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Background <p>Recent reports documented catastrophic sensitivity failures (18%) of Abbott-Bioline™ Malaria Ag <i>Pf/Pv</i> rapid diagnostic tests (RDTs) at the Thailand-Myanmar border, prompting WHO to issue an information notice on quality concerns. We evaluated the same RDT lots under controlled laboratory conditions and in a high-transmission field setting in Madagascar to assess whether performance varied across epidemiological contexts.</p> Methods <p>Laboratory evaluation tested four Abbott-Bioline™ Malaria Ag <i>Pf/Pv</i> lots (05DDI018BH, 05DDI020BA, 05DDI041AB, 05DDI040AA) using serial dilutions of cultured <i>Plasmodium falciparum</i> (0–60,784 parasites/µL). Field evaluation enrolled 218 consecutive febrile patients at Ranomafana health centre, southeastern Madagascar. Performance of both RDTs (Abbott-Bioline™ Malaria Ag <i>Pf/Pv</i> and Parascreen® Malaria Ag <i>Pf/Pan</i>) was assessed against microscopy and real-time PCR as reference standards.</p> Results <p>In laboratory testing, substantial inter-lot variability was observed, with detection failures occurring between 97 and 373 parasites/µL. Incomplete blood migration and faint test lines were noted at lower densities. In the field, malaria prevalence was 70.2% by PCR and 48.6% by microscopy. Against microscopy, Abbott-Bioline™ Malaria Ag <i>Pf/Pv</i> achieved sensitivity of 99.1% (95% CI 94.9–100) and specificity of 93.7% (95% CI 87.4–97.4). Parascreen® Malaria Ag <i>Pf/Pan</i> showed sensitivity of 100% (95% CI 96.6–100) and specificity of 92.8% (95% CI 86.3–96.8). Against PCR, sensitivity decreased to 73.2% for Abbott-Bioline™ Malaria Ag <i>Pf/Pv</i> and 74.5% for Parascreen® Malaria Ag <i>Pf/Pan</i>, while specificity remained 98.5% for both tests. No significant difference was observed between RDTs (p &gt; 0.05).</p> Conclusions <p>Despite using identical lots that showed 18% sensitivity at the Thailand-Myanmar border, Abbott-Bioline™ Malaria Ag <i>Pf/Pv</i> RDTs achieved 99.1% sensitivity in Madagascar. This difference likely reflects higher parasite densities in the Malagasy high-transmission setting (geometric mean 10,006 parasites/µL) compared to low-transmission elimination contexts. Both RDTs met WHO performance thresholds against microscopy but missed approximately 25% of PCR-positive infections. These findings demonstrate that RDT performance is highly context-dependent and underscore the need for enhanced post-deployment surveillance.</p>

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Field and laboratory evaluation of Abbott-Bioline™ Malaria Ag Pf/Pv RDT performance in a high-transmission setting: contrasting results with a low-endemic area

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月18日

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  • Jocia Fenomanana,
  • Anthony Ravoavy,
  • Malalanandrianina Rakotoarisoa,
  • Lucien Platon,
  • Alioune Wade,
  • Buze Chala,
  • Yssimini Nadège Guillène Tibiri,
  • Allan Muller,
  • Lucas Thiebaut,
  • Emmanuelle Caspar,
  • Pierre-Emeric Strubel,
  • Didier Ménard,
  • Arsène Ratsimbasoa

摘要

Background

Recent reports documented catastrophic sensitivity failures (18%) of Abbott-Bioline™ Malaria Ag Pf/Pv rapid diagnostic tests (RDTs) at the Thailand-Myanmar border, prompting WHO to issue an information notice on quality concerns. We evaluated the same RDT lots under controlled laboratory conditions and in a high-transmission field setting in Madagascar to assess whether performance varied across epidemiological contexts.

Methods

Laboratory evaluation tested four Abbott-Bioline™ Malaria Ag Pf/Pv lots (05DDI018BH, 05DDI020BA, 05DDI041AB, 05DDI040AA) using serial dilutions of cultured Plasmodium falciparum (0–60,784 parasites/µL). Field evaluation enrolled 218 consecutive febrile patients at Ranomafana health centre, southeastern Madagascar. Performance of both RDTs (Abbott-Bioline™ Malaria Ag Pf/Pv and Parascreen® Malaria Ag Pf/Pan) was assessed against microscopy and real-time PCR as reference standards.

Results

In laboratory testing, substantial inter-lot variability was observed, with detection failures occurring between 97 and 373 parasites/µL. Incomplete blood migration and faint test lines were noted at lower densities. In the field, malaria prevalence was 70.2% by PCR and 48.6% by microscopy. Against microscopy, Abbott-Bioline™ Malaria Ag Pf/Pv achieved sensitivity of 99.1% (95% CI 94.9–100) and specificity of 93.7% (95% CI 87.4–97.4). Parascreen® Malaria Ag Pf/Pan showed sensitivity of 100% (95% CI 96.6–100) and specificity of 92.8% (95% CI 86.3–96.8). Against PCR, sensitivity decreased to 73.2% for Abbott-Bioline™ Malaria Ag Pf/Pv and 74.5% for Parascreen® Malaria Ag Pf/Pan, while specificity remained 98.5% for both tests. No significant difference was observed between RDTs (p > 0.05).

Conclusions

Despite using identical lots that showed 18% sensitivity at the Thailand-Myanmar border, Abbott-Bioline™ Malaria Ag Pf/Pv RDTs achieved 99.1% sensitivity in Madagascar. This difference likely reflects higher parasite densities in the Malagasy high-transmission setting (geometric mean 10,006 parasites/µL) compared to low-transmission elimination contexts. Both RDTs met WHO performance thresholds against microscopy but missed approximately 25% of PCR-positive infections. These findings demonstrate that RDT performance is highly context-dependent and underscore the need for enhanced post-deployment surveillance.