Prospective assessment of early fetal loss using an immunoenzymometric screening assay for detection of urinary human chorionic gonadotropin.
OBJECTIVE
To develop an economical, nonradiometric immunoenzymometric assay (IEMA) for the detection of urinary human chorionic gonadotropin (hCG) in studies of early fetal loss. To be effective, the IEMA must have a sensitivity equal to the standard immunoradiometric assay (IRMA) and sufficient specificity to eliminate the need for screening most nonconceptive cycles with the expensive and labor-intensive IRMA.


METHODS
Two different assays were used to measure hCG in daily early morning urine samples from potential conceptive cycles.


METHODS
Women undergoing donor artificial insemination (AI) were evaluated in a prospective study.


METHODS
Ninety-two women volunteers were selected on the basis of apparent normal reproductive health.


METHODS
Artificial insemination with nonfrozen donor semen was performed by cervical cup twice each menstrual cycle at 48-hour intervals, and daily urine samples were self-collected throughout the menstrual cycle.


METHODS
An IEMA was developed to detect urinary hCG using the same antibodies as in the standard IRMA; a study was designed to determine whether this nonradiometric assay could successfully detect the early fetal loss that was detected by the IRMA.


RESULTS
Of 224 menstrual cycles analyzed by both assays, a total of six early fetal losses were detected by the IRMA. When the tentative screening rule was set to allow all six of these losses and 95% of future losses to be detected by the IEMA, an additional 34 false-positive results were detected by the IEMA. The specificity of the IEMA with this rule was calculated to be 84%.


CONCLUSIONS
An IEMA based on the same antibodies used for the standard IRMA can serve as an efficient screening assay for the detection of early fetal loss. When the IEMA is used in this manner, nearly 80% of screened menstrual cycles can be eliminated without further testing by the IRMA.
Taylor
C A
CA
University of California, Davis.
Overstreet
J W
JW
Samuels
S J
SJ
Boyers
S P
SP
Canfield
R E
RE
O'Connor
J F
JF
Hanson
F W
FW
Lasley
B L
BL
D000022:Abortion, Spontaneous / Q000175:diagnosis* / Q000652:urine; D006063:Chorionic Gonadotropin / Q000652:urine*; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques; D015592:Immunoradiometric Assay; D011247:Pregnancy; D011446:Prospective Studies; D012680:Sensitivity and Specificity
D006063:Chorionic Gonadotropin