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Qualitative hCG Testing

Optimal Testing: ADLM's Guide to Lab Test Utilization

  • Perform qualitative hCG testing to rule out pregnancy in emergent situations prior to performing imaging studies or other interventions that are contraindicated in pregnant women.
  • Urine offers a convenient sample that can be tested immediately at the point of care without a processing step. 
  • Serum requires specimen processing and must be tested in a location equipped with a centrifuge. Where available, quantitative testing in serum specimens is preferred as it provides a numeric value and offers similar turnaround time.Interpret with caution and perform further evaluation if results are inconsistent with the patient’s clinical presentation. 

Guidelines for Test Utilization

What does the test tell me?

Qualitative hCG testing provides a rapid assessment of pregnancy status. A positive result most often indicates pregnancy but may also reflect non-placental hCG production (pituitary hCG in menopausal women, hCG-producing tumors). A negative result generally excludes pregnancy but can also be observed in samples with extremely high or low hCG concentrations. Test results must always be interpreted in the context of the patient’s history, physical exam, timing of specimen collection, and results of other laboratory tests. [back to top]

When should I order this test?

This test should be performed in clinical settings that require a rapid assessment of pregnancy status when quantitative serum/plasma testing is not available within a clinically acceptable time frame. [back to top]

When should I NOT order this test?

Do not order qualitative hCG testing when monitoring abnormal pregnancy or making assessments about pregnancy viability. Qualitative urine hCG testing is also inappropriate for the evaluation and monitoring of hCG-secreting tumors. For both of these indications, serial quantitative plasma or serum hCG measurement is recommended. [back to top]

How should I interpret the result?

A positive result indicates presence of hCG, whereas a negative result indicates absence of hCG. It does not identify the source of hCG production or provide a numeric value that can be trended across multiple timepoints. [back to top]

Is the test result diagnostic/confirmatory of the condition?

No. Qualitative hCG testing is a rapid screening tool. Although test results are most often correct and can be used to guide clinical decisions, false negative and false positive results can occur. Serum/plasma quantitative hCG testing is considered the gold standard as it eliminates many of the limitations of qualitative testing. Ultrasound can also be performed to confirm viable intrauterine pregnancy. [back to top]

Are there factors that can affect the lab result?

False negative results can be encountered:
1. Early in pregnancy when hCG concentrations are low, particularly in dilute urine. 
2. Later in pregnancy when hCG and/or hCG variant concentrations are high, known as the “hook effect”.

Heterophile antibodies may cause false negative or false positive results in serum testing but this is generally not a concern when testing urine.
Invalid results (control line fails to appear) may also be observed when using certain test kits if the patient is taking high-dose biotin. Qualitative testing also introduces human error as it requires subjective visual interpretation and manual documentation of test results in the medical record. [back to top]

Are there considerations for special populations?

N/A [back to top]

What other test(s) might be indicated?

1.If there is a high clinical suspicion for pregnancy and qualitative urine hCG testing is negative OR if a numeric hCG value is needed to guide management of abnormal pregnancy, quantitative serum/plasma hCG testing should be performed. 

2.If a numeric value is not needed, qualitative serum hCG testing may be performed. This eliminates the possibility of false negative results caused by hCG variants found only in urine. However, because specimen processing is required to obtain serum, this testing is typically performed in a central laboratory, which increases the time from collection to result. [back to top]

References

  1. Nichols JH, Ali M, Anetor JI, Chen LS, Chen Y, Collins S, Das S, Devaraj S, Fu L, Karon BS, Kary H, Nerenz RD, Rai AJ, Shajani-Yi Z, Thakur V, Wang S, Yu HYE, Zamora LE. AACC Guidance Document on the Use of Point-of-Care Testing in Fertility and Reproduction. J Appl Lab Med. 2022 Sep 1;7(5):1202-1236. doi: 10.1093/jalm/jfac042. PMID: 36047824.
  2. Nerenz RD, Song H, Gronowski AM. Screening method to evaluate point-of-care human chorionic gonadotropin (hCG) devices for susceptibility to the hook effect by hCG β core fragment: evaluation of 11 devices. Clin Chem. 2014 Apr;60(4):667-74. doi: 10.1373/clinchem.2013.217661. Epub 2014 Jan 24. PMID: 24463559.
  3. Cervinski MA, Lockwood CM, Ferguson AM, Odem RR, Stenman UH, Alfthan H, Grenache DG, Gronowski AM. Qualitative point-of-care and over-the-counter urine hCG devices differentially detect the hCG variants of early pregnancy. Clin Chim Acta. 2009 Aug;406(1-2):81-5. doi: 10.1016/j.cca.2009.05.018. Epub 2009 May 27. PMID: 19477170.

Last reviewed: July 2025. The content for Optimal Testing: the Association for Diagnostics & Laboratory Medicine’s (ADLM) Guide to Lab Test Utilization has been developed and approved by the the Academy of Diagnostics & Laboratory Medicine and ADLM’s Science and Practice Core Committee.

As the fields of laboratory medicine and diagnostic testing continue to grow at an incredible rate, the knowledge and expertise of clinical laboratory professionals is essential to ensure that patients received the highest quality and most useful laboratory tests. ADLM’s Academy and Science and Practice Core Committee have developed a test utilization resource focusing on commonly misused tests in hospitals and clinics. Improper test utilization can result in poor patient outcomes and waste in the healthcare system. This important resource geared toward medical professionals recommends better tests and diagnostic practices. Always consult your laboratory director to make sure these recommendations are appropriate for your patient population.

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