Current Practices When Reporting Quantitative Human Chorionic Gonadotropin Test Results. 2020

David G Grenache
TriCore Reference Laboratories, Albuquerque, NM.

Quantitative human chorionic gonadotropin (hCG) tests are commonly used to determine a woman's pregnancy status. Discrete results are evaluated and/or interpreted against a reference interval or cutoff. Reporting practices across laboratories have not been investigated. A voluntary questionnaire was distributed to 6433 laboratories participating in a general chemistry proficiency testing survey. Responses were received from 3568 (55%) laboratories. Overall, 31% used a single reference cutoff, with 42% and 14% using values of 5.0 and 25.0 IU/L, respectively. In total, 68% of laboratories provided result interpretations, most frequently "negative" and "positive." Reference intervals based on chronological age were offered by 9% of laboratories; 60% reported gestational age-based intervals. In addition, 25% provided male-specific reference intervals, with 2.0 IU/L being the most commonly used single-point cutoff. Only 12% of laboratories offered a separate, orderable test for hCG as a tumor marker, with 5.0 IU/L as the most frequently used reference threshold. Nearly half of laboratories used assay product insert data as the reference interval source. There is wide variation when reporting quantitative hCG results. Despite a well-established reference limit of <5.0 IU/L for nonpregnant women, fewer than half of laboratories used this cutoff. The reporting of gestational age-based reference intervals is more common than those based on chronological age despite greater clinical utility for the latter. Data-driven guidelines for reporting quantitative hCG test results could deliver more consistent result interpretation.

UI MeSH Term Description Entries
D008297 Male Males
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D011258 Pregnancy Tests Tests to determine whether or not an individual is pregnant. Pregnancy Test,Test, Pregnancy,Tests, Pregnancy
D012016 Reference Values The range or frequency distribution of a measurement in a population (of organisms, organs or things) that has not been selected for the presence of disease or abnormality. Normal Range,Normal Values,Reference Ranges,Normal Ranges,Normal Value,Range, Normal,Range, Reference,Ranges, Normal,Ranges, Reference,Reference Range,Reference Value,Value, Normal,Value, Reference,Values, Normal,Values, Reference
D005260 Female Females
D006063 Chorionic Gonadotropin A gonadotropic glycoprotein hormone produced primarily by the PLACENTA. Similar to the pituitary LUTEINIZING HORMONE in structure and function, chorionic gonadotropin is involved in maintaining the CORPUS LUTEUM during pregnancy. CG consists of two noncovalently linked subunits, alpha and beta. Within a species, the alpha subunit is virtually identical to the alpha subunits of the three pituitary glycoprotein hormones (TSH, LH, and FSH), but the beta subunit is unique and confers its biological specificity (CHORIONIC GONADOTROPIN, BETA SUBUNIT, HUMAN). Chorionic Gonadotropin, Human,HCG (Human Chorionic Gonadotropin),Biogonadil,Choriogonadotropin,Choriogonin,Chorulon,Gonabion,Human Chorionic Gonadotropin,Pregnyl,Gonadotropin, Chorionic,Gonadotropin, Human Chorionic
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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