Talk:Pregnancy Test: Difference between revisions

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PMID 22121449
PMID 22121449
===Comparative analysis of the accuracy of urinary hCG tests in vitro===
Rev Assoc Med Bras. 2011 Sep-Oct;57(5):516-22.
[Article in English, Portuguese]
Moraes GS, Amaral Cristovam Rd, Savaris RF.
Source
Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
Abstract
OBJECTIVE:
To identify whether cutoff for sensitivity advertised by three pregnancy tests in urine are compatible to those reported by the manufacturer and to describe their diagnostic performance.
METHODS:
The urine of a male volunteer was used to dilute recombinant β-hCG at defined concentrations of 0, 6.25, 12.5, 25, 50, and 100 mIU/mL. The tubes containing each of the concentrations were coded and blindly assessed for positivity in three different lots of hCG tests: Strip Test Plus®, BioEasy®, and Visitect Pregnancy®. The sample size was calculated for an alpha error of 5%, with a power of 99%.
RESULTS:
All three brands, in their three lots analyzed, had 100% of sensitivity for detecting β-hCG, with 100% negative predictive value, using only negative controls and samples with concentrations equal or higher than the test cutoff (n = 180/brand). The accuracy of the tests was 83% (BioEasy®), 84%(Visitect®) and 91% (Strip Test Plus®). Strip Test Plus® had the best positive likelihood ratio (52.5), while Visitect® had the best negative likelihood ratio (zero).
CONCLUSION:
The three brands have adequate sensitivity for the advertised cutoffs. The Strip Test Plus® test had the best performance to identify urinary concentrations of β-hCG > 12.5 mIU/mL, and consequently, to confirm pregnancy, while Visitect® had the best performance to exclude β-hCG in urine (negative post-test probability: zero).
PMID 22012284

Revision as of 10:38, 13 November 2012

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Cite this page: Hill, M.A. (2024, June 27) Embryology Pregnancy Test. Retrieved from https://embryology.med.unsw.edu.au/embryology/index.php/Talk:Pregnancy_Test


10 Most Recent

Note - This sub-heading shows an automated computer PubMed search using the listed sub-heading term. References appear in this list based upon the date of the actual page viewing. Therefore the list of references do not reflect any editorial selection of material based on content or relevance. In comparison, references listed on the content page and discussion page (under the publication year sub-headings) do include editorial selection based upon relevance and availability. (More? Pubmed Most Recent)

Urine Pregnancy Test

<pubmed limit=10>Urine+Pregnancy+Test</pubmed>

2012

False-positive urine pregnancy test due to leukocyte interference

Ann Lab Med. 2012 Mar;32(2):167-8. doi: 10.3343/alm.2012.32.2.167. Epub 2012 Feb 23.

Jao HF, Er TK, Hsiao JK, Chiang CH. Source Department of Laboratory Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan. PMID 22389886

2011

False-positive urine pregnancy tests--clinicians as detectives

Pan Afr Med J. 2011;8:41. Epub 2011 Apr 10.

Valenzuela R, Iserson KV, Punguyire D. Source Department of Emergency Medicine, University of Medicine and Dentistry of New Jersey, Newark, New Jersey, USA.

Abstract

Reliably diagnosing pregnancy in women presenting with nonspecific abdominal pain can be lifesaving. If diagnostic tests are unreliable, however, valuable time and resources can be wasted pursuing unnecessary and potentially harmful interventions. After four false positive-urine pregnancy tests in one week, we began investigating the laboratory's entire process involving the UPreg tests. We discovered that, as is common in resource-poor settings, the laboratory repeatedly reused test tubes. We found that the false-positive tests resulted from performing the UPreg tests in test tubes that were improperly cleaned and, for the most part, had been used immediately beforehand to test women coming into the maternity ward. Sufficient residua from the pregnant women's high ß-HCG levels had remained in the test tubes to cause subsequent false-positive results in our emergency ward patients. Although pregnancy can now be reliably diagnosed with inexpensive, disposable and simple tests, these tests must not only be used properly, but also, when used in the laboratory, be accompanied by appropriate cleaning and quality-control procedures. This is particularly essential in resource-constrained environments.

PMID 22121449


Comparative analysis of the accuracy of urinary hCG tests in vitro

Rev Assoc Med Bras. 2011 Sep-Oct;57(5):516-22.

[Article in English, Portuguese] Moraes GS, Amaral Cristovam Rd, Savaris RF. Source Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.

Abstract

OBJECTIVE: To identify whether cutoff for sensitivity advertised by three pregnancy tests in urine are compatible to those reported by the manufacturer and to describe their diagnostic performance. METHODS: The urine of a male volunteer was used to dilute recombinant β-hCG at defined concentrations of 0, 6.25, 12.5, 25, 50, and 100 mIU/mL. The tubes containing each of the concentrations were coded and blindly assessed for positivity in three different lots of hCG tests: Strip Test Plus®, BioEasy®, and Visitect Pregnancy®. The sample size was calculated for an alpha error of 5%, with a power of 99%. RESULTS: All three brands, in their three lots analyzed, had 100% of sensitivity for detecting β-hCG, with 100% negative predictive value, using only negative controls and samples with concentrations equal or higher than the test cutoff (n = 180/brand). The accuracy of the tests was 83% (BioEasy®), 84%(Visitect®) and 91% (Strip Test Plus®). Strip Test Plus® had the best positive likelihood ratio (52.5), while Visitect® had the best negative likelihood ratio (zero). CONCLUSION: The three brands have adequate sensitivity for the advertised cutoffs. The Strip Test Plus® test had the best performance to identify urinary concentrations of β-hCG > 12.5 mIU/mL, and consequently, to confirm pregnancy, while Visitect® had the best performance to exclude β-hCG in urine (negative post-test probability: zero).

PMID 22012284