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Test Code LAB143 Human Chorionic Gonadotropin (hCG), Quantitative,Plasma or Serum

Reporting Title

Beta-hCG, Quant, Plasma or Serum

Methodology

Roche Diagnostics, Electrochemiluminescence Immunoassay  RMH, GMC, DH, DMH, GMH, WECC, PMH, GCMH, BH, OBH, MGH, MH, HMH, SH

 

Note:  Test detects intact hCG, holo-hormone “nicked” form of hCG, beta-core fragment, and free beta-subunit.

This test is intended for early detection of pregnancy. It is decreased with ectopic pregnancy, threatened abortion, and intrauterine death. 

Elevated levels can also be found with various tumors (germ-cell, ovaries, liver, lung, stomach, bladder, and pancreas) and hydatiform mole.  Order LAB93674 Beta HCG Tumor Marker, if tumor is suspected.

 

VWH Lab Only:

The Access Total βhCG5 assay is a two-site immunoenzymatic (“sandwich”) assay. A sample is added to a reaction vessel with rabbit anti-βhCG-alkaline phosphatase conjugate, and paramagnetic particles coated with goat anti-mouse IgG: mouse monoclonal anti-βhCG complexes. The hCG binds to the immobilized monoclonal anti-βhCG on the solid phase while, at the same time, the rabbit anti-βhCG-alkaline phosphatase conjugate reacts with different antigenic sites on the hCG. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate Lumi-Phos* 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of hCG in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve.

Performing Laboratory

OhioHealth Laboratory Services-RMH,GMC, DH, DMH, MGH, GMH, HMH, OBH, MH, SH,GCMH, BH, PMH, WECC and VWH Core Laboratories

Specimen Requirements

Due to interference, patients receiving high doses of biotin (>5 mg/day) should wait at least 8 hours after dose before having blood drawn.

 

Collection Instructions:

1. Serum and Plasma gel tubes should be centrifuged within 2 hours of collection.

2. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.

 

Submit only 1 of the following specimens:

 

Preferred:

Plasma

Draw blood in a mint green-top (heparin) gel tube(s). Spin down and send 1 mL of heparinized plasma refrigerated.

Note: 

1. Indicate plasma on request form.

2. Label specimen appropriately (plasma).

 

Alternate:

Serum

Draw blood in a gold-top serum gel tube(s). Spin down and send 1 mL of serum refrigerated.
Note:

1. A speckled-top serum gel tube (s) or a plain, red-top tube(s) is also acceptable.

2. Indicate serum on request form.

3. Label specimen appropriately (serum).

 

Roche Specimen Stability Information

Specimen Type Temperature Time
Serum or plasma Refrigerated 14 days
  Ambient  5 days
  Frozen  12 months

 

VWH Lab Additional Collection Instructions:

1. Serum and plasma (heparin) are the recommended samples.

2. Observe the following recommendations for handling, processing, and storing blood samples:

  • Collect all blood samples observing routine precautions for venipuncture.
  • Allow serum samples to clot completely before centrifugation.
  • Keep tubes stoppered at all times.

3. Within two hours after centrifugation, transfer at least 500 μL of cell-free sample to a storage tube. Tightly stopper the tube immediately.

  • Store samples tightly stoppered at room temperature (15 to 30°C) for no longer than eight hours.
  • If the assay will not be completed within eight hours, refrigerate the samples at 2 to 8°C for up to 48 hrs. 

Specimen Transport Temperature

Refrigerate/Ambient OK/Frozen NO

Reference Values

hCG ≥25 mIU/mL is considered diagnostic of a viable pregnancy.

Males and nonpregnant females:  < 5 mIU/mL

Females during normal pregnancy

3-4 weeks:  9-130 mIU/mL

4-5 weeks:  75-2,600 mIU/mL

5-6 weeks:  850-20,800 mIU/mL

6-7 weeks:  4,000-100,200 mIU/mL

7-12 weeks:  11,500-289,000 mIU/mL
12-16 weeks:  18,300-137,000 mIU/mL

16-29 weeks:  1,400-53,000 mIU/mL

29-41 weeks:  940-60,000 mIU/mL

 

VWH Lab Only:

Approximate Gestational Age (weeks)

Approximate hCG Range (mIU/mL, IU/L
0.2–1 5–50
1–2 50–500
2–3 100–5,000
3–4 500–10,000
4-5 1,000–50,000
5-6 10,000–100,000
6-8 15,000–200,000
8-12 10,000–100,000

 

Day(s) Test Set Up

Monday through Sunday; Continuously

Test Classification and CPT Coding

84702