2026 ACOG临床共识：非妊娠无妇科恶性肿瘤患者人绒毛膜促性腺激素试验阳性的管理（No.11）

SUMMARY

Positive human chorionic gonadotropin (hCG) test results have been associated with unnecessary workup and treatment, including invasive procedures and chemotherapy. It is important for healthcare professionals to consider alternative explanations for positive hCG results when pregnancy and malignancy have been excluded, particularly before proceeding with more invasive interventions. Due to the multiple potential etiologies of persistently elevated hCG, health care professionals should evaluate test results according to a systematic framework. When serum hCG test results are elevated, the first steps are to evaluate for pregnancy (both intrauterine and ectopic). Appropriate retesting to rule out various etiologies and to identify the main cause of persistently elevated hCG is necessary to avoid misdiagnosis or mismanagement of elevated hCG levels.

BACKGROUND

The human chorionic gonadotropin (hCG) test is an assay using serum or urine that is commonly used in the management and detection of early pregnancy and gynecologic conditions, including gestational trophoblastic disease and gonadal germ cell malignancies. In these conditions, positive test results may lead to further testing or interventions. In certain clinical scenarios, a positive hCG test result may represent a false-positive (eg, testing failure) or may

be due to other diagnoses unrelated to pregnancy or gynecologic neoplasms.

Positive hCG test results have been associated with unnecessary workup and treatment, including invasive procedures and chemotherapy. It is important for health care professionals to consider alternative explanations for positive hCG results when pregnancy and malignancy have been excluded, particularly before proceeding with more invasive interventions. This Clinical Consensus statement summarizes the various causes

The American College of Obstetricians & Gynecologists (ACOG) reviews its publications regularly; however, its publications may not reflect the most recent evidence. A reaffirmation date is included in the online version of a document to indicate when it was last reviewed. The current status and any updates of this document can be found on ACG Clinical at acog.org/lot.

This information is designed as an educational resource to aid clinicians in providing obstetric and gynecologic care, and use of this information is voluntary. This information should not be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. It is not intended to substitute for the independent professional judgment of the treating clinician. Variations in practice may be warranted when, in the reasonable judgment of the treating clinician, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology.

While ACOG makes every effort to present accurate and reliable information, this publication is provided "as is" without any warranty of accuracy, reliability, or otherwise, either express or implied. ACOG does not guarantee, warrant, or endorse the products or services of any firm, organization, or person. Neither ACOG nor its officers, directors, members, employees, or agents will be liable for any loss, damage, or claim with respect to any liabilities, including direct, special, indirect, or consequential damages, incurred in connection with this publication or reliance on the information presented.

of elevated hCG levels at the point where pregnancy and gynecologic malignancy have been excluded for the patient. This Clinical Consensus also provides health care professionals with an algorithm to guide the management of persistently elevated hCG levels. Diagnosis and management of gestational trophoblastic disease and pregnancy were deemed out of scope for this document; however, health care professionals may consult the Society of Gynecologic Oncology's recommendation on the Epidemiology, Diagnosis, and Treatment of Gestational Trophoblastic Disease and ACOG Practice Bulletin 193, Tubal Ectopic Pregnancy, respectively, for additional guidance. Although false-positive and elevated hCG levels can occur in male populations, this document focuses primarily on individuals assigned female at birth.

DEFINITION

Positive hCG

Human chorionic gonadotropin is a heterodimeric glycoprotein produced by trophoblastic tissue and is comprised of two subunits: alpha and beta. The alpha unit is nearly identical to the alpha subunits of pituitary luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid-stimulating hormone. The beta subunit of hCG is highly homologous with the beta subunit of LH, but it is distinguished by a unique C-terminal peptide.

Although often referred to generically, multiple hCG forms exist, with similar but not identical structures. Two forms (hCG and hyperglycosylated hCG) play a critical role in pregnancy, and another form (sulfated hCG) is produced by the pituitary gland (1). Hyperglycosylated hCG is produced in pregnancy by placental trophoblasts and is associated with implantation.

