University of New South Wales, Kogarah, NSW, Australia.
Department of Dermatology, St George Hospital, Sydney, NSW, Australia.
J Eur Acad Dermatol Venereol. 2019 Dec;33(12):2327-2333. doi: 10.1111/jdv.15817. Epub 2019 Aug 12.
The BIOCHIP (Dermatology Mosaic 7; EUROIMMUN, Lubeck, Germany) is a novel multiplex indirect immunofluorescence (IIF) technique used in the serological diagnosis of bullous pemphigoid (BP) and pemphigus.
To validate the accuracy and inter-rater reliability (IRR) of the BIOCHIP in the diagnosis of BP, pemphigus foliaceus (PF) and pemphigus vulgaris (PV).
Sera from patients with BP (n = 38), PF (n = 8), PV (n = 23), control patients (n = 64) and healthy control volunteers (n = 39) were tested. Sera were collected and analysed during the course of the disease at 1-5 different time points. The BIOCHIP was performed for all patients, digital images were captured of each incubated field, and the images were shared with 10 dermatologists experienced in reading IF from around the world to report. There were 312 BIOCHIP slides consisting of 1872 photos in total. All patients were de-identified. Fleiss Kappa was used to estimate the IRR.
Fleiss Kappa was computed for each category (Oesophagus, Oesophagus immunofluorescence pattern, Salt-Split Skin (SSS), SSS immunofluorescence location, BP180, BP230, Dsg 1 and Ds3). The inter-rater agreement between the 10 raters varied between fair and moderate for all categories. Those that demonstrated fair concordance included monkey oesophagus (k = 0.257, P < 0.0001), oesophagus pattern (k = 0.357, P < 0.0001), Dsg1 (k = 0.390, P < 0.0001) and BP230 (k = 0.281, P < 0.0001). Moderate agreement was demonstrated for SSS (k = 0.416, P < 0.0001), SSS immunofluorescence location (k = 0.505, P < 0.0001), Dsg3 (k = 0.437, P < 0.0001) and BP180 (k = 0.559, P < 0.0001).
The BIOCHIP mosaic-based immunofluorescence test is a simple, time and effort saving test that can aid in the diagnosis and screening of BP, PV and PF. However, the level of agreement was relatively low. The authors found the most common causes to be variable levels of training, indicating the presence of a learning curve in the interpretation of the results and ambiguous staining patterns leading to incongruent results.
BIOCHIP（Dermatology Mosaic 7；EUROIMMUN，吕贝克，德国）是一种新型的多重间接免疫荧光（IIF）技术，用于大疱性类天疱疮（BP）和天疱疮的血清学诊断。
验证 BIOCHIP 在 BP、落叶型天疱疮（PF）和寻常型天疱疮（PV）诊断中的准确性和组内一致性（IRR）。
检测了 38 例 BP、8 例 PF、23 例 PV、64 例对照患者和 39 名健康对照志愿者的血清。在疾病过程中，在 1-5 个不同时间点采集血清。对所有患者进行 BIOCHIP 检测，对每个孵育场的图像进行数字化捕获，并与来自世界各地的 10 位具有 IF 阅读经验的皮肤科医生共享以进行报告。共有 312 张 BIOCHIP 载玻片，共包含 1872 张照片。所有患者均进行去识别处理。采用 Fleiss Kappa 评估 IRR。
为每个类别（猴食管、猴食管免疫荧光模式、盐裂皮肤（SSS）、SSS 免疫荧光位置、BP180、BP230、Dsg1 和 Ds3）计算了 Fleiss Kappa。10 位评分者之间的组内一致性在所有类别中均为适度至良好。猴食管（k=0.257，P<0.0001）、食管模式（k=0.357，P<0.0001）、Dsg1（k=0.390，P<0.0001）和 BP230（k=0.281，P<0.0001）的一致性较好。SSS（k=0.416，P<0.0001）、SSS 免疫荧光位置（k=0.505，P<0.0001）、Dsg3（k=0.437，P<0.0001）和 BP180（k=0.559，P<0.0001）的一致性为中度。
BIOCHIP 马赛克免疫荧光检测是一种简单、省时省力的检测方法，可辅助 BP、PV 和 PF 的诊断和筛查。然而，一致性水平相对较低。作者发现最常见的原因是培训水平不同，表明在解释结果和不明确的染色模式方面存在学习曲线，导致结果不一致。
