Anaemia
LIAISON® Vitamin B12 A complete automated assay for aid in the diagnosis and treatment of anaemic diseases
FOR OUTSIDE THE US AND CANADA ONLY Anaemia LIAISON® Vitamin B12 Vitamin B12 (cobalamin) is a water-soluble vitamin that is crucial to normal neurologic function, red blood cell production and DNA synthesis. The vitamin is absorbed from the food in the small intestine as complex B12-Intrinsic Factor. Dietary deficiency, intestinal malabsorption, autoimmune disease can lead to vitamin B12 deficiency that can turn into megaloblastic anaemia. Affected patients may experience weakness, irritability, jaundice, cognitive impairment. Vitamin B12 is the initial test to perform in case of megaloblastic anaemia together with folate, in order to assess the causes of megaloblastic anaemia and establish the right treatment.
Assay Characteristics
Method Competitive Time to first result 33 minutes Intrinsic Factor to Vitamin B12 Solid Phase / Conjugate isoluminol derivative Integral on board stability 42 days Sample Volume 100 µL Calibration stability 21 days Dynamic range: 55 – 1500 pg/mL
SENSITIVE Limit of Detection (LoD): 51.2 pg/mL Limit of Blank (LoB): 38.7 pg/mL Limit of Quantification (LoQ): 55 pg/mL
Method Comparison Scatter Plot with Passing & Bablok Fit A total of 156 (type serum) samples 1 00 spanning the assay range, were tested by the LIAISON® Vitamin B12 and by another commercially available method 1200 following CLSI EP9-A3, and yielded the Identity Data
Passing Bablo (I) fit following Passing & Bablok regression analysis: 800 (5 3 0 9 ) B12 (pg/mL) LIAISON® Vitamin B12 = 0.97 (Reference
Method) + 5.4; R = 0.985. 400
0 0 400 800 1200 1 00 B12 (pg/mL)
Ordering Information LIAISON® Vitamin B12 (Code 318320) LIAISON® Vitamin B12 Control Set (Code 318321) LIAISON® Endocrinology Diluent (Code 319133)
AVAILABLE ON Product availability subject to required regulatory approval M0870004357 05/19
DiaSorin S.p.A. Via Crescentino 13040 Saluggia (VC) - Italy Tel. +39.0161.487526 Fax: +39.0161.487670 www.diasorin.com E-mail: [email protected]