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