Most commercial serum and urine hCG assays are enzyme-linked immunosorbent assays, or "sandwich assays." Two antibodies, a monoclonal antibody targeted to a specific region of the beta unit of hCG and an antibody that is labeled with a tracer, bind and trap the hCG molecule. These assays can provide a qualitative (positive or negative) or quantitative result (Fig. 1).

Both urine and serum hCG tests can be qualitative; however, serum hCG tests can more specifically quantitate hCG levels. Qualitative tests are used clinically to determine the presence or absence of pregnancy, often with a rapid diagnosis; quantitative tests are used in evaluation and management of early pregnancy as well as in determining the need and the success of treatment for malignancies.

Generally, the reference range cutoff for serum hCG is less than 5 international units/L in premenopausal non-pregnant individuals. There may be variation in laboratory reporting, with some facilities including chronic age reference cutoffs (2). The prevalence of positive hCG

 Fig. 1. "Sandwich" assay in commercial testing for human chorionic gonadotropin (hCG). A schematic illustration of the "sandwich" principle in commercial hCG assays (left). A capture antibody is fixed in a solid phase and immobiliizes hCG by binding to one or more hCG subunit antigens. One or both of these subunits are then bound at a distant site by a tracer antibody. The amount of detected tracer is proportional to the amount of hCG. Heterophile antibodies (right) bind both capture and tracer antibodies in the absence of hCG causing a false-positive assay result. Reprinted with permission from Oyatogun O, Sandhu M, Barata-Kirby S, Tuller E, Schust DJ. A rational diagnostic approach to the "phantom hCG" and other clinical scenarios in which a patient is thought to be pregnant but is not. Ther Adv Reprod Health 2021;15:1–13. Copyright 2021 by Sage Publications. doi: 10.1177/26334941211016412.

Management of Positive Human Chorionic Gonadotropin Test. Obstet Gynecol 2026.

results using a cutoff of more than 5 international units/L in postmenopausal individuals aged 55 years or older is as high as 8% (3), because pituitary hCG production increases with low levels of estradiol. As a result, the hCG cutoff for that age group has been recommended to be 14 international units/L. Therefore, hCG levels should be interpreted with FSH levels in perimenopausal and menopausal individuals (4).

Urine pregnancy tests may detect a serum hCG level greater than 25 international units/L, although some variability may exist depending on urine concentration and specific gravity. Clinicians should check the specific requirements of the laboratory test ordered.

False-Positive hCG

The term “false-positive hCG” is sometimes used to describe an hCG level that is detectable outside of pregnancy, gestational trophoblastic disease, or malignant germ cell tumor. In fact, the detection of hCG is often not false but rather is explained by an alternative diagnosis. An hCG result that is positive due to assay interference, such as heterophilic antibodies, in the absence of circulating hCG is estimated to occur in 1 in 1,000 to 1

in 10,000 serum tests (5). Interference due to cross-reactive antibodies also has been referred to as “phantom hCG” (6). For the purposes of this document, “false-positive” hCG will refer only to results caused by assay interference.

True-Positive hCG

In this document, true-positive hCG will refer to other causes of elevated hCG that do not occur as a result of assay interference. The presence of hCG as a tumor marker in gestational trophoblastic disease and malignant germ cell tumors is well recognized. Outside these gynecologic settings, an elevated hCG level has been described in other clinical conditions, including non-gynecologic malignancies, pituitary source, and familial hCG syndrome.

METHODS

This Clinical Consensus document was developed using an a priori protocol in conjunction with the authors listed above. The a priori protocol was modeled after the Clinical Consensus methodology; a full description of the Clinical Consensus methodology has been published separately (https://www.acog.org/clinical/clinical-guidance/clinical-consensus/articles/1021/09/clinical-consensus-methodology). The description below is specific to this Clinical Consensus document.

Literature Search

A literature search was performed from 2000 to February 2024 for clinical questions as noted in the outline. American College of Obstetricians & Gynecologists' medical librarians searched Medline through Ovid and PubMed for human-only studies written in English. MeSH terms and keywords can be found in Appendix 1 (available online at http://links.lww.com/AOG/E455). Search terms for racial and ethnic disparities in management of positive hCG test results in nonpregnant patients were incorporated into the literature review, and recommendations were drafted with the intent to promote health equity and reduce these disparities. A bridge literature search was completed in March 2025. Any updated literature was incorporated into the text and recommendations, as appropriate.

