β-hCG CLIA Test CE

The β-hCG (hCG) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of β-hCG in human serum or plasma (sodium heparin, K2EDTA or K3EDTA) using the ALTA CLIAlyzer.

hCG is involved in a variety of functions, including maintenance of the corpus luteum and progesterone production as well as various other functions associated with the placenta, uterus, and fetus such as development of the umbilical cord, development of fetal organs, angiogenesis, suppression of uterine contractions, immunosuppression and protection from invading cells.

Abnormally low levels of hCG during pregnancy may indicate issues such as a failing pregnancy, placental insufficiency, ectopic pregnancy, fetal death, preeclampsia, and preterm delivery. High levels of hCG during pregnancy may indicate multiple pregnancies, molar pregnancy, or gestational miscalculation.

Accurate quantification of β-hCG concentration is very important for diagnosis and monitoring of pregnancy. The β-hCG CLIA is intended to be used for diagnosis and monitoring of pregnancy.

  • Individual ready-to-use cartridges
  • Combines the sandwich immunoassay technique with enzyme catalyzed chemiluminescence detection
  • Calibration kit follows the national standard for hCG
  • Sample volume: 60 μL

Range

Working range: 1-5000 mIU/mL

Detection Limits

Limit of Detection (LOD): 1 mIU/mL

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 15%

Accuracy

Accuracy of ± 10% in comparison to the control

Linearity

Linearity between 1 and 5000 mIU/mL

Specificity

No significant cross-reactivity was observed when TSH (100 µIU/mL), FSH (200 mIU/mL) or LH (200 mIU/mL) was added to the b-hCG Calibrator CAL 1. The results of b-hCG in these samples were less than 3.0 mIU/mL.

Interference

No significant interference was detected up to the concentrations mentioned below:

SubstanceConcentration
Hemoglobin500 mg/dL
Bilirubin20 mg/dL
Triglyceride3000 mg/dL
Total Protein10 g/dL
Rheumatoid Factor1500 IU/mL

HAMA Interference 

Patient specimens containing human anti-mouse antibodies (HAMA) may give falsely elevated or decreased values.  Although HAMA-neutralizing agents are added, extremely high HAMA serum concentrations may occasionally affect the results.

Hook effect

There is no high-dose hook effect at b-hCG concentration up to 300,000 mIU/mL.

Reagents and Materials provided:

  1. 19-well b-hCG reagent cartridge
    1. Sample well (1st well)
    2. Reading well for chemiluminescent signal (19th well)
    3. Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
  2. 3 Calibrators containing b-hCG protein at:
    1. 0 mIU/mL
    2. 5 mIU/mL a
    3. 500 mIU/mL
  3. 2-level quality controls* containing b-hCG protein at:
    1. 25 mIU/mL
    2. 500mIU/mL
  4. Registration card
  5. Calibrator card
  6. Quality Control Sheet
  7. Instructions for Use

*Quality control values are lot specific and refer to the quality control sheet.

Materials required but not provided:

  1. Pipette with disposable tip to dispense up to 100 μL
  2. For other specific materials and disposables, refer to CLIAlyzer user manual
  3. CLIAlyzer instrument
  4. Powderless gloves
CATALOG #PRODUCTQUANTITYSPECIMEN
L1000β-hCG CLIA Test36/kitS/P
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MATERIALS REQUIRED BUT NOT PROVIDED:
CLIA-1CLIAlyzer  

FOR EXPORT ONLY