750-P: Afinion HbA1c Dx Point-of-Care Test Is Accurate to Diagnose Diabetes in CLIA-Waived Settings (2024)

FAQs

How accurate is afinion HbA1c? ›

Total error (fingerstick): 2.87–4.75% The POCT evaluated is precise across its measuring range using both fingerstick and venous whole blood. The total error is well under the accepted quality requirement of ≤ 6%.

Immediate point of care HbA1c results for efficient monitoring of glycemic control. The Afinion™ HbA1c assay is a test for quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, used to monitor metabolic control in patients with diabetes.

The Afinion HbA1c measuring range is 4.0-15.0% HbA1c. The HbA1c results are displayed in 0.1% intervals. The hemoglobin measuring range is 6.0-20.0 g/dL.

Test Principle: Afinion™ HbA1c is a fully automated boronate affinity assay. The test Cartridge contains all of the necessary reagents. The sample is collected with the integrated sampling device and the Test Cartridge is placed in the cartridge chamber of the analyzer.

Also, the low sensitivity of HbA1c in the diagnosis of early diabetes, which is approximately 0.5, further limits its usefulness as a diagnostic tool. The high specificity of the test (0.95) makes the HbA1c test unlikely to be a false positive, but it may often provide a result that is falsely negative.

The POC method has a sensitivity of 88.6% and specificity of 96.3% in diagnosing diabetes (Table 1). Conclusions: Per ADA guidelines, the POC method is not recommended to be used to diagnose diabetes. Based on our findings 10.3% of individuals would be missed if one used the POC method to diagnose diabetes.

Point of care A1C methods are small instruments or unitized devices that run single samples. There are four POC, CLIA-waived devices cleared for use in the United States. As CLIA-waived devices, highly trained personnel are not required for operation. All four methods are NGSP certified.

Short assay time in 3 minutes.

POC-A1c presented a mean cost of US$10,503.48 per individual and an effectiveness of 0.35, vs.

103 Hemoglobin too low Consult the Afinion HbA1c Package Insert. 104 Hemoglobin too high Consult the Afinion HbA1c Package Insert. 105 HbA1c too low Consult the Afinion HbA1c Package Insert.

What is the error code 210 on afinion HbA1c? ›

Information code 210 will be displayed and no test result obtained if the Test Cartridge is too cold when used. Do not freeze. The Afinion™ HbA1c Test Cartridges can be stored in unopened foil pouches at room temperature for 90 days.

Afinion™ HbA1c Control

Opened controls are stable for 60 days.

The test that doctors most often rely on to detect a person's risk for prediabetes and type 2 diabetes—the hemoglobin A1c (A1c) blood test—too often delivers a poor reading, thereby missing the diagnosis in nearly three out of four at-risk individuals, according to research presented at the Endocrine Society meeting in ...

Short assay time in 3 minutes.

How accurate is it? While research on these over-the-counter A1C tests is scarce, this 2010 study showed that of 177 people using the kit, more than 93 percent saw their A1C results come back at a range within 13.5 percent of the lab value.

Depending on the machine, a single A1C test can have up to a 0.5% margin of error, which means the “true” value might be 0.5% higher or lower than the measured A1C. For example, if a lab report shows an A1C value of 7.0%, the actual A1C value might range from 6.5% and 7.5%.