Pike Joanna, Godbert Sonya, Johnson Sarah
SPD Development Co., Ltd , Priory Business Park, Bedford, MK44 3UP, UK.
Expert Opin Med Diagn. 2013 Sep;7(5):435-41. doi: 10.1517/17530059.2013.830103. Epub 2013 Aug 19.
Women suspecting pregnancy need an accurate result when they conduct a home pregnancy test. A variety of tests are available from simple professional style strips to midstream tests with a digitally displayed result. However, it is not known whether all these formats can be used and read correctly by untrained women.
The aim of this study is to evaluate usability and reading accuracy of home pregnancy test formats.
Female volunteers, 18 - 45 years (Manchester, UK) completed questionnaires on their home-use experience of six pregnancy tests (strip, cassette, midstream visual and digital formats). These volunteers then evaluated device results using hCG-urine standards at a study centre, thereafter completing a questionnaire and ranking evaluation.
Data were available from 111 volunteers. Women preferred midstream test formats; > 70% scored branded midstream digital and easy-use visual tests as 1or 2 (7-point Likert score), compared with ∼ 30% for store-brand and branded midstream visual tests, and < 10% for cassette or strip tests. Many cassette tests (23%) failed to provide a result (4, ≤ 2% for strips, midstream, respectively). Volunteers disagreed with study co-ordinator reading of test results in 30 and 40% of cases for the cassette and strip test results, respectively, compared with < 3% when using midstream digital or easy-use visual tests. Volunteers preferred the branded midstream digital, followed by branded midstream easy-use and visual tests.
In this study, the branded midstream digital test was superior to other tests evaluated and fulfilled the criteria of being an easy-to-use and interpret test; strip and cassette tests showed poor performance in women's hands.
怀疑自己怀孕的女性在进行家庭妊娠检测时需要准确的结果。从简单的专业试纸到能数字显示结果的尿杯检测,有多种检测方式可供选择。然而,尚不清楚所有这些检测形式未经培训的女性是否都能正确使用和读取。
本研究旨在评估家庭妊娠检测形式的易用性和读取准确性。
年龄在18 - 45岁的女性志愿者(英国曼彻斯特)完成了关于六种妊娠检测(试纸、尿杯、尿杯可视化和数字形式)家庭使用体验的问卷调查。然后这些志愿者在研究中心使用人绒毛膜促性腺激素尿液标准评估检测结果,之后完成一份问卷和等级评估。
有111名志愿者的数据可供分析。女性更喜欢尿杯检测形式;超过70%的人将品牌尿杯数字检测和易用的可视化检测评为1或2(7分制李克特量表评分),相比之下,商店品牌和品牌尿杯可视化检测的这一比例约为30%,而尿杯或试纸检测的这一比例小于10%。许多尿杯检测(23%)未能给出结果(试纸和尿杯检测分别为4%和≤2%)。对于尿杯和试纸检测结果,志愿者分别在30%和40%的情况下不同意研究协调员对检测结果的判读,而使用尿杯数字或易用可视化检测时这一比例小于3%。志愿者更喜欢品牌尿杯数字检测,其次是品牌尿杯易用和可视化检测。
在本研究中,品牌尿杯数字检测优于其他评估的检测,并符合易于使用和解读的标准;试纸和尿杯检测在女性使用时表现不佳。