Pouzol S, Uddin M K M, Islam A, Alam T, Jabin M S, Banu S, Hoffmann J
Medical and Expertise Division, Fondation Mérieux, Lyon, France.
Infectious Diseases Division, icddr,b, Dhaka-1212, Bangladesh.
IJTLD Open. 2025 Jul 9;2(7):397-403. doi: 10.5588/ijtldopen.24.0603. eCollection 2025 Jul.
The WHO recently updated the target product profile (TPP) for TB identification at the peripheral level to guide test development.
We conducted a prospective diagnostic accuracy study among outpatients under 15 years old with presumed pulmonary TB at the International Centre for Diarrheal Disease Research, Bangladesh (icddr,b) Dhaka Hospital. We evaluated the accuracy of the RISK6 assay and performed a cost-per-TB case identification analysis.
Of 365 enrolled children, 68 had microbiologically confirmed TB, 94 had unconfirmed TB and 203 were unlikely to have TB. RISK6 did not meet the TPP for TB diagnosis in children but in presumptive pulmonary TB individuals ≤ 12 months, the assay outperformed (32/42) both the Mantoux test (7/42) and chest X-ray (11/42) in correctly referring individuals for confirmatory testing. RISK6, alone or in combination with Mantoux test, was the most cost-effective strategy for identifying and confirming TB, with a cost as low as $US132.00 in children > 12 months.
Although RISK6 did not meet the WHO TPP for TB diagnosis, it shows promise as a triage test, especially for children ≤ 12 months, and could serve as a decision-support tool in integrated treatment algorithms recommended by the WHO.
世界卫生组织（WHO）最近更新了基层结核病识别的目标产品特性（TPP），以指导检测方法的开发。
我们在孟加拉国腹泻疾病国际研究中心（icddr,b）达卡医院，对15岁以下疑似肺结核的门诊患者进行了一项前瞻性诊断准确性研究。我们评估了RISK6检测方法的准确性，并进行了每例结核病病例识别成本分析。
在365名登记儿童中，68例经微生物学确诊为结核病，94例结核病未确诊，203例不太可能患有结核病。RISK6检测方法未达到儿童结核病诊断的TPP标准，但在≤12个月的疑似肺结核个体中，该检测方法在正确推荐个体进行确诊检测方面，表现优于结核菌素试验（7/42）和胸部X光检查（11/42）（32/42）。RISK6单独使用或与结核菌素试验联合使用，是识别和确诊结核病最具成本效益的策略，对于12个月以上儿童，成本低至132.00美元。
虽然RISK6检测方法未达到WHO结核病诊断的TPP标准，但它有望作为一种分流检测方法，特别是对于≤12个月的儿童，并且可以作为WHO推荐的综合治疗方案中的决策支持工具。
