Bayer A1C NOW trial test

[Ronin]

Hi Everyone!

You may already know me from other areas of DF. Looking at my signature block you know that I love numbers. I try to do an HbA1c monthly as it is a weighted moving average that is said to cover 90 days (the "average" life of a red blood cell) however, the normal blood population is skewed heavily towards the most current four weeks representing at least 50% of the total population. As an aerobic athlete I know that my red cell population would be skewed because I kill those cells of in heavy exercise.

So, I've tried a number of home tests as the VA only gives me one A1c every six months. Today I tried the Bayer A1C NOW kit.

It was very straight forward and the instructions are very well written -- they even enclose a mini-DVD that shows you step-by-step how to do the test.

Results -- 5.1% which is pretty much consistent with previous months. I know there is some controversy about the accuracy of this kit but it seems to have worked for me. I won't have a lab comparison until April though.

[ShottleBop]

From Dave Mendosa's most recent SharePost:

Bayer Diabetes Care's A1CNow+ monitor for us to test our A1C level at home carries the highest certificate of accuracy. As I wrote here in June, the NGSP (formerly the National Glycohemoglobin Standardization Program) certified this device as having documented traceability to the Diabetes Control and Complications Trial reference method, which established relationships between A1C levels and risk for complications of diabetes. The DCCT method is the gold standard for reliable A1C testing.

So I was surprised to read an article in the journal Clinical Chemistry indicating that this was one of the A1C testing devices that didn't meet "the general accepted analytical performance criteria." Two Dutch researchers led by Erna Lenters-Westra reported that the local distributor in the Netherlands of the A1CNow+ Bayer "concluded that the EP-10 [protocol] outcome data did not warrant progression" to the two other protocols the study used.

But the key sentence -- buried in the full-text of the study and missing from the online abstract -- is this, "The bias found with the EP-10 protocol of the A1CNow was probably due to EDTA interference problems."

I had to ask Bayer representatives what all this means. This is what the company told me:

"Bayer has reviewed the Lenters-Westra study published in Clinical Chemistry that used Bayer Diabetes Care's A1CNow+® monitor as part of their evaluation," the company wrote back. "Bayer believes that the results that the study authors obtained did not accurately capture the proven performance of the A1CNow+ device due to use outside the manufacturer's specifications [emphasis added].

"The A1CNow+ Product Insert states that A1CNow+ may be used with either fingerstick (capillary) or venous (heparin-anticoagulated) whole blood samples. When used according to the product insert, the results showed that the accuracy of A1CNow+ with fingerstick samples was, on average, 99%. The results showed that accuracy with venous sampling was, on average, 99.7%. Utilizing other anticoagulants, such as EDTA, with the A1CNow+ device will often result in a negative bias, thus affecting the accuracy of the A1C results obtained [emphasis added]. According to the Clinical Chemistry article, the Lenters-Westra study used EDTA anticoagulant."

This shows to me that studies are not always what they seem to be on the surface and that we shouldn't jump to conclusions when we have only the abstract of a study. None of the other A1C testing devices that the study evaluated are available for home use, although a few mail-in kits that the study did not evaluate are on the market. The A1CNow+ remains my favorite.

[goldenbo]

I tried the Bayer A1c Now on Monday night - result was 5.9. I had bloodwork done the following morning at the lab, and the A1c was 6.8. Although I was bummed by the lab result, I know that to be the accurate one as it is what I was expecting based on self-monitoring. I will be trying it again when I'm due again for bloodwork in case I did something wrong. However, I was disappointed it wasn't a much closer result.

[raffi]

I took the home test the same morning I had my labs done. I got 5.3 and the labs came back 5.7. It was in the ballpark, but not as close as I hoped.

[Ronin]

ShottleBop, et al.,

Thanks for the update. I looked at the other devices used in the test and discovered that all of the other devices were specifically made for use in MD office settings and most had other functions like printouts and the ability to enter patient data, link to computer records and other functions.

While the A1C Now isn't perfect it is a step in the right direction by being an affordable home test that is reasonably accurate and will hopefully get better over time. Actually Bayer worked with Siemens on one of the MD office units that passed the test so my guess is that some of the celectronics are the same in both machines.

I can remember the "bad old days" when my father had to use urine sticks and try to figure out which color was closest to his actual values. We've come a very long way.

[ShottleBop]

Now that the Bayer A1cNow home tester 2-pack is becoming available at retail outlets, I picked one up at the Rite-Aid down the block on my way to lunch. Just got back and tested: 5.0 (That correlates to an average BG of 97. My meter average for the past 3 months is 91 (last 30 days 89), so I was hoping for under 5, but (i) the 5 is within tolerances, and (ii) my lab-tested A1cs have always measured .3 - .4 higher than my meter averages would indicate. So I'm not too surprised.)

I go in sometime next week for a new lab A1c; we'll see how things match up.

[poodlebone]

I should be getting one of these soon from eBay. I bid on & won a lot consisting of several Contour meters and one of the A1c meters. I typically only see my CDE twice a year. While my A1c is always in the same general range I think having the home kit will be useful. I see my PCP only if I really, really, really have to.

I saw my CDE in January and don't plan on seeing her again until late Summer/early Fall. I think the Bayer kit has two tests so I'll do one in April and then the other when I make an appointment with my CDE or PCP and have lab work done.

Nice thing about this is I don't have to send the results, along with my personal info, to the NYC DOH as labs here are required to do.

[HuskerMychal]

I have never tried the Bayer NOW one but I have used the Reli-On one from Walfart. Found it to be very close for the price. within .2 last 3 times I tested and it was .2 higher so my labs were a good suprise

[plattb1]

So, I tried the Bayer A1c at home test kit & was very disappointed in the results. It showed 5.6 on Monday - my doctor's lab showed 6.3 on Thursday. Not close at all.

I'm not sure how useful this tool really is. It certainly doesn't seem to approach the 99% accuracy rate the company reports for fingerstick sample - based on my experience & that of the experiences I have read on this forum & others.

[Big Daddy Kool]

It may vary by user.

So, I tried the Bayer A1c at home test kit & was very disappointed in the results. It showed 5.6 on Monday - my doctor's lab showed 6.3 on Thursday. Not close at all.

I'm not sure how useful this tool really is. It certainly doesn't seem to approach the 99% accuracy rate the company reports for fingerstick sample - based on my experience & that of the experiences I have read on this forum & others.

[plattb1]

It may vary by user.

Oh, was that a kind way of saying, "Operator error"?

Just kidding. But, I DID follow the directions precisely. And, it's pretty user-friendly.

[Big Daddy Kool]

No, just that the success of the A1c home test seems to vary per user. I've read where some users results were either spot on or very close and others were well off.

Oh, was that a kind way of saying, "Operator error"?

Just kidding. But, I DID follow the directions precisely. And, it's pretty user-friendly.

[ShottleBop]

I've read elsewhere that shipping conditions can affect the accuracy of the test.

Meanwhile, my blood tests turned out not to include an A1c, so I'm going to go with the 5.0 the Bayer A1cNow gave me--so far, it's always run high vs. the lab test.

[Freedom&Light]

I used this one and got 7.2%, which led me to go to the doctor and get the eventual diagnosis of T2. The A1c run by the lab 3 days later came out to 7.7%. While it may not be exactly the same, it was close and caused me to spring into action. I'm glad it's there!

[TommyC1]

I tried the A1C Now for my last one. I gave me the 6.2 on my sig. I was expecting higher but it still made me feel pretty good.
I'm going to take the second test when I see the Endo in May.
It will be interesting to see how his results compare to this one.