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在试管式、微孔式和斑点式的酶免测定法测定人绒毛膜促性腺激素（ＨＣＧ）的基础上，发展了应用双单克隆抗体的免疫层析一步法测定ＨＣＧ。此法用胶体金标记抗βＨＣＧ单克隆抗体，将抗αＨＣＧ单克隆抗体包被在硝酸纤维素膜上。无需分离步骤，特别是在进行测定时除加入样品外无需再加任何试剂，此方法特别迅速、简便，２～５ｍｉｎ即可得结果。凡ＨＣＧ浓度＞２５ＩＵ／Ｌ的样品可得到阳性结果。在人体血或尿中可能出现的高浓度的干扰物质，如抗坏血酸、乙酰水杨酸、雌二醇、蛋白质、胆红素、甘油三酯等对本测定均无干扰作用，在促黄体激素（ＬＨ）浓度高达５００ＩＵ／Ｌ时仍与ＨＣＧ没有交叉反应。能进行测定的最高值大于３００ＩＵ／ｍｌ，这表示，当ＨＣＧ浓度达到妊娠期的最高值时仍不会有假阴性结果。
Based on the assay of human chorionic gonadotropin (HCG) by in vitro test, micropore and spot enzyme immunoassay, one-step immunochromatographic assay for the determination of HCG using dual monoclonal antibodies was developed. This method uses colloidal gold labeled anti-βHCG monoclonal antibody, anti-αHCG monoclonal antibody coated on the nitrocellulose membrane. No need to separate step, especially in the determination of addition to the sample without adding any reagents, this method is particularly fast and easy, 2 ~ 5min to get results. Samples with HCG concentrations> 25 IU / L yielded positive results. High concentrations of interfering substances, such as ascorbic acid, acetylsalicylic acid, estradiol, protein, bilirubin and triglyceride, which may appear in human blood or urine, have no interfering effect on this assay. In the presence of luteinizing hormone ) Did not cross-react with HCG at concentrations up to 500 IU / L. The highest value that can be determined is greater than 300 IU / ml, indicating that there is still no false-negative result when the HCG concentration reaches the highest value of pregnancy.