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Test Code hCG Qual U hCG Qualitative Urine

Additional Codes

Cerner

NextGen

Pregnancy Test Urine

hCG Qualitative Urine

HCG Urine

 

Alternate Name(s)

Beta HCG qualitative

Pregnancy test, urine

βHCG

Useful For

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the trophoblastic cells of the placenta. The primary function of hCG is to maintain the corpus luteum during early pregnancy. The hCG consists of about 70% protein and 30% carbohydrate and is made up of an alpha subunit that is very similar to the alpha subunits of LH, FSH, and TSH. The hCG also has a beta subunit that is similar to the LH beta subunit but immunochemically distinct. Tests for confirming pregnancy are based on detecting elevated levels of beta hCG.

Methodology

The SPTM Brand Rapid Test hCG Combo is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including mouse monoclonal anti-hCG antibodies and goat polyclonal anti-hCG antibodies to selectively detect elevated levels of hCG.

Patient Preparation

None

Collection Instructions

Catheterized specimens collected according to clinical policies and procedures

Radom clean catch instructions: Random Urine Collection Instructions

Specimen Requirements

Container
  • Sterile/clean plastic urine container

 or  or 

  • Non-preservative urine tube (BD Vacutainer® Ref #364980)

 

Stability

Storage

Temperature

Stability

Room Temperature

18-28°C

Not recommended

Refrigerated

 2-8°C

≤ 48 hours

Frozen

≤-20 °C

4 weeks

Thaw 1 time only and mix.

Rejection Criteria

Not Defined

Result Reporting and Reference Values

The SPTM Brand Rapid Test hCG Combo has a sensitivity of 20 mIU/mL in urine and is reported as Positive or Negative

Reflex Testing

None

Limitations

  • False negative results may occur when the levels of hCG are below the sensitivity level of the test.  When pregnancy is still suspected, a first morning urine or serum specimen should be collected 48 hours later and tested.
  • Very low levels of hCG (less than 50 mIU/mL) are present in urine and serum specimen shortly after implantation.  However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine or serum specimen collected 48 hours later.
  • A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hCG. Therefore, the presence of hCG in urine or serum specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.
  • As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen.  Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA.  Such specimens may cause false positive or false negative results.
  • This test provides a presumptive diagnosis for pregnancy.  A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
  • The addition of LH (300 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL hCG) and positive (10 mIU/mL hCG in serum; 20 mIU/mL hCG in urine) specimens showed no cross-reactivity.
  • Interfering Substances: 

 

The following potentially interfering substances were added to hCG negative and positive specimens. None of the substances at the concentration tested interfered in the assay.

 

Acetaminophen                       20 mg/dL                     Caffeine                      20 mg/dL

Acetylsalicylic Acid                 20 mg/dL                     Gentisic Acid               20 mg/dL

Ascorbic Acid                          20 mg/dL                     Glucose                       2000 mg/dL

Atropine                                   20 mg/dL                     Hemoglobin                 1000 mg/dL

Bilirubin                                   20 mg/dL                     Salicyclic Acid             20 mg/dL

Triglycerides                           1200 mg/dL