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10-23-2006, 11:42 PM
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SKNewbie
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Joined on: Oct 2006
Location: Near Phoenix, Arizona
Messages: 5
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Medical Study re: accuracy of OTC pg. tests
I found a great webpage ( http://www.medscape.com/viewarticle/515242_print) that has a study of the major OTC pg. tests, and their respective sensitivity/accuracy. You have to register (free) to read the article, but I will copy and paste the bare bones of it. There is quite a bit of medical jargon in there.
We all know how frustrating it is not knowing if you are pg. and how anxious you are to know yes or no.
I am not advocating any particular brand here, just fyi... the most reliable test with the earliest hcG detection is the according to their test done in Nov. 2005 is the First Response Early Result.
Here is a snippet:
Table 1 summarizes the results of the blind evaluation of seven OTCPTs. The lowest hCG concentration for which all devices (12 of 12) yielded positive results, or the analytical sensitivity, of the OTCPTs varied greatly. The analytical sensitivities were as follows:
First Response Early Result, less than 6.3 mIU/mL (we report less than 6.3 mIU/mL rather than 6.3 because we measured no lower concentrations of hCG, sensitivity may be lower)
Clearblue Easy Earliest Results, 25 mIU/mL
CVS One Step, Eckerd One Step, and E.P.T., 100 mIU/mL
AccuClear and Fact Plus Select, greater than 100 mIU/mL (we report greater than 100 mIU/mL because all devices tested were not positive at 100 mIU/mL, indicating an analytical sensitivity equivalent to a higher concentration of hCG)
Devices from three products failed to work or were faulty ( Table 1 ). These products failed to show a band in the control window confirming that the device was working. This occurred in 1 (1%) of the 69 AccuClear devices evaluated, 2 (3%) of the 70 CVS One Step devices evaluated, and 5 (8%) of the 66 E.P.T. devices evaluated.
Discussion
In this study, OTCPTs varied greatly in sensitivity, performance, and clarity of result.
First Response Early Result stood out, having an analytical sensitivity of less than 6.3 mIU/mL. This product can be expected to detect more than 95% of pregnancies on the first day of a missed menstrual period, and evaluators had 100% confidence in positive and negative results using this product. Scantibodies Laboratories Inc., the manufacturer, produces two additional devices, Answer and Answer Quick & Simple, that appear to be similar in design and manufacture to First Response Early Result.[3]
Clearblue Easy Earliest Results was the second most sensitive test in this study, having an analytical sensitivity of 25 mIU/mL. This product would likely detect 80% of pregnancies on the first day of the missed period, and evaluators had 100% confidence in its positive results and 67% in negative results. Clear Plan Easy is a similar product made by the same manufacturers.[3] A digital version of Clearblue Easy Earliest Results has also been introduced.[14] With the digital product the presence of a band is electronically read, rather than a blue line forming that must be visually judged by the user. Consumers may more easily interpret the digital results,[14] and this would increase confidence in negative results, which would address an issue reported here. A digital product may not, however, resolve the problem of lower sensitivity reported in this study.
The bulk of products we evaluated (five of the seven) had analytical sensitivities of 100 mIU/mL or greater. These products would likely detect 16% of pregnancies or fewer on the first day of the missed period, and evaluators had only 22% to 57% confidence in positive results and 26% to 85% confidence in negative results. Furthermore, three of these five products—AccuClear, CVS One Step, and E.P.T.—had clear indications of technical or design problems in which devices failed to work or were faulty. Three of these five products, including two of the products (Eckerd One Step, CVS One Step, and AccuClear) that failed to work properly, were representative of the numerous similar branded products made by Inverness Medical Innovations Inc.[3] These include the Inverness Medical Early, Rite Aid One Step, Savon Osco One Step, Target Brand, Walgreens One Step, Family Dollar One Step, and several others.[3] The other two lower-sensitivity, lower-confidence products, Fact Plus Select and E.P.T., are made by Ross Products and Pfizer Consumer Healthcare, which also makes other similar products, Fact Plus Pro and Confirm.
I found this test intersting, and if I have need to test myself, this will help with the decision as to what test to buy.
Oh, btw, for standarization of urine, they used urine from 5 non-pg women and added their own hcG hormones in different degrees of strength to obtain a even result across the board.
__________________
Mom to
Connor, 11/2/94
and Ayla, 4/1/01
Happy wife to Joseph
My "baby" girl-
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