당뇨병 감시와 진단을 위한 Point-of-care A1C testing

ADA 2023 추가 내용1

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당뇨병 감시와 진단을 위해 Point-of-care A1C testing을 시행하고 device는 FDA 승인된 것으로 제한합니다.

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Point-of-care A1C testing for diabetes screening and diagnosis should be restricted to U.S. Food and Drug Administration–approved devices at laboratories proficient in performing testing of moderate complexity or higher by trained personnel. B

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The A1C test should be performed using a method that is certified by the NGSP (ngsp.org) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay. Point-of-care A1C assays may be NGSP certified and cleared by the U.S. Food and Drug Administration (FDA) for use in monitoring glycemic control in people with diabetes in both Clinical Laboratory Improvement Amendments (CLIA)-regulated and CLIA-waived settings. FDA-approved point-of-care A1C testing can be used in laboratories or sites that are CLIA certified, are inspected, and meet the CLIA quality standards. These standards include specified personnel requirements (including documented annual competency assessments) and participation three times per year in an approved proficiency testing program (29–32). As discussed in Section 6, “Glycemic Targets,” point-of-care A1C assays may be more generally applied for assessment of glycemic stability in the clinic.

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The A1C test, with a diagnostic threshold of ≥6.5% (48 mmol/mol), diagnoses only 30% of the diabetes cases identified collectively using A1C, FPG, or 2-h PG, according to National Health and Nutrition Examination Survey (NHANES) data (33). Despite these limitations with A1C, in 2009, the International Expert Committee added A1C to the diagnostic criteria with the goal of increased screening (21).

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★ 참고로 1차 클리닉에서 많이 사용되는 아피니온 기기입니다.

 

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