Clear blue digital pregnancy test hcg sensitivity

Clearblue Digital Ultra Early Pregnancy Test, 2 Digital Tests

Clearblue Digital Ultra Early Pregnancy Test kit combines ultra-sensitive early detection of the pregnancy hormone with ultra clear digital results in words. Our most sensitive digital pregnancy test can be used up to six days before your missed period. *78% of pregnant results can be detected 6 days before your missed period (which is 5 days before you expect your period).

Test sensitivity is 10mIU/ml. Testing is made easy by an extra wide tip and our unique stop light feature, which flashes to tell you when you have sampled enough urine. Plus our Floodguard Technology helps to dramatically reduce reported user error (data on file).

Once the test is running, the Smart Countdown will appear on screen to reassure you the test is progressing, counting down to your clear digital result in words, which will appear on screen within 1-5 minutes. Like all Clearblue Pregnancy Tests, Digital Ultra Early is over 99% accurate at detecting pregnancy when used from the day you expect your period. 

For more information visit our website: www.clearblue.com

•No brand is more accurate: over 99% accurate from the day you expect your period
•Ultra sensitive detection of hCG (10mIU/ml)
•Ultra early results 6 days before your missed period*
•Ultra clear results in words for more trust in your early result – no faint lines
•No.1 brand most recommended in a survey of doctors in the UK (data on file)
•Ultra easy to use – with unique stop light, wide tip, FloodguardTM Technology, Smart Countdown to result

Hazards and Cautions

Please read the enclosed leaflet before use.

For self-testing at home. For in vitro diagnostic use only. Do not reuse.

Keep out of the sight and reach of children.

Storage

Store between 2°- 30°C.

Ingredients

2 test sticks

Comparative Study

. 2005 Sep-Oct;45(5):608-15.

doi: 10.1331/1544345055001391.

Affiliations

  • PMID: 16295647
  • DOI: 10.1331/1544345055001391

Comparative Study

Sensitivity of over-the-counter pregnancy tests: comparison of utility and marketing messages

Laurence A Cole et al. J Am Pharm Assoc (2003). 2005 Sep-Oct.

Abstract

Objective: To determine the sensitivity of seven over-the-counter pregnancy tests (OTC-PTs) using urine containing a mixture of human chorionic gonadotropin (hCG)-related molecules as found on the first day of missed menstrual period.

Design: Blinded in vitro sensitivity analysis.

Setting: Medical school laboratory.

Participants: None.

Interventions: Urine was tested with OTC-PT devices at titers of 100, 50, 25, 12.5, 6.3, and 0 mIU/mL hCG immunoreactivity, and laboratory workers rated their confidence in the test result based on whether the test result was a clear, sharp, and unquestionable band in the test window.

Main outcome measures: Analytical sensitivity, defined as the urine concentration at which all OTC-PTs tested gave a positive result regardless of operator confidence score; clinical sensitivity of OTC-PTs, defined as the proportion of pregnancies likely to be detected on the first day of a missed period and calculated from the analytical sensitivity and a recently published regression curve for total urine hCG immunoreactivity in 25 urine samples from this period of gestation; percentage of tested devices showing a band in the test window at a specific hCG concentration measured devices positive; percentage faulty devices, defined as the proportion of tested devices failing to yield a band in the control window; and confidence score, determined from operator ratings for each device at each concentration of hCG.

Results: First Response Early Result had an analytical sensitivity of 6.3 mIU/mL, which was estimated to detect greater than 95% of pregnancies on the day of missed period. The sensitivity of Clearblue Easy Earliest Results was 25 mIU/mL, which indicated detection of 80% of pregnancies. The sensitivity of the five other products was 100 mIU/mL or greater, indicating detection of 16% or less of pregnancies. Three of these last products included faulty devices.

Conclusion: Universal claims for OTC-PTs of more than 99% laboratory accuracy and use as early as the first day of missed period, while cleared for use by the U.S. Food and Drug Administration, are ambiguous and inappropriate for many products, according to these data. The majority of products tested were found to detect only a small percentage of pregnancies on the first day of a missed menstrual period. Until more data become available on the actual clinical sensitivity of these products, pharmacists should advise consumers to be cautious in interpreting test results.

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Do digital pregnancy tests require more hCG?

Generally, most dye tests detect hCG in urine at levels between 25 mIU/mL and 50 mIU/mL. Digital tests, on the other hand, are less sensitive and may require more hCG — which is why you should wait until you've actually missed your period to try this type of test.

How sensitive are Clearblue Digital tests?

The test is over 99% accurate from the day of the expected period8. 71% of pregnancies can be detected 6 days before the missed period (5 days before the expected period). The Clearblue Rapid Detection Pregnancy Test is over 99% accurate at detecting pregnancy hormone and is also easy to use.

How sensitive is Clearblue Digital with weeks?

The Weeks Indicator is 93% accurate in telling when you conceived when compared to time since ovulation. A published study comparing dating by Weeks Indicator with ultrasound (11-13 weeks) standard of care found that results agreed 97% of the time*.