Cincinnati Children’s Hospital Medical Center, Cincinnati, OH 45229, USA.
IEEE Trans Biomed Eng. 2011 Mar;58(3):837-40. doi: 10.1109/TBME.2010.2085003. Epub 2010 Oct 7.
Chlamydia trachomatis is a common sexually transmitted infection in young women. Available point-of-care (POC) diagnostic tests perform poorly, but development of new devices can be costly and time consuming. We explored the feasibility (user friendliness) and test characteristics (sensitivity and specificity) of a new prototype device to detect Chlamydia in adolescent women by using small numbers of subjects and rapid communication with the manufacturer. We compared cervical POC test results to the gold standard (cervical nucleic acid amplification testing). We also assessed the accuracy of the POC test on self-collected vaginal swabs by comparing results to cervical nucleic acid amplification test and to the cervical POC test. We frequently reviewed user experience and test results with the manufacturer. The results showed the feasibility and accuracy of the device. Feasibility--initial device malfunctions were identified and corrected. This device would be easy to use in a nonclinical setting, as it is self-contained and the color change for some specimens was dramatic and immediate. Accuracy--initial prototypes demonstrated low sensitivities (38%) for vaginal and cervical swabs. After feedback, the company developed new prototypes with improved sensitivity (80%). However, the increased sensitivity was accompanied by a high percentage of indeterminate results and false positives that lowered specificity.
沙眼衣原体是年轻女性中常见的性传播感染。现有的即时检测（POC）诊断测试效果不佳，但新设备的开发可能既昂贵又耗时。我们通过使用少量研究对象并与制造商进行快速沟通，探索了一种新的原型设备检测青少年女性沙眼衣原体的可行性（用户友好性）和测试特性（敏感性和特异性）。我们将宫颈 POC 检测结果与金标准（宫颈核酸扩增检测）进行了比较。我们还通过比较阴道拭子的 POC 检测结果与宫颈核酸扩增检测和宫颈 POC 检测结果，评估了该 POC 检测在自我采集阴道拭子上的准确性。我们经常与制造商一起审查用户体验和测试结果。结果表明该设备具有可行性和准确性。可行性——最初发现并纠正了设备故障。该设备易于在非临床环境中使用，因为它是独立的，并且某些标本的颜色变化明显且迅速。准确性——最初的原型对阴道和宫颈拭子的敏感性（38%）较低。在反馈后，该公司开发了具有更高敏感性（80%）的新原型。但是，敏感性的提高伴随着不确定结果和假阳性的比例增加，从而降低了特异性。
