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This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
0.3 mL (Note: This volume does not allow for repeat testing.)
Red-top tube or gel-barrier tube
If a red-top tube is used, transfer separated serum immediately to a plastic transport tube. Avoid hemolysis.
Causes for Rejection
Plasma specimen; hemolysis; improper labeling
Detect folate deficiency; monitor therapy with folate; evaluate megaloblastic and macrocytic anemia; evaluate alcoholic patients and those with prior jejunoileal bypass for morbid obesity or those with intestinal blind-loop syndrome
Folate assays of samples from patients receiving therapy with certain pharmaceuticals (eg, methotrexate or leucovorin), are contraindicated because of the cross-reactivity of folate-binding protein with these compounds.1 Serum samples should not be altered with additives (biocides, antioxidants, or substances possibly changing the pH of the sample) in order to avoid erroneous folate recovery.
Hemolysis may significantly increase folate values due to high concentrations of folate in red blood cells; therefore, hemolyzed samples are not suitable for this assay.1
Samples with extremely high total protein concentrations (eg, patients suffering from Waldenström macroglobulinemia) are not suitable for use in this assay, since they may lead to the formation of protein gel in the assay cup.1
As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes.1 In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur.1 The test contains additives that minimize these effects.
Electrochemiluminescence immunoassay (ECLIA)
Folates are compounds of pteroylglutamic acid (PGA) that function as coenzymes in metabolic reactions involving the transfer of single-carbon units from a donor to a recipient compound. Folate, with vitamin B12, is essential for DNA synthesis, which is required for normal red blood cell maturation.2 Humans obtain folate from dietary sources including fruits, green and leafy vegetables, yeast, and organ meats.3 Folate is absorbed through the small intestine and stored in the liver.
Low folate intake, malabsorption as a result of gastrointestinal diseases, pregnancy, and drugs such as phenytoin are causes of folate deficiency.4 Folate deficiency is also associated with chronic alcoholism.5 Folate and vitamin B12 deficiency impair DNA synthesis, causing macrocytic anemias. These anemias are characterized by abnormal maturation of red blood cell precursors in the bone marrow, the presence of megaloblasts, and decreased red blood cell survival.2
Since both folate and vitamin B12 deficiency can cause macrocytic anemia, appropriate treatment depends on the differential diagnosis of the deficiency. A serum folate concentration <3 ng/mL is considered to represent clinical deficiency by the World Health Organization and numerous subsequent clinical studies.6,7 Serum folate measurement provides an early index of folate status3; however, folate is much more concentrated in red blood cells than in serum so the red blood cell folate measurement more closely reflects tissue stores.5,8 Erythrocytes incorporate folate as they are formed, and levels remain constant throughout the life span of the cell. RBC folate levels are less sensitive to short-term dietary effects than are serum folate levels. Red blood cell folate concentration is considered the most reliable indicator of folate status.3
Low serum folate during pregnancy has been associated with neural tube defects in the fetus.9,10
In the 1990s mandatory increased fortification of enriched cereal-grain products along with the requirement of folate-related health and nutrient content claims on food and dietary supplement products significantly increased the folic acid content of the US food supply.11-13 Several reports have shown that serum folate concentrations have increased in the general US population since these measures were implemented.11-13
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|002014||Folate (Folic Acid), Serum||2284-8||002020||Folate (Folic Acid), Serum||ng/mL||2284-8|