Gynaecology Clinic, Charité Universitätsmedizin, Corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Hindenburgdamm 30, 12200, Berlin, Germany.
AID/GenID Diagnostika, Ebinger Strasse 4, 72479, Strassberg, Germany.
Virol J. 2019 Jul 23;16(1):92. doi: 10.1186/s12985-019-1197-6.
HPV DNA Array is an E1-targeting PCR genotyping test, with capability of distinguishing 18 high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) and 11 low-risk HPV types (6, 11, 40, 42, 44, 54, 67, 69, 70, 85, 97). HPV DNA Array uses multiplex PCR for E1-gene sequence amplification. The amplicons are detected and genotyped by reverse hybridization to immobilized DNA probes spotted as triplets in single 96 well-plate wells and read by AID ELISPOT reader.
Aim of the study was to evaluate the clinical performance of the assay against internationally accepted and FDA approved Cobas 4800 HPV test (Roche Diagnostics). Study population comprised of 500 cervical samples.
HPV DNA Array demonstrated a very high sensitivity of 100% for CIN2+ and 100% for CIN3+ detection, same as Cobas 4800. HPV DNA Array showed greater sensitivity for CIN2+ detection than cytology (100% vs. 13.6%). The agreement to Cobas 4800 for HPV detection, irrespective of type, was 81.4% with κ = 0.613. The agreement for HPV 16 was 92.8% (κ = 0.929), and for HPV 18 54.2% (κ = 0.681).
HPV DNA Array demonstrated good clinical performance for detection of high-grade lesions, and may be considered for usage in a screening setting.
HPV DNA 芯片是一种针对 E1 靶向的 PCR 基因分型检测，能够区分 18 种高危型（16、18、26、31、33、35、39、45、51、52、53、56、58、59、66、68、73、82）和 11 种低危型 HPV（6、11、40、42、44、54、67、69、70、85、97）。HPV DNA 芯片采用多重 PCR 对 E1 基因序列进行扩增。扩增产物通过反向杂交固定在 DNA 探针上进行检测和基因分型，这些探针以三联体的形式点样于单个 96 孔板的孔中，并通过 AID ELISPOT 读取器进行读取。
本研究旨在评估该检测方法与国际公认和 FDA 批准的 Cobas 4800 HPV 检测（罗氏诊断）相比的临床性能。研究人群包括 500 例宫颈样本。
HPV DNA 芯片对 CIN2+和 CIN3+的检测灵敏度均为 100%，与 Cobas 4800 相同。HPV DNA 芯片对 CIN2+的检测灵敏度高于细胞学（100% vs. 13.6%）。HPV 检测与 Cobas 4800 的一致性，无论 HPV 类型如何，均为 81.4%，κ 值为 0.613。HPV 16 的一致性为 92.8%（κ 值为 0.929），HPV 18 的一致性为 54.2%（κ 值为 0.681）。
HPV DNA 芯片在检测高级别病变方面具有良好的临床性能，可考虑用于筛查。
