• high quality

  -

  developed for the World Health Organization (WHO)

  -

  used in WHO international research projects

  -

  used in 25 countries worldwide

  -

  performs well in national and international EQA Schemes

• high performance

  -

  detection limit <2 IU/L WHO IRP 75/537

  -

  between-assay CV better than 10% in range 10 - 1000 IU/L

  -

  no high dose hook effect up to 800,000 IU/L

• low cost

  -

  all reagents are provided - only test tubes and water are required

  -

  uses inexpensive, robust equipment

  -

  each kit is sufficient for 100 assay tubes

• convenient

  -

  magnetic separation

  -

  2 hours total incubation time

  -

  shelf life of 1 year at 4-8°C

For information and prices please contact us.

The assay is an immunometric ('sandwich') EIA for the quantitative measurement of hCG in human serum or plasma and for qualitative urine pregnancy testing. Sample hCG is bound by 2 monoclonal anti-hCG antibodies directed at different epitopes. One antibody is attached to magnetic particles and the other is labelled with alkaline phosphatase. The assay has four main stages:

• Magnetic anti-hCG is incubated with sample (100 µL) for 15 minutes at 37°C followed by 2 magnetic wash steps.
• The magnetic particles are incubated with alkaline phophatase labelled anti-hCG for 1 hour at 37°C followed by 2 magnetic wash steps.
• A coloured enzyme substrate is incubated with the particles for 30 minutes at 37°C. The presence of alkaline phosphatase causes a colour change from yellow to pink. The reaction is terminated by addition of Stop Buffer.
• The tubes are then placed in the spectrophotometer or colorimeter. The optical density (at 550nm or 492nm) of each tube can be measured and the results calculated using a data processing program.

See diagram popup.

Incubation times	15 mins + 1 hr + 30 mins
Standard Range	0-900 IU/L Standardised against WHO IRP 75/537
Normal Ranges	Male <8 |IU/L Non-Pregnant female <8 |IU/L
Detection Limit	2   IU/L
Assay Reproducibility	Within-batch ±1SD IU/L %CV 11.0±0.6 5.1 53±2 3.6 212±9 4.4 363±13 3.7
Assay Reproducibility	Between-batch ±1SD IU/L %CV 11.5±1.7 14.7 50.0±3.5 7.1 250±19 7.7 427±48 11.1

hCG EIA Standards - see (*) hCG EIA Magnetic Antibody hCG EIA Enzyme Labelled Antibody hCG EIA Assay Buffer hCG EIA Wash Buffer

EIA Substrate Reagent EIA Substrate Buffer EIA Stop Buffer EIA Internal QC Sample Instruction booklet

(*) - calibrated against WHO IRP 75/537

Test tubes, pipettes, multivortex mixer, magnetic separator, 37°C water- bath and a colorimeter or spectrophometer.