Waived HgbA1c testing options

The Director of our Home Health department has asked me for information about HgbA1c tests that her nurses could use on home visits.  The only POC test I'm familiar with is the Afinion, which we use at 2 of our hospital owned practices.  Can anyone give me suggestions for A1C tests that are CLIA waived that would be suitable for transporting to and from patient's homes?

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Look up the A1C now plus. Can only be used for monitoring diabetics and not for screening or diagnostic purposes. It’s the only portable one I am aware of.

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by FDA regs, no point of care test is allowed to be used in a screening situation.  All POC A1c are to be used in a monitoring and management capacity only.

may be portable, but since its inception, the accuracy and precision is not what most clinicians accept for the management of patients with diabetes. 

These would not be used for screening purposes, only on previously diagnosed diabetics.  Thanks for the information.

 

Can anyone who either uses the A1CNow+ or knows about it tell me which external controls you use?

 

We use Biorad Lyphocheck Diabetes control

A1C Now+ has been an excellent kit for our needs. We have them in 3 of our physician practices.

  • Ran a study of the A1C Now kit vs. the main lab Tosho 8.0 and validated the manufacturers sensitivity and specificity.
  • Caveats: Well trained staff is a must!! & don't move the meter while testing!
  • Don't drop the meter that comes with the kit, it breaks even if from just a few inches from a hard surface.  They can't be replaced and the whole kit has to be trashed.
  • Can only be used a diabetic patients.
  • MUST be QC'd new lot, new shipment same lot number and every 30 days open.

We use NOVA-One diagnostics controls for our A1C Now+ kits. It is a good product and has a 6 month open stability at 2-8C. 

Thanks for the QC info.

 

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