Diabetes Risk–Asymptomatic Adults

CPT: 82947; 83036
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Synonyms

  • Diabetes Risk Assessment
  • Prediabetes Screen

Special Instructions

FPG: It is critical that samples for plasma glucose be spun soon after collection. SST tubes should be allowed to clot for about 30 minutes and centrifuged within 45 minutes of collection. If glucose samples are not centrifuged promptly, glucose levels will decrease factitiously.


Expected Turnaround Time

Within 1 day


Related Documents

For more information, please view the literature below.

Prediabetes Clinician Booklet

Prediabetes Q&A for Clinicians


Specimen Requirements


Specimen

Whole blood and plasma


Volume

4 mL whole blood and entire collection of plasma


Minimum Volume

4 mL whole blood and 0.5 mL plasma


Container

Hemoglobin A1c: lavender-top (EDTA) tube; green-top (lithium heparin) tube; or gray-top (sodium fluoride) tube

Glucose, Plasma: gray-top (sodium fluoride) tube or green-top (lithium heparin) tube


Collection

Hemoglobin A1c: The usual precautions in the collection of venipuncture samples should be observed. The sample must be free of clots. Samples with any hematocrit disorders can lead to erroneous results. Send the entire tube to the laboratory.

FPG: Label specimen as plasma. Mix well.


Storage Instructions

Maintain A1c and FPG specimens at room temperature.


Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3


Patient Preparation

A1c: None

FPG: Blood should be drawn in the morning after an overnight fast (no caloric intake for at least eight hours), during which time the individual may consume water.


Causes for Rejection

A1c: clotted specimen; gross hemolysis

FPG: gross hemolysis; improper labeling


Test Details


Use

Screen for prediabetes and diabetes in asymptomatic adults


Limitations

Hemoglobin A1c: Any cause of shortened erythrocyte survival will reduce exposure of erythrocytes to glucose with a consequent decrease in Hb A1c (%). Causes of shortened erythrocyte lifetime might be hemolytic anemia or other other hemolytic diseases, homozygous sickle cell trait, pregnancy, or recent significant or chronic blood loss. Glycated Hb F (fetal hemoglobin) is not detected as it does not contain the glycated beta chain that characterizes Hb A1c. Specimens containing high amounts of Hb F(>10%) may result in lower than expected Hb A1c.


Methodology

A1c: Roche Tina-Quant Hemoglobin A1c which is NGSP certified and standardized to the DCCT reference assay.

Plasma glucose: enzymatic


Reference Interval

Hemoglobin (Hb) A1c

(%)

Fasting Plasma Glucose

mg/dL

Diabetes

>6.4

>125

Prediabetes

5.7 to 6.4

100 to 125

Glycemic Control for Adults with Diabetes

<7.0

N/A

Normal

4.8 to 5.6

65-99

For selected individual patients, providers might reasonably suggest even lower A1c goals than the general goal of <7%, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Such patients might include those with short duration of diabetes, long life expectancy, and no significant CVD. Conversely, less‐stringent A1c goals than the general goal of <7% may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, and extensive comorbid conditions and those with longstanding diabetes in whom the general goal is difficult to attain.


Additional Information

Screening for prediabetes and type 2 diabetes is important in all patients 45 years of age and older and others (see below) because both are common and often have a long, pre-symptomatic stage. Additionally, both conditions meet criteria for which early detection is appropriate and advantageous, especially since simple tests are readily available and effective interventions exist.

Current American Diabetes Association (ADA) testing criteria for prediabetes and diabetes in asymptomatic adults includes:

• All patients 45 years of age or older

• Consider in overweight or obese (BMI greater than or equal to 25 kg/m² or greater than or equal to 23 kg/m² in Asian Americans) adults of any age with one or more of the following risk factors:

- 1st degree relative with diabetes

- High risk race/ethnicity (eg, African American, Latino, Native American, Asian American, Pacific Islander)

- History of CVD

- Hypertension or on therapy for hypertension

- HDL‐C value < 35 mg/dL and/or triglyceride value > 250 mg/dL

- Polycystic ovary syndrome

- Physical inactivity

- Conditions associated with insulin resistance (eg, severe obesity, acanthosis nigrans)

Fasting plasma glucose (FPG), plasma glucose after 75-gram oral glucose tolerance test (OGTT) and hemoglobin A1c (A1c) are equally appropriate assays for prediabetes and diabetes screening. 2018 ADA standards of medical care mandate that two abnormal test results (ie, both FPG and A1c) are needed for diagnosis unless there is a clear clinical diagnosis (ie, random plasma glucose greater than or equal to 200 mg/dL). A single abnormal test can be repeated using a new blood sample for confirmation.

