ITG, diluted in whole blood down to 10–40 pg/mL HRP2, depending on the protein tested. uRDT specificity was 100% against 123 archived frozen whole blood samples. Rapid test cross-reactivity with HRP3 was investigated using pfhrp2 gene deletion strains D10 and Dd2, pfhrp3 gene deletion strain HB3, and controls pfhrp2 and pfhrp3 double deletion strain 3BD5 and pfhrp2 and pfhrp3 competent strain ITG. The commercial Standard Diagnostics, Inc. BIOLINE Malaria Ag P.f RDT (SD-RDT) and uRDT detected pfhrp2 positive strains down to 49 and 3.13 p/µL, respectively. The pfhrp2 deletion strains were detected down to 98 p/µL by both tests. The performance of the uRDT was variable depending on the protein, but overall showed a greater than 10-fold improvement over the SD-RDT. The uRDT also exhibited excellent specificity and showed the same cross-reactivity with HRP3 as the SD-RDT. Together, the results support the uRDT as a more sensitive HRP2 test that could be a potentially effective tool in elimination campaigns. Further clinical evaluations for this purpose are merited.
登录
查看更多内容
影响因子：
9.8
作者：
Hemingway J;Shretta R;Wells TN;Bell D;Djimdé AA;Achee N;Qi G
通讯作者：
Qi G
影响因子：
3
作者：
Parker DM;Landier J;von Seidlein L;Dondorp A;White L;Hanboonkunupakarn B;Maude RJ;Nosten FH
通讯作者：
Nosten FH
影响因子：
64.8
作者：
Slater, Hannah C.;Ross, Amanda;Ghani, Azra C.
通讯作者：
Ghani, Azra C.
DOI：
10.4269/ajtmh.17-0245
发表时间：
2017-11
期刊：
The American journal of tropical medicine and hygiene
影响因子：
--
作者：
Das S;Jang IK;Barney B;Peck R;Rek JC;Arinaitwe E;Adrama H;Murphy M;Imwong M;Ling CL;Proux S;Haohankhunnatham W;Rist M;Seilie AM;Hanron A;Daza G;Chang M;Nakamura T;Kalnoky M;Labarre P;Murphy SC;McCarthy JS;Nosten F;Greenhouse B;Allauzen S;Domingo GJ
通讯作者：
Domingo GJ
影响因子：
6.4
作者：
Baker, J;McCarthy, J;Cheng, Q
通讯作者：
Cheng, Q