AdenoPlus 试验诊断腺病毒结膜炎的敏感性和特异性。

Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis.

机构信息

Manatee Sarasota Eye Clinic and Laser Center, Sarasota, Bradenton, FL 34202, USA.

出版信息

JAMA Ophthalmol. 2013 Jan;131(1):17-22. doi: 10.1001/2013.jamaophthalmol.513.

DOI:10.1001/2013.jamaophthalmol.513

PMID:23307204

Abstract

OBJECTIVE

To compare the clinical sensitivity and specificity of the AdenoPlus test with those of both viral cell culture (CC) with confirmatory immunofluorescence assay (IFA) and polymerase chain reaction (PCR) at detecting the presence of adenovirus in tear fluid.

METHODS

A prospective, sequential, masked, multicenter clinical trial enrolled 128 patients presenting with a clinical diagnosis of acute viral conjunctivitis from a combination of 8 private ophthalmology practices and academic centers. Patients were tested with AdenoPlus, CC-IFA, and PCR to detect the presence of adenovirus.

MAIN OUTCOME MEASURES

The sensitivity and specificity of AdenoPlus were assessed for identifying cases of adenoviral conjunctivitis.

RESULTS

Of the 128 patients enrolled, 36 patients' results were found to be positive by either CC-IFA or PCR and 29 patients' results were found to be positive by both CC-IFA and PCR. When compared only with CC-IFA, AdenoPlus showed a sensitivity of 90% (28/31) and specificity of 96% (93/97). When compared only with PCR, AdenoPlus showed a sensitivity of 85% (29/34) and specificity of 98% (89/91). When compared with both CC-IFA and PCR, AdenoPlus showed a sensitivity of 93% (27/29) and specificity of 98% (88/90). When compared with PCR, CC-IFA showed a sensitivity of 85% (29/34) and specificity of 99% (90/91).

CONCLUSION

AdenoPlus is sensitive and specific at detecting adenoviral conjunctivitis.

APPLICATION TO CLINICAL PRACTICE

An accurate and rapid in-office test can prevent the misdiagnosis of adenoviral conjunctivitis that leads to the spread of disease, unnecessary antibiotic use, and increased health care costs. Additionally, AdenoPlus may help a clinician make a more informed treatment decision regarding the use of novel therapeutics.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00921895.

摘要

目的

比较 AdenoPlus 试验与病毒细胞培养（CC）联合免疫荧光分析（IFA）和聚合酶链反应（PCR）检测眼部分泌物中腺病毒的临床敏感性和特异性。

方法

一项前瞻性、连续、盲法、多中心临床试验招募了 128 名来自 8 家私立眼科诊所和学术中心的临床诊断为急性病毒性结膜炎的患者。患者接受 AdenoPlus、CC-IFA 和 PCR 检测以检测腺病毒的存在。

主要观察指标

评估 AdenoPlus 用于确定腺病毒性结膜炎病例的敏感性和特异性。

结果

在纳入的 128 名患者中，36 名患者的 CC-IFA 或 PCR 检测结果阳性，29 名患者的 CC-IFA 和 PCR 检测结果均阳性。仅与 CC-IFA 比较时，AdenoPlus 的敏感性为 90%（28/31），特异性为 96%（93/97）。仅与 PCR 比较时，AdenoPlus 的敏感性为 85%（29/34），特异性为 98%（89/91）。与 CC-IFA 和 PCR 比较时，AdenoPlus 的敏感性为 93%（27/29），特异性为 98%（88/90）。与 PCR 比较时，CC-IFA 的敏感性为 85%（29/34），特异性为 99%（90/91）。