Asch R H, Asch B, Asch G, Asch M, Bray R, Rojas F J
Department of Obstetrics and Gynecology, University of California, Irvine, Orange.
Int J Fertil. 1988 May-Jun;33(3):154, 157-8, 161.
We have studied the performance of three currently available home pregnancy tests. The Advance is a test based on monoclonal antibodies in an enzyme immunoassay format that specifically detects hCG in urine. The positive results are determined by the presence of a blue color in a color stick (30 minutes). The Daisy 2 and FACT are tests based on monoclonal antibodies that specifically detect hCG in urine in a hemagglutination inhibition assay; positive results are demonstrated by the deposition of a dot ring at the bottom of the test tube (45 minutes). Thirty-five patients who eventually became pregnant in that cycle collected the first morning urine specimens from day of ovulation (determined by ultrasound) in artificial insemination donor (AID) cycles, or from the date of gamete intrafallopian transfer (GIFT) for 16 consecutive days. In each specimen, the Advance, Daisy 2, and FACT tests were performed; in addition, beta-hCG levels were determined by radioimmunoassay. All the home pregnancy tests studied can detect pregnancy as early as 9 or 10 days post-conception, and they give positive results at the time of the expected onset of menses in 70%, 95%, and 88% of cases for Daisy 2, Advance, and FACT, respectively. The sensitivity of the these home pregnancy tests was determined to be about 200 mIU/mL of urine after correlating their positive or negative results with the concentrations of urinary beta-hCG determined by radioimmunoassay.
我们研究了三种目前市面上可买到的家用妊娠试验的性能。Advance是一种基于酶免疫测定法的单克隆抗体检测，专门检测尿液中的人绒毛膜促性腺激素（hCG）。阳性结果通过显色棒中出现蓝色来判定（30分钟）。Daisy 2和FACT是基于单克隆抗体的检测，在血凝抑制试验中专门检测尿液中的hCG；阳性结果通过试管底部出现点状环来证明（45分钟）。35名在该周期最终怀孕的患者，在人工授精供体（AID）周期中从排卵日（通过超声确定）开始收集晨尿样本，或在配子输卵管内移植（GIFT）日期开始连续16天收集晨尿样本。对每个样本都进行了Advance、Daisy 2和FACT检测；此外，通过放射免疫测定法测定β-hCG水平。所研究的所有家用妊娠试验最早可在受孕后9或10天检测到怀孕，在预期月经来潮时，Daisy 2、Advance和FACT检测呈阳性的病例分别占70%、95%和88%。将这些家用妊娠试验的阳性或阴性结果与通过放射免疫测定法测定的尿液β-hCG浓度进行关联后，确定这些家用妊娠试验的灵敏度约为每毫升尿液200毫国际单位。
