Evaluation of the CLINITEST® Human Chorionic Gonadotropin (hCG) Pregnancy Test for Susceptibility to the Hook Effect by the hCG β Core Fragment

Ledden, David J.; Novamo, A; Schulman, Lloyd S.

doi:10.1373/clinchem.2014.231498

Cited by 3 publications

(1 citation statement)

References 5 publications

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“…However, there is no consensus on what methodology should be used for validation. Spiking samples that contain low levels of intact hCG with high levels of βcf-hCG, which is not observed clinically and thus not physiologically relevant, does not provide relevant information; [7] testing should mimic the extreme clinical scenarios capable of producing false negatives, but should not extend to non-clinically relevant conditions.…”

Section: Introductionmentioning

confidence: 99%

Significance of pregnancy test false negative results due to elevated levels of β-core fragment hCG

Johnson¹,

Eapen²,

Smith³

et al. 2017

Journal of Immunoassay and Immunochemistry

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Very high levels of β-core fragment human chorionic gonadotrophin (βcf-hCG) are reported to potentially cause false negative results in point-of-care (POC)/over-the-counter (OTC) pregnancy tests. To investigate this further, women's daily early morning urine samples, collected prior to conception and during pregnancy, were analysed for intact, free β-, and βcf-hCG. The proportion of βcf-hCG was found to be related to that of hCG produced and in circulation. Therefore, best practice for accuracy testing of POC/OTC pregnancy tests would be to test devices against clinical samples containing high levels of βcf-hCG as well as standards spiked with biologically relevant ratios.

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Section: Introductionmentioning

confidence: 99%

Significance of pregnancy test false negative results due to elevated levels of β-core fragment hCG

Johnson¹,

Eapen²,

Smith³

et al. 2017

Journal of Immunoassay and Immunochemistry

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Development in Biosensor-Based Diagnostics for Bacterial Diseases: Opportunities and Challenges

Sanyal,

Mitra,

Dey

et al. 2024

Smart Nanomaterials Technology

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Assessing the Reliability of Commercially Available Point of Care in Various Clinical Fields

Pezzuto¹,

Scarano²,

Marini³

et al. 2019

TOPHJ

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a Updated and precise molecular diagnostics are essential in disease identification, treatment and management. Conventional technologies are limited to laboratories, which are expensive, require moderate to great volumes of biological fluids and generally create great discomfort among patients. This review discusses some key features of commercially available point of care (POC) devices, such as time to provide results, accuracy and imprecision, in several medical and veterinary fields. We searched Pubmed/Medline using the keywords “point” “of” “care” “device”, selected papers from 1984 to 2019 on the basis of their content and summarized the features in tables. Fast turnaround time and overall good reliability, in terms of accuracy and imprecision, were observed for most of POCs included in the research. POC devices are particularly useful for clinicians since they hold the potential to deliver rapid and accurate results in an inexpensive and less invasive way with an overall improvement of patients' quality of life in terms of time spent at the point-of-care and sample volume withdrawn. These features gain great relevance also in the veterinary practice, where patients’ compliance is generally poor, available sample volumes are quite far from the human ones and analysis costs are higher.

show abstract

Evaluation of the CLINITEST® Human Chorionic Gonadotropin (hCG) Pregnancy Test for Susceptibility to the Hook Effect by the hCG β Core Fragment

Cited by 3 publications

References 5 publications

Significance of pregnancy test false negative results due to elevated levels of β-core fragment hCG

Significance of pregnancy test false negative results due to elevated levels of β-core fragment hCG

Development in Biosensor-Based Diagnostics for Bacterial Diseases: Opportunities and Challenges

Assessing the Reliability of Commercially Available Point of Care in Various Clinical Fields

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