| Test | : | Vitamin B12 (ECLIA) |
| Other Test Request Name | : | • Cyanocobalamin • Cobalamin |
| Test Composition | : | Not applicable |
| Intended Use | : | • For investigation of macrocytic anemia • For work-up of deficiencies seen in megaloblastic anemias • For Assistance in diagnosis of CNS (Central Nervous System) disorders • For evaluation of alcoholism • For evaluation of mal-absorption syndromes |
| Methodology | : | Electrochemiluminescence Immunoassay (ECLIA) |
| Laboratory Section | : | Immunology |
| Special Instructions/Patient Preparations | : | • 8-12 hours fasting. Note: Prolonged fasting is highly discouraged since various metabolic changes associated with starvation may begin to develop. Water intake is acceptable. Note in clinical info if patient drank more than 4 glasses of water during fasting period, ask patient for medical history as this is rather unusual. Note in clinical info in case patient overfasts and insists on proceeding test. Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration. Protect sample from light by wrapping the sample tube with aluminum foil or carbon paper. Send sample to HPD Main lab immediately. NOTE:Put label both on tube and on top of wrapping material to avoid mislabeling and unnecessary exposure of sample to light. |
| Collection/Sample Container | : | Red or Gold tube |
Specimen and Volume Requirement Note:Follow tube manufacturer recommendation. | : | 1-3 mL Serum |
| Alternative Specimen and Volume Requirement | : | 1-3 Plasma (Li- or Na-heparin, K3-EDTA) |
| Specimen Stability | | |
| • Room Temperature (15-25°C) | : | Not specified |
| • Refrigerated Temperature (2-8°C) | : | 2 Days |
| • Freezer Temperature (-20°C) | : | 2 Months (Freeze only once) |
| Transport Temperature | : | Transport specimen at 2°C – 8 °C (with cold packs) |
| Rejection Criteria | : | • Hemolyzed specimen • Markedly lipemic sample • Exceeded sample stability requirement • Quantity not sufficient • Improperly labeled specimen • Improper collection tube used |
| Running Day | : | Tuesday and Friday |
| Cut Off Time | : | Monday to Saturday: 10:00 PM
Sunday: 6:00PM |
| TAT/Releasing of Results | : | ROUTINE (on running days) • 4 hours after receipt of specimen/ arrival of messenger STAT (on running days only) • 2½ hours from extraction/messenger arrival |
| Reference Interval/Result Interpretation | : | 145.00~569.00 pmol/L |
| Limitations/Interferences | : | • Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration. • In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur. • Samples with extremely high total protein concentrations (hyperproteinemia) are not suitable for use in this assay. Hyperproteinemia may be caused by, but not limited to, the following conditions: Lymphoma, bone marrow disorders such as multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), Waldenstrom macroglobulinemia, plasmocytoma, Amyloidosis. Respective samples may lead to the formation of protein gel in the assay cup, which may cause a run abort. The critical total protein concentration is dependent upon the individual sample composition. |
| Frequently Asked Questions (FAQs) | : | Not applicable |
| Related Words/Test | : | Complete Blood Count, Methylmalonic Acid, Homocysteine, B Vitamins, Intrinsic Factor Antibody, Parietal Cell Antibody, Reticulocyte Count, Blood Smear, Folic Acid |