An evaluation of four serum tests for pregnancy.

We evaluated four pregnancy tests (Biocept-G, Beta-CG, Preg/Stat, and HCG-Beta Screen), using sera from 59 nonpregnant subjects and 77 patients with serum human choriogonadotropin beta-subunit (beta-hCG) concentrations ranging from 4 to 100 000 int. units/L. The results obtained for each test were compared with the results predicted on the basis of the sample's beta-hCG concentration and the beta-hCG concentration the manufacturer claimed necessary for a positive result (the test's analytical sensitivity). Biocept-G had the best sensitivity (100%), specificity (98.9%), and accuracy (99.2%). Beta-CG had the poorest sensitivity (86.4%), Preg/Stat the poorest specificity (87.5%), and accuracy (92.6%). We confirmed the manufacturer's claimed analytical sensitivity (200 int. units/L) for the Biocept-G procedure, but our calculated analytical sensitivity for the other tests was significantly different from that claimed by their manufacturers. Best results were obtained with Biocept-G, but with its analytical sensitivity of 200 int. units/L, samples from early pregnancy will give negative results. None of the pregnancy tests evaluated here will establish the presence or absence of early pregnancy with certainty.

[1]  M. Miodovnik,et al.  Human chorionic gonadotropin (beta-subunit) in the early diagnosis of ectopic pregnancy. , 1978, Obstetrics and gynecology.

[2]  F. C. Greiss,et al.  Maternal deaths from ectopic pregnancy in the South Atlantic region, 1960 through 1976. , 1978, American journal of obstetrics and gynecology.

[3]  A. Decherney,et al.  Contemporary management of ectopic pregnancy. , 1981, The Journal of reproductive medicine.

[4]  T. Cole,et al.  Chronic Ectopic Pregnancy , 1982, Obstetrics and gynecology.

[5]  Schwartz Ro,et al.  beta-hCG as a diagnostic aid for suspected ectopic pregnancy. , 1980 .

[6]  B. Saxena,et al.  The use of a radioreceptorassay of human chorionic gonadotropin for the diagnosis and management of ectopic pregnancy. , 1975, Fertility and sterility.

[7]  Braunstein Gd,et al.  A rapid modification of the beta-hCG radioimmunoassay. Use as an aid in the diagnosis of ectopic pregnancy. , 1977 .

[8]  B. Saxena,et al.  Diagnosis and management of pregnancy by the radioreceptorassay of human chorionic gonadotropin. , 1978, American journal of obstetrics and gynecology.

[9]  B. Saxena,et al.  Results of the First 1000 Radioreceptorassays for the Determination of Human Chorionic Gonadotropin: A New, Rapid, Reliable, and Sensitive Pregnancy Test *† , 1976 .

[10]  J. Schneider,et al.  Maternal Mortality Due to Ectopic Pregnancy: A Review of 102 Deaths , 1977, Obstetrics and gynecology.

[11]  M. Oermann,et al.  [Clinical evaluation]. , 1981, Ugeskrift for laeger.

[12]  E. Jawetz,et al.  A clinical evaluation , 1961 .

[13]  D. Goldstein,et al.  Use of a Radioimmunoassay Specific for Human Chorionic Gonadotropin in the Diagnosis of Early Ectopic Pregnancy , 1973, Obstetrics and gynecology.

[14]  J. Thompson,et al.  The radioreceptor assay for hCG in ectopic pregnancy. , 1979, Obstetrics and gynecology.