Study Selection

Qualifying studies passed both title and abstract screen and full-text screen and met the following inclusion criteria: conducted in countries ranked very high on the United Nations Human Development Index (7), included female participants, and included all study designs. Studies that passed full-text screen by the authors were included in a summary evidence map (Appendix 2, available online at http://links.lww.com/AOG/E456).

SUMMARY OF CONSENSUS RECOMMENDATIONS

Health care professionals should have an understanding of the various etiologies for elevated hCG levels in nonpregnant individuals without gynecologic malignancy.

Health care professionals should follow a systematic approach to retesting and evaluating test results that considers patient history, outcomes from previous tests and assays, and patient risk for other underlying causes of a positive hCG test result.

Health care professionals should be aware of alternative retesting methods to identify heterophilic antibodies that would result in false-positive hCG test results.

hCG, human chorionic gonadotropin.

Consensus Voting and Recommendation Development

At a meeting of the Committee on Clinical Consensus-Gynecology, a quorum of two-thirds of eligible voting members was met, and the committee held a formal vote for each proposed recommendation. All recommendation statements met or exceeded the 75% approval threshold required for consensus.

Causes of Persistently Elevated hCG

Health care professionals should have an understanding of the various etiologies for elevated hCG levels in nonpregnant individuals without gynecologic malignancy.

Human chorionic gonadotropin testing is well known for its use as a marker for gynecologic malignancy, including gestational trophoblastic neoplasia. Persistent low levels of serum hCG also have been reported in patients with quiescent gestational trophoblastic disease (8). The use of hCG in this setting is outside the scope of this document.

Persistently elevated hCG levels in nonpregnant individuals without gynecologic malignancy can result from a variety of etiologies. Several of these causes are listed in Box 1.

Heterophilic Antibodies

As described previously, the majority of commercial assays used to detect hCG use monoclonal antibodies in a sandwich assay. Some individuals have circulating factors in their serum that interact with the hCG antibody. The most common are heterophilic antibodies (5). These are human antibodies directed against animal-derived antigens used in immunassays. Multiple studies have reported the presence of serum antibodies that can

Box 1. Potential Causes of Elevated Human Chorionic Gonadotropin Levels*

Assay interference ("false-positive hCG")

Heterophilic antibodies

Interference from other endogenous serum proteins (bilirubin, hemoglobin) and lipids

Pituitary hCG (especially in menopausal patients)

Chronic kidney disease

History of bladder augmentation (enterocystoplasty)

Nongynecologic malignancy (breast, gastrointestinal, genitourinary, lung, head and neck, osteosarcoma, testicular)

Familial hCG syndrome

Exogenous hCG (eg, use for weight loss, to stimulate endogenous androgen production in athletes, hCG trigger injections for infertility treatments, Munchausen's syndrome)

hCG, human chorionic gonadotropin.

Data adapted from Oyatogun O, Sandhu M, Barata-Kirby S, Tuller E, Schust DJ. A rational diagnostic approach to the "phantom hCG" and other clinical scenarios in which a patient is thought to be pregnant but is not. Therap Adv Reprod Health 2021;15:1-13. doi: 10.1177/26334941211016412; Braunstein GD. False-positive serum human chorionic gonadotropin results: causes, characteristics, and recognition. Am J Obstet Gynecol 2002;187:217-24. doi: 10.1067/mob.2002.124284; Azimi V, Budelier MM, Gronowski AM. Decreased renal function is associated with mild elevations of hCG in women >40 years of age. Clin Chem 2021;67:1567-9. doi: 10.1093/clinem/hvab177; and Vasquez E, Dillon H, Hannallah A, Wang Y, Baker Z. False positive pregnancy tests in pediatric patients with augmentation enterocystoplasty. J Pediatr Urol 2022;18: 615.e1-6. doi: 10.1016/j.jpurol.2022.09.008.

