Mwangonela Zena E, Ye Young, Rachel Qin, Msuya Hajirani M, Mwamlima Tunu G, Mswata Sarah S, Chaki Prosper P, Kimaro Ester G, Mweya Clement N, Mpina Maxmillian G, Mwangoka Grace W
Ifakara Health Institute Bagamoyo Branch, P.O.Box 74, Bagamoyo, Tanzania.
The Nelson Mandela African Institution of Science and Technology, P.O.Box 447, Arusha, Tanzania.
Bull Natl Res Cent. 2023;47(1):17. doi: 10.1186/s42269-023-00992-4. Epub 2023 Feb 7.
Malaria rapid diagnostic tests (mRDTs) have played an important role in the early detection of clinical malaria in an endemic area. While several mRDTs are currently on the market, the availability of mRDTs with high sensitivity and specificity will merit the fight against malaria. We evaluated the field performance of a novel One Step Malaria (P.f/P.v) Tri-line and One Step Malaria (P.f) rapid test kits in Pwani, Tanzania.
In a cross-sectional study conducted in Bagamoyo and Kibiti districts in Tanzania, symptomatic patients were tested using the SD BIOLINE, One Step Malaria (P.f/P.v) Tri-line and One Step Malaria (P.f) rapid test kits, microscope, and quantitative Polymerase Chain Reaction (qPCR). An additional qPCR assay was carried out to detect Histidine-Rich Protein 2 (HRP-2) gene deletion on mRDT negative but microscope and qPCR positive samples. Microscope results confirmed by qPCR were used for analysis, where qPCR was used as a reference method.
The sensitivity and specificity of One Step P.f/P.v Tri-line mRDTs were 96.0% (CI 93.5-97.7%) and 98.3% (CI 96.8-99.2%), respectively. One Step P.f mRDT had sensitivity and specificity of 95.2% (CI 92.5-97.1%) and 97.9% (CI 96.3-99.0%) respectively. Positive predictive value (PPV) was 97.6% (CI 95.4-98.7%) and negative predictive value (NPV) was 96.2% (CI 95.5-98.3%) for the One Step P.f/P.v Tri-line mRDTs respectively, while One Step P.f mRDT had positive predictive value (PPV) and negative predictive value (NPV) of 97.0% (CI 94.8-98.3%) and 96.7 (CI 94.9-97.9%) respectively. 9.8% (CI 7.84-11.76) of all samples tested and reported to be malaria-negative by mRDT had HRP-2 gene deletion.
One Step Malaria P.f/P.v Tri-line and One Step Malaria P.f rapid test kits have similar sensitivity and specificity as the standard mRDT that is currently in the market, demonstrating the potential to contribute in the fight against malaria in endemic settings. However, the identified malaria parasites population with HRP-2 gene deletion pose a threat to the current mRDT usability in the field and warrants further investigations.
疟疾快速诊断检测（mRDTs）在疟疾流行地区临床疟疾的早期检测中发挥了重要作用。虽然目前市场上有几种mRDTs，但具有高灵敏度和特异性的mRDTs的可用性将有助于抗击疟疾。我们在坦桑尼亚的滨海省评估了一种新型一步法疟疾（恶性疟原虫/间日疟原虫）三线和一步法疟疾（恶性疟原虫）快速检测试剂盒的现场性能。
在坦桑尼亚的巴加莫约和基比蒂地区进行的一项横断面研究中，对有症状的患者使用SD BIOLINE、一步法疟疾（恶性疟原虫/间日疟原虫）三线和一步法疟疾（恶性疟原虫）快速检测试剂盒、显微镜和定量聚合酶链反应（qPCR）进行检测。对mRDT阴性但显微镜和qPCR阳性的样本进行额外的qPCR检测以检测富含组氨酸蛋白2（HRP-2）基因缺失。以qPCR作为参考方法，将经qPCR确认的显微镜结果用于分析。
一步法恶性疟原虫/间日疟原虫三线mRDTs的灵敏度和特异性分别为96.0%（93.5%-97.7%CI）和98.3%（96.8%-99.2%CI）。一步法恶性疟原虫mRDT的灵敏度和特异性分别为95.2%（92.5%-97.1%CI）和97.9%（96.3%-99.0%CI）。一步法恶性疟原虫/间日疟原虫三线mRDTs的阳性预测值（PPV）为97.6%（95.4%-98.7%CI），阴性预测值（NPV）为96.2%（95.5%-98.3%CI），而一步法恶性疟原虫mRDT的阳性预测值（PPV）和阴性预测值（NPV）分别为97.0%（94.8%-98.3%CI）和96.7（94.9%-97.9%CI）。所有经mRDT检测并报告为疟疾阴性的样本中有9.8%（7.84%-11.76%CI）存在HRP-2基因缺失。
一步法疟疾恶性疟原虫/间日疟原虫三线和一步法疟疾恶性疟原虫快速检测试剂盒与目前市场上的标准mRDT具有相似的灵敏度和特异性，表明其在疟疾流行地区抗击疟疾方面具有潜在贡献。然而，已鉴定出的具有HRP-2基因缺失的疟原虫群体对当前mRDT在现场的可用性构成威胁，需要进一步调查。
