Vyberg Mogens, Nielsen Søren, Røge Rasmus, Sheppard Beth, Ranger-Moore Jim, Walk Eric, Gartemann Juliane, Rohr Ulrich-Peter, Teichgräber Volker
NordiQC, Institute of Pathology, Aalborg University Hospital, Ladegaardsgade 3, DK-9000, Aalborg, Denmark.
Ventana Medical Systems Inc, 1910 E Innovation Park Drive, Tucson, AZ, 85755, USA.
BMC Health Serv Res. 2015 Aug 29;15:352. doi: 10.1186/s12913-015-1018-6.
Treatment for patients with breast cancer (BC) is guided by human epidermal growth factor receptor 2 (HER2) status. The patient's HER2 status is assessed using US Food and Drug Administration-approved in vitro diagnostic (IVD) immunohistochemical (IHC) tests and laboratory-developed IVD tests. We analysed HER2 testing accuracy using data from the Nordic Immunohistochemistry Quality Control (NordiQC) HER2 IHC programme; results were used in an economic BC treatment model.
Data were obtained from NordiQC HER2 BC surveys performed from 2008 to 2012. False-negative (FN) and false-positive (FP) rates for approved and laboratory-developed IVDs were used to estimate direct costs, loss of survival, productivity benefit and quality-adjusted life-years. In the absence of consistent and accessible clinical and economic data from countries participating in the NordiQC programme, United States productivity data, healthcare costs and patient numbers were used as a surrogate in order to estimate the potential impact of selecting an approved or laboratory-developed IVDs.
In total, 1703 tests were performed. Pooled FN rates were 11% for approved IVDs and 25% for laboratory-developed IVDs; FP rates were 0% and 5%, respectively. Using these FP and FN rates in the economic model and applying them to the United States BC population, approved IVD tests would result in better clinical outcomes, i.e., better survival and fewer disease recurrences/progressions, and lower costs, i.e., total direct costs and lost productivity, versus laboratory-developed IVD tests. Every $1 saved by laboratories by using cheaper reagents could potentially result in approximately $6 additional costs to the healthcare system.
The results of this analysis suggest that incorrect HER2 test results have far-reaching clinical and economic consequences.
乳腺癌（BC）患者的治疗以人表皮生长因子受体2（HER2）状态为指导。患者的HER2状态通过美国食品药品监督管理局批准的体外诊断（IVD）免疫组织化学（IHC）检测和实验室研发的IVD检测来评估。我们使用北欧免疫组织化学质量控制（NordiQC）HER2 IHC项目的数据分析了HER2检测的准确性；结果被用于乳腺癌治疗经济模型。
数据来自2008年至2012年进行的NordiQC HER2乳腺癌调查。批准的和实验室研发的IVD的假阴性（FN）率和假阳性（FP）率用于估计直接成本、生存损失、生产力效益和质量调整生命年。由于参与NordiQC项目的国家缺乏一致且可获取的临床和经济数据，因此使用美国的生产力数据、医疗成本和患者数量作为替代，以估计选择批准的或实验室研发的IVD的潜在影响。
总共进行了1703次检测。批准的IVD的合并FN率为11%，实验室研发的IVD的合并FN率为25%；FP率分别为0%和5%。在经济模型中使用这些FP和FN率并将其应用于美国乳腺癌人群，与实验室研发的IVD检测相比，批准的IVD检测将产生更好的临床结果，即更好的生存率和更少的疾病复发/进展，以及更低的成本，即总直接成本和生产力损失。实验室通过使用更便宜的试剂每节省1美元，可能会给医疗系统带来约6美元的额外成本。
该分析结果表明，HER2检测结果错误会产生深远的临床和经济后果。