*Outside of gestational trophoblastic disease and pregnancy.

produce a positive serum assay (9, 10). These antibodies often bind animal proteins and may occur more often in patients who have frequent contact with goats, rabbits, and mice. The antigens used in commercial assays are often animal-generated, and interference from the anti-animal antibodies can cause false-positive test results.

Pituitary hCG

Another potential cause of elevated hCG levels, particularly in postmenopausal and perimenopausal patients, is hCG produced by the pituitary (1, 11). Decreased production of ovarian estrogen in perimenopausal and menopausal patients results in decreased negative feedback on gonadotropin-releasing hormone. Elevated levels of hCG produced by the pituitary are seen in conjunction with elevated FSH and LH levels. These increased levels may occur due to the proximity of the beta subunit of hCG to the beta subunit of LH of chromosome 19 and increased gonadotropin-releasing hormone stimulation (1, 6).

Genitourinary Disease

Patients with renal failure have been reported to have elevated levels of serum hCG due to failure of the kidneys to filter the protein into urine (12, 13). The levels seen are typically less than 100 international units/L (1) and often less than 25 international units/L (12). In perimenopausal and postmenopausal patients with renal failure, pituitary hCG and renal failure together may produce

a greater likelihood of persistent low levels of hCG on serum assays.

Patients with prior bladder reconstruction using bowel, or enterocystoplasty, also may have elevated urine hCG levels, although the mechanism is not well understood (14).

Familial hCG Syndrome

Familial hCG syndrome is a rare genetic defect that affects both women and men (15) at an estimated incidence of 1 in 60,000 families (6). In this syndrome, affected patients produce hCG with absent or modified C-terminal peptide, leading to elevated hCG levels in some assay results (6).

It is important that health care professionals consider the different causes of elevated hCG outside of pregnancy and gynecologic malignancy when evaluating patients with persistently elevated hCG test results. Appropriate retesting to rule out various etiologies and to identify the main cause of persistently elevated hCG is necessary to avoid misdiagnosis or mismanagement of elevated hCG levels.

Management of Persitently Elevated hCG levels

Health care professionals should follow a systematic approach to retesting and evaluating test results that considers patient history, outcomes

from previous tests and assays, and patient risk for other underlying causes of a positive hCG test result.

Due to the multiple potential etiologies of persistently elevated hCG levels, health care professionals should evaluate test results according to a systematic framework. When serum hCG test results are elevated, the first step is to evaluate for pregnancy (both intrauterine and ectopic). Depending on the hCG level as well as the individual's obstetric and gynecologic history, gestational trophoblastic disease would be next in the differential diagnosis. Molar pregnancy and trophoblastic malignancy may be associated with hCG levels greater than 100,000 milli-international units/mL. For lower-level hCG elevations, pelvic imaging and serial hCG testing are appropriate steps to assess for retained products of conception, ectopic pregnancy, persistent gestational trophoblastic neoplasia, and malignancy. Excluding these conditions, the algorithm shown in Figure 2 provides suggested next steps for health care professionals to evaluate for persistently elevated hCG levels.

Heterophilic Antibodies

Health care professionals should be aware of alternative retesting methods to identify heterophilic antibodies that would result in false-positive hCG test results.

Because different immunoassays use different antibodies, a different hCG assay may not yield a false-positive test result and therefore may provide a more accurate assessment. Direct communication and consultation with the clinical laboratory and laboratory medicine specialists are important to discuss alternative assays and options for complex situations. Because the interfering antibodies are too large to be filtered into the urine, paired testing with urine hCG should be performed for results with a serum hCG higher than 50 milli-international units/mL. A negative urine hCG in the setting of a serum hCG higher than 50 milli-international units/mL is diagnostic of heterophilic antibodies (16).

Serial dilutions of the serum also can be performed to rule out heterophilic antibody interference. In the setting of a true-positive hCG test result, the hCG concentration should fall approximately linearly based on the dilution. Lack of linearity confirms assay interference. Additionally, some laboratories can preabsorb serum to remove heterophilic antibodies before performing the assay. If the result becomes negative after removal of the heterophilic antibody, interference can be confirmed.

