False-Negative Results in Point-of-Care Qualitative Human Chorionic Gonadotropin (hCG) Devices Due to Excess hCGβ Core Fragment

Gronowski, Ann M.; Cervinski, Mark A.; Stenman, Ulf‐Håkan; Woodworth, Alison; Ashby, Lori; Scott, Mitchell G.

doi:10.1373/clinchem.2008.121210

Cited by 68 publications

(64 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This effect was predicted in 2000 by Madersbacher and Berger (15 ) and highlights the need for appropriate selection of antibodies and assay design (17 ). In 2009 Gronowski et al demonstrated that this phenomenon occurred with some qualitative hCG devices (9,10 ). One limitation of this study was that measurements were made in singleton and not in duplicate, due to the expense of the purified materials.…”

Section: Discussionmentioning

confidence: 91%

“…However, laboratorians sometimes use quantitative serum assays to detect hCG in urine when investigating discrepant hCG results (9,18,19 ). As such, knowledge of the potential influence of hCG␤cf, a predominant hCG variant in urine after 5 weeks of pregnancy, on quantitative hCG assays is essential for accurate result interpretation.…”

Section: Discussionmentioning

confidence: 99%

“…Some qualitative point-of-care hCG devices have been reported to demonstrate false-negative results in the presence of increased concentrations of hCG␤cf, hCG␤, nicked hCG␤, and nicked hCG (9,10 ). In light of these findings, we hypothesized that the same would be true for quantitative hCG assays.…”

confidence: 92%

“…Human chorionic gonadotropin (hCG) 9 is a molecularly heterogeneous molecule. The biologically active hormone (intact hCG) is composed of noncovalently linked ␣ and ␤ subunits.…”

confidence: 99%

See 3 more Smart Citations

Falsely Decreased Human Chorionic Gonadotropin (hCG) Results Due to Increased Concentrations of the Free β Subunit and the β Core Fragment in Quantitative hCG Assays

et al. 2010

Self Cite

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

confidence: 92%

“…Human chorionic gonadotropin (hCG) 9 is a molecularly heterogeneous molecule. The biologically active hormone (intact hCG) is composed of noncovalently linked ␣ and ␤ subunits.…”

confidence: 99%

See 2 more Smart Citations

Falsely Decreased Human Chorionic Gonadotropin (hCG) Results Due to Increased Concentrations of the Free β Subunit and the β Core Fragment in Quantitative hCG Assays

et al. 2010

Self Cite

View full text Add to dashboard Cite

show abstract

“…[2][3][4][5] This is due to the "hook effect" in assays for intact or free β-hCG, whereby βcf-hCG saturates β-hCG-specific antibodies, with the paring antibody unable to recognise the bound βcf-hCG, preventing formation of the antibody sandwich.…”

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

View full text Add to dashboard Cite

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.

show abstract

A rare cause of abdominal pain in early pregnancy

Matiluko

Smith

2010

Trends Urology, Gynecol. Sexual Health

View full text Add to dashboard Cite

twisted, necrotic left tube and ovary were found ( Figure 1). A laparoscopic left salpingo-oophorectomy was performed. The histology report showed extensive haemorrhage and necrosis of the left ovary and fallopian tube, but no evi dence of trophoblastic tissue to suggest ectopic pregnancy.Subsequently, a pelvic ultrasound scan showed a viable intrauterine pregnancy equivalent to eight weeks' gestation. She had vaginal progesterone support for the rest of the fi rst trimester. Her 20-week anomaly scan was normal and she gave birth to a healthy baby girl, at 39 weeks of gestation, by caesarean section for breech presentation. DiscussionTorsion of an ovary and fallopian tube is rare in pregnancy and poses a considerable diagnostic challenge. 1,2 The prevalence of this condition has been estimated at 1 in 1800, 3 but we believe this to be an overestimation.In the case reported here, the pregnancy was initially unrecognised because of a false-negative pregnancy test kit. False-negative qualitative urine pregnancy tests are well documented. 4-8 Qualitative point-of-care and home pregnancy tests both have limitations and are not 100 per cent sensitive in detecting pregnancy. In one study, 5 only 44 per cent of 18 brands gave a clearly positive result at serum beta-human chorionic gonadotrophin (β-hCG) levels of 100mIU/ml. In other words, 56 per cent were falsely negative. In a woman of childbearing age with abdominal pain, we therefore suggest that a negative qualitative urine pregnancy test should be confi rmed by quantitative serum β-hCG measurement.Laparoscopic salpingo-oophorectomy was performed because the tissues appeared necrotic and persistent fever suggested early sepsis. The necrosis was subsequently confi rmed histologically. However, successful detorsion of twisted adnexa has been described regardless of delay in diagnosis and the appearance of the adnexum. 1 A 33-year-old woman was referred to the urology team with a four-day history of left loin pain, syncope and vomiting. She had tachycardia (108 beats per minute), a mildly raised temperature (37.3°C) and tenderness in the left lumbar region and iliac fossa. Urine pregnancy test was negative, but a trace of haemolysed blood was found on ward urinalysis. An intravenous urogram showed no ureteric obstruction. A diagnosis of pyelonephritis was made.However, her pain failed to settle on antibiotics, and a gynaecological opinion was sought two days after admission. On questioning, her last menstrual period transpired to be three months before presentation. She was cardiovascularly stable, but examination revealed abdominal peritonism, a bulky uterus and cervical excitation. A repeat pregnancy test was positive. A clinical diagnosis of ectopic pregnancy was made.The authors present a case history of a pregnant woman with abdominal pain who was found to have torsion of an ovary and fallopian tube. This condition is rare in pregnancy and the case highlights the diagnostic challenges involved. Twisted adnexum Necrotic left tube Necrotic left ovary a b Figure 1. La...

show abstract

False-Negative Results in Point-of-Care Qualitative Human Chorionic Gonadotropin (hCG) Devices Due to Excess hCGβ Core Fragment

Cited by 68 publications

References 16 publications

Falsely Decreased Human Chorionic Gonadotropin (hCG) Results Due to Increased Concentrations of the Free β Subunit and the β Core Fragment in Quantitative hCG Assays

Falsely Decreased Human Chorionic Gonadotropin (hCG) Results Due to Increased Concentrations of the Free β Subunit and the β Core Fragment in Quantitative hCG Assays

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

A rare cause of abdominal pain in early pregnancy

Contact Info

Product

Resources

About