βhCG

The biomarker of choice to aid in the early detection of pregnancy

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Infection (PCT, CRP) Myocardial infarction (TnI, CKBM, Myo) Heart failure (NT-proBNP) Pregnancy (ßhCG) Venous thromboembolism (D-dimer)

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Download customer testimonial POC βhCG Immunoassay: Transforming patient care in an Emergency Gynaecological Unit. From The Royal London Hospital, United Kingdom

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Fast results
Quantitative results
Early pregnancy detection

Pregnancy testing in the emergency department

Testing for pregnancy is common clinical practice when women are admitted to the emergency department (ED). Pregnancy is often the clinical cause of the symptoms at presentation, and can also be a risk factor for other serious disorders, including urinary tract infection and venous thromboembolism (VTE) [1,2].

When a woman presents with symptoms such as severe abdominal pain or swelling of the legs or has trauma requiring radiography, a fast and accurate pregnancy test can provide critical information for further treatment and management of the patient’s disorder

A quantitative blood test measuring beta human chorionic gonadotropin (ßhCG), performed at the point-of-care, can rapidly deliver accurate results for this purpose [3].

Immunoassay products and solutions

CRP (C-reactive protein)

D-dimer

NT-proBNP

Procalcitonin (PCT)

Troponin I

ßhCG - an effective biomarker for pregnancy

ßhCG is a hormone produced by the placenta during pregnancy. It induces estrogen and progesterone production while suppressing the maternal immune system to sustain the growing fetus [4, 5].

Most pregnancy tests measure ßhCG levels, which rise quickly in the first few weeks of pregnancy. ßhCG can be detected in blood and urine samples but is typically more concentrated in blood. Pregnancy blood tests can detect ßhCG about 11 days after conception, several days earlier than standard urine tests [6].

Pregnancy blood tests are also more sensitive than typical urine dipstick tests, providing quantitative results to support clinical evaluation [3].

Implications of pregnancy for clinical management

Pregnancy may significantly affect the management of a patient’s disorder. This is particularly the case with common comorbidities – such as VTE, asthma, diabetes, hypertension, and various types of infections – where pregnancy has implications for the dosage and usage of certain antibiotics, anticoagulation and other treatments [7].

Pregnancy is also an indication to minimize unnecessary radiographic treatments, such as X-rays, which could potentially harm the developing fetus. General guidance recommends that a pregnancy test should be considered prior to radiography if a patient’s period is overdue [8].

ßhCG testing at the point of care accelerates ED turnaround time

ßhCG blood testing has additional advantages at the point-of-care compared to standard urine testing. Studies indicate that point-of-care blood testing may reduce the overall turnaround time for results [9].

A key reason for this reduction is that blood testing circumvents the need to wait for urine samples. Significant delays may occur if patients are not ready to provide urine or are unable to provide samples due to illness or injury.

Testing ßhCG on the Radiometer AQT90 FLEX

The AQT90 FLEX analyzer delivers lab-standard quantitative results on the ßhCG assay in less than 19 minutes, accelerating pregnancy diagnosis in the ED to support rapid clinical decision making.

The AQT90 FLEX immunoassay analyzer is a benchtop analyzer that brings rapid biomarker assessment capabilities right to the patient’s bedside.

Its closed tube system makes ßhCG testing easy: the operator simply inserts the sample tube into the tube holder in the sample port and the analyzer performs all assay steps automatically. There is no need for sample preparation.

All necessary reagents are included in the test cartridges, which remain stable onboard the analyzer for 20 days ensuring maximum availability and uptime.

Learn more about the AQT90 FLEX analyzer

Quick facts on ßhCG assay on the AQT90 FLEX analyzer

Specimen types: venous whole blood and plasma
Sample tubes: fit most 13 × 75 mm standard tubes
No blood exposure: closed system
No sample or assay preparation
High analytical performance
No presence of hook effect
Hemolysis, lipemia, icteria and biotin* show no interference with the assay.

*No interference was observed with biotin up to 2.6 mg/L (2,600 ng/mL).

ßhCG assay specifics

Turnaround time:

18.09 min

CV % (plasma): Within-lab CV % at conc. 3.1 IU/L: 17.2 %

95th percentile* : Females (all) < 6 IU/L
Pre-menopausal < 2 IU/L
Males < 0.5 IU/L

Traceability: Harmonized to correlate with results of IU/L WHO, 75/589

* These values should only be used as an example. Each laboratory should establish its own decision threshold level.

References

1. NICE guideline [NG126] Published date: 17 April 2019
2. Tintinalli J, Thomas S, Ma J, et al. Emergency Medicine, A Comprehensive Study Guide, McGraw-Hill Education, Oct. 2019
3. Fromm C, Likourezos A, Haines L, et al. Substituting whole blood for urine in a bedside pregnancy test. J Emerg Med. 2012;43(3): 478–82.
4. Korevaar TIM, Steegers EAP, de Rijke EB, et al. Reference ranges and determinants of total hCG levels during pregnancy: the generation R study. Eur J Epidemiol. 2015; 30: 1057–66.
5. Castillo JC, Humaidan P, Bernabéu R. Pharmaceutical options for triggering of final oocyte maturation in ART. Biomed Research International. 2014; Art.ID. 580171.
6. Chard T., REVIEW: Pregnancy tests: a review. Human Reproduction. 1992; 7: 701–710.
7. Niebyl JR. Drug use in pregnancy and lactation. In: Pearlman MD, Tintinalli JE, eds. Emergency Care of the Woman. New York: McGraw Hill; 1998: 165–178.
8. British Institute of Radiology, Society and College of Radiographers and the Royal Society of Radiologists. A guide to understanding the implications of Ionising Radiation (Medical exposure). Regulations in diagnostic and interventional radiology. London; The Royal Society of Radiologists, 2015.
9. Gottlieb et al. Comparison of Urine and Whole Blood Pregnancy Testing. Western Journal of Emergency Medicine. 2016; 17:449–453