It is important to note that not all laboratories can perform the above-mentioned ancillary testing. Discussions with laboratory directors or academic centers may be helpful in obtaining necessary testing or determining

![graph TD\n A1[Positive Serum hCG] --> A2[Perform urine hCG test]\n A2 --> A3[Negative]\n A2 --> A4[Positive]\n A3 --> A5[Heterophilic antibodies]\n A4 --> A6[Perimenopause; pituitary source]\n A4 --> A7[Renal Disease]\n A4 --> A8[Non-trophoblastic disease]\n A4 -->|Other causes of persistently elevated hCG when GTD and pregnancy have been ruled out| A9[Family hCG syndrome]\n A6 --> A10[Exogenous hCG]\n A7 --> A11[Endometrioplasty]\n A8 --> A9\n A9 -->|Less common| A10\n A10 -->|More common| A6\n](1/parseimages/figure2c8f6e71a7b7436e8056300686bf8fe0_0_7.png) Management of Positive Human Chorionic Gonadotropin Test. Obstet Gynecol 2026.

whether referral to a center with more detailed testing capability is warranted.

Pituitary hCG

In postmenopausal patients with elevated FSH levels and stable low levels of hCG (less than 14 international units/L), it is most likely that the hCG detected is produced by the pituitary (17). If FSH is in a menopausal range (40 international units/L or higher), no further testing is required (17). However, if there is concern about the clinical picture, a trial of an estrogen-containing hormone pill may confirm the diagnosis by restoring the negative feedback on the hypothalamus, with resultant suppression of pituitary hormone production. Caution should be exercised in patients with contraindications to oral contraceptive pills. Dosing and duration of this method have not been well studied; however, repeat hCG testing after 1 month can be considered. Protection of the endometrium with progesterone is recommended for patients with a uterus on prolonged systemic estrogen therapy.

Familial hCG Syndrome

A thorough family history may help elicit this diagnosis. Most hCG immunoassays are unable to detect hCG without the normal C-terminal peptide region; as such, repeating the hCG test using a different assay may help identify this cause for an elevated hCG level. Despite being a rare condition, health care professionals still should consider the possibility of familial hCG syndrome in the absence of intrauterine and ectopic pregnancy and gestational trophoblastic disease.

Exogenous hCG

In clinical settings, exogenous hCG has been administered to facilitate ovulation during fertility treatment. However, exogenous hCG also has been used in non-clinical settings to induce weight loss and to stimulate endogenous androgen production in athletes (6). Regardless of how the exogenous hCG is administered, levels should decrease within 24–48 hours after administration, provided no subsequent doses have been taken (6).

Nongynecologic Malignancy

Human chorionic gonadotropin levels can be elevated in multiple tumor types as a paraneoplastic syndrome. Elevated hCG has been described in many tumor types, including but not limited to breast, gastrointestinal, genitourinary, lung, squamous cell cancers, and renal tumors (18). In situations in which hCG levels continue to rise and all other differentials have been ruled out, clinicians should consider appropriate imaging or consult with their oncology teams to evaluate for nontrophoblastic causes of elevated serum hCG levels.

Patient Notification and Follow-Up

Patients with evidence of hCG assay interference should be notified that they are at risk for recurrent false-positive hCG assay results. These patients should be instructed to inform all future health care practitioners of this issue, and the information should be documented in the patient's medical record.

USE OF LANGUAGE

The American College of Obstetricians & Gynecologists (ACOG) recognizes and supports the gender diversity of all patients who seek obstetric and gynecologic care. In original portions of this document, authors seek to use gender-inclusive language or gender-neutral language. When describing research findings, this document uses gender terminology reported by investigators. To review ACOG's policy on inclusive language, see Inclusive Language.

