Delphi result.

BackgroundEffective regulation and control of tobacco products require robust laboratory testing capabilities to ensure quality, safety and compliance with relevant standards. Currently, no standardized assessment tool exists globally to evaluate the tobacco testing laboratories. This study aims to address this gap by developing the Tobacco Testing Laboratory Assessment Tool (TTLAT). This tool aligns with the WHO-FCTC on Tobacco Control’s Article 9, which calls for the adoption and implementation of effective testing, measuring, and regulation measures.MethodologyThe TTLAT was developed through a systematic literature review and a two-round Delphi technique involving 24 experts. The tool was then validated in four National Tobacco Testing Laboratories in India. Content validity was assessed using the Item-Content Validity Index (I-CVI) and Scale-Content Validity Index (S-CVI). Construct validity was evaluated through exploratory and confirmatory factor analyses. Internal consistency reliability was measured using Cronbach’s alpha.ResultsThe final TTLAT comprises 213 items across 11 critical domains including General Information (17), Documents (37), Organization and Management (10), Human Resources (28), Infrastructure (7), Equipment (23), Consumables and Reagents (10), Sample Handling (17), Tobacco Product Analytes (8), Data Management (36), and Biosafety and Biosecurity (20). Content validity analysis showed excellent results. Exploratory factor analysis identified six factors accounting for 52.5% of the total variance. Confirmatory factor analysis demonstrated good model fit (CFI = 0.91; TLI = 0.90; RMSEA = 0.05; SRMR = 0.06). The tool showed high internal consistency reliability across factors (Cronbach’s alpha 0.72–0.92).ConclusionThe TTLAT demonstrates strong psychometric properties and provides a comprehensive, standardised approach for assessing tobacco testing laboratory capacity.背景 对烟草产品实施有效监管需依托坚实的实验室检测能力，以保障产品质量、安全及相关标准合规性。目前全球尚无标准化评估工具用于烟草检测实验室的能力评价。本研究旨在填补这一空白，开发烟草检测实验室评估工具（Tobacco Testing Laboratory Assessment Tool，TTLAT）。该工具契合《世界卫生组织烟草控制框架公约》（WHO-FCTC）第9条要求，该条款呼吁采用并实施有效的检测、计量与监管措施。 方法 本研究通过系统文献综述及两轮德尔菲（Delphi）专家咨询法开发TTLAT，共纳入24名专家。随后在印度4家国家烟草检测实验室对该工具开展验证工作。采用条目内容效度指数（Item-Content Validity Index，I-CVI）与量表内容效度指数（Scale-Content Validity Index，S-CVI）评估内容效度；通过探索性因子分析与验证性因子分析评价结构效度；采用克朗巴赫α系数（Cronbach’s alpha）测量内部一致性信度。 结果 最终版TTLAT涵盖11个关键领域共213个条目，具体包括：基本信息（17项）、文件资料（37项）、组织与管理（10项）、人力资源（28项）、基础设施（7项）、仪器设备（23项）、耗材与试剂（10项）、样品处理（17项）、烟草产品分析物（8项）、数据管理（36项）及生物安全与生物安保（20项）。内容效度分析结果优异。探索性因子分析共提取6个公因子，累计解释总方差的52.5%。验证性因子分析显示模型拟合度良好（CFI=0.91；TLI=0.90；RMSEA=0.05；SRMR=0.06）。各公因子的内部一致性信度较高，克朗巴赫α系数介于0.72~0.92之间。 结论 TTLAT具备优异的心理测量学属性，可为烟草检测实验室的能力评估提供一套全面且标准化的方案。