HCG Quant(Abbott)

Test Code

HCG QUANT(Abbott)

Alias/See Also

BHCG, Pregnancy
Chemistry

Preferred Specimen

Gold Top Tube

Minimum Volume

2 mL

Transport Temperature

Refrigerate

Specimen Stability

Refrigerated (2-8°C): 7 days
Frozen (-20°C or colder): 1 year
If testing delayed > 25 hours remove from clot/gel

Methodology
The Alinity i Total β-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (β-hCG) in human serum and plasma.
Patient results determined by assays using different manufacturers or methods may not be comparable.

Setup Schedule

M - F

Report Available

TAT 1 day

Limitations

HCG quantitative testing on males was developed and its performance characteristics determined by VA West Roxbury Laboratory. It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.

This assay is capable of detecting whole molecule (intact) hCG as well as free β-hCG subunits.
For diagnostic purposes, hCG results should always be used in conjunction with other data; e.g., patient’s medical history, symptoms, results of other tests, clinical impressions, etc. Ectopic pregnancy cannot be distinguished from normal pregnancy by hCG measurements alone. The results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.14, 15
If the hCG level is inconsistent with, or unsupported by, clinical evidence, results should be confirmed by an alternate hCG method. This may include the qualitative testing of urine. The absence of urinary hCG may suggest a falsely elevated serum result. Results may also be confirmed by performing serial dilutions of the sample. Usually, but not always, samples that contain interfering substances exhibit nonlinear results when diluted.16
The Alinity i Total β-hCG assay is cleared for use in the early detection of pregnancy only. It is not approved for any other uses such as tumor marker screening, tumor marker monitoring, etc. and it should not be performed for any other uses.

Infrequently, hCG levels may appear consistently elevated and could be due to, but not limited to, the presence of the following:16, 17, 18, 19, 20

heterophilic antibodies
nonspecific protein binding
hCG-like substances
trophoblastic or nontrophoblastic neoplasms
As with any immunochemical reaction, unknown interferences from medications or endogenous substances may affect results.
Elevated hCG levels have been associated with some pathological conditions (e.g., trophoblastic and nontrophoblastic neoplasms) and the results of this test should not be used in the diagnosis of these abnormal states. There have been reports of people receiving unnecessary medical treatment and surgery, including chemotherapy and hysterectomy, when hCG results were used in the diagnosis of abnormal conditions.21, 22
Interfering substances (such as heterophilic antibodies, non-specific proteins, or hCG-like substances) may falsely depress or falsely elevate results. These interfering substances may cause false results over the entire range of the assay, not just at low levels, and may indicate the presence of hCG when there is none.
Detection of very low levels of hCG does not rule out pregnancy. Low levels of hCG can occur in apparently healthy, nonpregnant subjects. Because hCG values double approximately every 48 hours in a normal pregnancy, patients with very low levels of hCG should be resampled and retested after 48 hours.18, 23, 24
Post-menopausal specimens may have low levels of hCG levels unrelated to pregnancy. It is good clinical practice to resample and retest after 48 hours, or to test with an alternate hCG method.
Because of the high degree of sensitivity of the assay, specimens tested as positive during initial days after conception may later be negative due to natural termination of the pregnancy. Natural termination occurs in 22% of clinically unrecognized pregnancies and 31% of pregnancies overall.25
Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). Such specimens may show either falsely elevated or depressed values when tested with assay kits such as Alinity i Total β-hCG that employ mouse monoclonal antibodies. Additional information may be required for diagnosis.26, 27
Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference, and anomalous values may be observed. Additional information may be required for diagnosis.17, 18

Reference Range

0 - 5 mIUnits/mL

Clinical Significance

hCG may reach detectable limits within 7-10 days of conception. hCG is produced by the placenta and reaches a peak between the 7th and 10th week of gestation. hCG is a glycoprotein hormone produced by the syncytiotrophoblast of the placenta and secreted during normal pregnancy and with pathologic conditions such as hydatidiform mole, choriocarcinoma and testicular neoplasm. Order hCG, Total, Qualitative, Urine, if hCG serum result is inconsistent with clinical presentation.

Performing Laboratory
Test performed at West Roxbury Chemistry Lab
Contact: Jonathan Dryjowicz-Burek 857-203-5973

Last Updated: December 19, 2025

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.