REFERENCES

1. Bidot S, Duggan J, Bryksin J. Persistent elevation of serum human chorionic gonadotropin in a nonpregnant woman. J Appl Lab Med 2021;6:1366-70. doi: 10.1093/jalm/jfaa222 2. Grenache DG. Current practices when reporting quantitative human chorionic gonadotropin test results. J Appl Lab Med 2020;5:850-7. doi: 10.1093/jalm/jfaa082 3. Patel KK, Qavi AJ, Hock KG, Gronowski AM. Establishing reference intervals for hCG in postmenopausal women. Clin Bio-chem 2017;50:234-7. doi: 10.1016/j.clinbiochem.2016.11.017 4. Snyder JA, Haymond S, Parvin CA, Gronowski AM, Grenache DG. Diagnostic considerations in the measurement of human chorionic gonadotropin in aging women. Clin Chem 2005;51: 1830-5. doi: 10.1373/clchem.2005.053595 5. Braunstein GD. False-positive serum human chorionic gonadotropin results: causes, characteristics, and recognition. Am J Obstet Gynecol 2002;187:217-24. doi: 10.1067/mob.2002.124284 6. Oyatogun O, Sandhu M, Barata-Kirby S, Tuller E, Schust DJ. A rational diagnostic approach to the "phantom hCG" and other clinical scenarios in which a patient is thought to be pregnant but is not. Ther Adv Reprod Health 2021;15:26334941211016412. doi: 10.1177/26334941211016412 7. United Nations Development Programme. Human Development Index (HDI). Accessed November 7, 2025. https://hdr.undp.org/data-center/human-development-index#/indicies/HDI 8. Cole LA, Khanlian SA. Inappropriate management of women with persistent low hCG results. J Reprod Med 2004;49:423-32. 9. Gehin JE, Klaasen RA, Norli ES, Warren DJ, Syversen SW, Goll GL, et al. Rheumatoid factor and falsely elevated results in commercial immunoassays: data from an early arthritis cohort. Rheumatol Int 2021;41:1657-65. doi: 10.1007/s00296-021-04865-9 10. Knight AK, Bingemann T, Cole L, Cunningham-Rundles C. Frequent false positive beta human chorionic gonadotropin tests in immunoglobulin A deficiency. Clin Exp Immunol 2005;141: 333-7. doi: 10.1111/j.1365-2249.2005.02837.x 11. Schmid BC, Reilly A, Oehler MK. Management of nonpregnant women with elevated human chorionic gonadotropin. Case Rep Obstet Gynecol 2013;2013:580709. doi: 10.1155/2013/580709

12. Azimi V, Budelier MM, Gronowski AM. Decreased renal function is associated with mild elevations of hCG in women >40 years of age. Clin Chem 2021;67:1567–9. doi: 10.1093/cinchem/hvab177 13. Yadav K, Doddi S, Sindhwani P, Nadiminty N, Malhotra D, Ratnam S, et al. False positive pregnancy test before kidney transplant: case report and review of literature. Transplant Proc 2022;54:1612–4. doi: 10.1016/j.transproceed.2022.04.018 14. Vasquez E, Dillon H, Hannallah A, Wang Y, Baker Z. False positive pregnancy tests in pediatric patients with augmentation enterocystoplasty. J Pediatr Urol 2022;18:615–1.6 doi: 10.1016/j.jpurol.2022.09.008 15. Cole LA. Familial HCG syndrome. J Reprod Immunol 2012;93: 52–7. doi: 10.1016/j.jri.2011.11.001 16. Rotmensch S, Cole LA. False diagnosis and needless therapy of presumed malignant disease in women with false-positive human chorionic gonadotropin concentrations [published erratum appears in Lancet 2000;356:600]. Lancet 2000;355:712–5. doi: 10.1016/S0140-6736(00)01324-6 17. El Hage L, Hatipoglu B. Elevated hCG can be a benign finding in perimenopausal and postmenopausal women. Cleve Clin J Med 2021;88:635–9. doi: 10.3949/ccjm.88a.18069 18. Stenman U, Alfthan H, Hotakainen K. Human chorionic gonadotropin in cancer. Clin Biochem 2004;37:549–61. doi: 10.1016/j.clinbiochem.2004.05.008 APPENDICES 1. Literature search strategy: http://links.lww.com/AOG/E455 2. Evidence map: http://links.lww.com/AOG/E456

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Published online on January 15, 2026. Copyright 2026 by the American College of Obstetricians & Gynecologists. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on the internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher.

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Management of positive human chorionic gonadotropin test results in nonpregnant patients without gynecologic malignancy. Clinical Consensus No. 11. American College of Obstetricians & Gynecologists. Obstet Gynecol 2026;147:e32-e38.