Hemoglobin A1c: Factors such as duration of diabetes, adherence to therapy, and age of patient should also be considered in assessing the degree of blood glucose control.

FPG: Recent evidence revealed diurnal variation in FPG, with mean FPG higher in the morning than in the afternoon, indicating that many cases of undiagnosed diabetes would be missed in patients seen in the afternoon. Glucose concentrations decrease ex vivo with time in whole blood because of glycolysis. For this reason, samples should be centrifuged promptly. The rate of glycolysis, reported to average 5% to 7% [approximately 0.6 mmol/L (10 mg/dL)] per hour, varies with the glucose concentration, temperature, white blood cell count, and other factors. Glycolysis can be attenuated by inhibition of enolase with sodium fluoride (2.5 mg fluoride/mL of blood) or, less commonly, lithium iodoacetate (0.5 mg/mL of blood). These reagents can be used alone or, more commonly, with anticoagulants such as potassium oxalate, EDTA, citrate, or lithium heparin. Although fluoride maintains long-term glucose stability, the rate of decline of glucose in the first hour after sample collection in tubes with and without fluoride is virtually identical. (Note that leukocytosis will increase glycolysis even in the presence of fluoride if the white cell count is very high). After four hours, the glucose concentration is stable in whole blood for 72 hours at room temperature in the presence of fluoride. In separated, non-hemolyzed, sterile serum without fluoride, the glucose concentration is stable for eight hours at 25°C and 72 hours at 4°C.

Glucose can be measured in serum, or plasma, but plasma is recommended for diagnosis. Glucose concentrations in heparinized plasma are reported to be 5% lower than in serum. The reasons for the latter difference are not apparent, but may be attributable to the shift in fluid from erythrocytes to plasma caused by anticoagulants. The glucose concentrations during an OGTT in capillary blood are significantly higher than those in venous blood [mean of 1.7 mmol/L (30 mg/dL), equivalent to 20% to 25%], but the mean difference in fasting samples is only 0.1 mmol/L (2 mg/dL).

Although methods for glucose analysis exhibit low imprecision at the diagnostic decision limits of 7.0 mmol/L [(126 mg/dL), fasting] and 11.1 mmol/L [(200 mg/dL), post-glucose load], the relatively large intraindividual biological variability (Coefficients of variation of approximately 5% to 7%) may produce classification errors.


References

American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16.25537714
American Diabetes Association. Summary of revisions for the 2010 Clinical Practice Recommendations. Diabetes Care. 2010 Jan;33 Suppl 1:S3.20042773
Berstrom RW, Kelley JR, Ward WK. Fetal hemoglobin alters hemoglobin A1c measurements. Ann Intern Med. 1991 Oct 15;115(8):656.1716431
Fairbanks VF, Zimmerman BR. Measurement of glycosylated hemoglobin by affinity chromatography. Mayo Clin Proc. 1983 Nov;58(11):770-773.6632974
Holt GS, Wofford JL, Velez R. Hemoglobinopathies affect hemoglobin A1c measurement. Ann Intern Med. 1991 Jul 1;115(1):68-69.1760005
Krauss JS, Khankhanian NK. HPLC determination of hemoglobin A1c in the presence of the fast hemoglobin I-Philadelphia. Clin Chem. 1989 Mar;35(3):494-495.2920422
Sacks D, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem. 2002 Mar;48(3):436-472.11861436

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
090400 Diabetes Risk Asymptom Adults 001818 Glucose, Plasma mg/dL 1558-6
090400 Diabetes Risk Asymptom Adults 001481 Hemoglobin A1c % 4548-4

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