Strips of Hope: Accuracy of Home Pregnancy Tests and New Developments.

@article{Gnoth2014StripsOH,
  title={Strips of Hope: Accuracy of Home Pregnancy Tests and New Developments.},
  author={Christian Gnoth and S. Johnson},
  journal={Geburtshilfe und Frauenheilkunde},
  year={2014},
  volume={74 7},
  pages={
          661-669
        }
}
The first home pregnancy test was introduced in 1976. Since then, pregnancy tests have become the most common diagnostic assay used at home. Pregnancy tests use antibodies to detect human chorionic gonadotropin (hCG). It is an ideal marker of pregnancy since it rises rapidly and consistently in early pregnancy and can be detected in urine. The most advanced home pregnancy test currently available assesses the level of hCG found in urine and claims to provide women with reliable results within… Expand
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References

SHOWING 1-10 OF 46 REFERENCES
Detection of early pregnancy forms of human chorionic gonadotropin by home pregnancy test devices.
TLDR
H-hCG is the principal hCG-related molecule in pregnancy urine in the 2 weeks following the missed menses and the variation in analytical detection limits appears contradictory to the common claim for all devices of >99% detection of pregnancy on the first day of the missing menses or earlier. Expand
Accuracy of home pregnancy tests at the time of missed menses.
TLDR
The utility of home pregnancy tests (HPTs) is questioned and Clinicians need to be aware of the limitations of current HPT brands. Expand
Comparison of accuracy and certainty of results of six home pregnancy tests available over-the-counter
TLDR
The Clearblue Digital Pregnancy Test (CBDPT) was significantly better in terms of accuracy and certainty than non-digital OTC HPTs tested at a low hCG concentration and demonstrates that a digital reading offers significant benefits to the consumer over traditional non- digital tests. Expand
Home pregnancy test compared to standard-of-care ultrasound dating in the assessment of pregnancy duration
TLDR
The home pregnancy test provides a significantly high level of agreement with standard-of-care ultrasound when assessing pregnancy duration in a real-life, observational setting which closely mirrors daily clinical practice. Expand
Reliability and feasibility of pregnancy home-use tests: laboratory validation and diagnostic evaluation by 638 volunteers.
TLDR
It is concluded that pregnancy home-use tests should be subjected to rigorous analytical controls and evaluated by a panel of potential users before being released on the market. Expand
Accuracy of a home-based device for giving an early estimate of pregnancy duration compared with reference methods.
TLDR
This home pregnancy test provides an accurate estimation of pregnancy duration in weeks categories, 1-2, 2-3, 3+ weeks since ovulation, thereby showing utility in dating pregnancy. Expand
Comparison of home pregnancy test with weeks estimator and ultrasound crown rump measurement to predict delivery date
TLDR
A new urine pregnancy test, Clearblue® Advanced Pregnancy Test with Weeks Estimator (CAPT), is available in the USA, which as well as determining pregnancy status also estimates the number of weeks since ovulation for women testing pregnant. Expand
Diagnostic considerations in the measurement of human chorionic gonadotropin in aging women.
TLDR
Serum hCG concentrations in nonpregnant women increased with the age of the women and the use of serum follicle-stimulating hormone (FSH) measurements as an aid to interpreting higher than expected ("positive") hCG results was investigated. Expand
Diagnostic efficiency of home pregnancy test kits. A meta-analysis.
TLDR
The diagnostic efficiency of home pregnancy test (HPT) kits is greatly affected by characteristics of the users and it is suggested that manufacturers of HPT kits publish results of trials in actual patients before marketing them to the general public. Expand
Symptomatic Patients With an Early Viable Intrauterine Pregnancy: hCG Curves Redefined
TLDR
The minimal rise in serial hCG values for women with a viable intrauterine pregnancy is “slower” than previously reported, suggesting that intervention to diagnosis and treat an abnormal gestation should be more conservative. Expand
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