What is A1C?

A1C test results are reported as a percentage. A higher percentage indicates higher blood glucose levels in the past 2 to 3 months.

The A1C blood test is used to diagnose diabetes, plan your diabetes treatment, and monitor how well your treatment is working over time. (source)

A normal A1C level is below 5.7%, a level of 5.7% to 6.4% indicates prediabetes, and a level of 6.5% or more indicates diabetes. (source)

The higher the levels, the greater your risk of developing diabetes complications.

The ADA recommends that the goal for most adults with diabetes is an A1C level of less than 7%. However, there’s no one-size-fits-all target. The individual goal will depend on many things, such as your age and other medical conditions. Consult your doctor to set your own individual A1C goal. (source, source)

Unlike the glucose test, the A1C test does not require fasting before having blood drawn.

The OBM rapid A1c test allows a 5-minute A1C test at home using a fingerstick blood sample, offering laboratory-level accuracy.

In 1958, Huisman and Meyering employed chromatographic techniques to isolate hemoglobin A1C from other hemoglobin variants (1). Key achievements in A1C testing to date are summarized below.

Samuel Rahbar initially reported the association between its elevation in diabetes in 1969 (2).

Anthony Cerami, Ronald Koenig, and their team suggested in 1976 using hemoglobin A1C as a marker for monitoring glucose metabolism control in diabetic patients (3).

Commercially available laboratory-based hemoglobin A1C testing became available in 1978.

Point-of-care (POC) hemoglobin A1C testing became available in the 1990s and usage has increased over the last decade.

A committee of international experts recommended A1C testing be used as widely as possible to diagnose diabetes instead of the blood sugar test at the American Diabetes Association’s 69th Scientific Sessions in 2009. (4)

Today, the test is a critical component for diabetes diagnosis, treatment and management (5).

Yes, the HbA1C test and A1C test are the same. The A1C test is also referred to as the hemoglobin A1C test (6) and Hb stands for hemoglobin.

When sugar enters your bloodstream, it attaches to hemoglobin (Hb), a protein in red blood cells. Everyone has some sugar attached to their hemoglobin, but higher blood sugar levels result in more sugar-attached hemoglobin (see image 1), making the blood “stickier” and raising the risk of complications (see image 2). The A1C test measures the percentage of red blood cells with sugar-attached hemoglobin. 

Unlike conventional A1C measurement methods that quantify proteins using reagents, the OBM rapid A1c test employs a novel approach using its patented ‘Micro Electro-Mechanical System.’ This system mimics the microvessels of the human body within a small cartridge. Consequently, the OBM rapid A1c test directly measures how smoothly red blood cells flow and calculates the A1C level based on this flow. (Watch the video)

A recent study by the University of Florida revealed that at-home meters currently sold over the counter (sold under generic pharmacy brands or A1CNow+ brand, a subsidiary of SinoCare International, based out of Hunan, China) are not as accurate as traditional laboratory equipment (9).

OBM rapid A1c achieves the same level of accuracy as traditional laboratory test equipment. The device was designed to use a completely novel testing method (measuring physical properties of red blood cells using microfluidic technology) to overcome accuracy challenges with current at-home A1C tests or POC devices on the market.

See a full comparison of OBM rapid A1c vs. traditional at-home and laboratory testing equipment here.

Hemoglobin variants are one of many factors that can influence an A1C test’s accuracy. This type of variant is most commonly found in patients of Black, South and Southeast Asia, and Mediterranean descent. Measurements for these patient populations may not be entirely accurate (10).

In addition, other factors can affect A1C result accuracy in some ethnic group. For example, the Black population has a higher rate of sickle cell disease, and A1C test result for people with sickle cell disease are significantly inaccurate.

Read more about minority patient groups’ higher risk of developing diabetes and receiving inaccurate A1C readings.

A1C meters can be purchased in-person at most pharmacies and online directly through manufacturers’ websites.

Orange Biomed is currently conducting U.S. clinical trials of OBM rapid A1c and aims to obtain FDA clearances in 2025.

Sign up here to receive updates on U.S. clearance and commercial availability.

Reimbursement information will be released for the OBM rapid A1c system after FDA clearance is received (anticipated for 2025). In the meantime, please contact us with any questions.

(The reimbursement for the OBM rapid A1c At-Home System may vary depending on your insurance plan. Please reach out to your insurer for more detailed guidelines.

Additionally, the OBM rapid A1c At-Home System purchased over the counter is eligible for HSA/FSA reimbursement.)