August 2018 Product Focus: Vitamin D

July 24, 2018

Access 25(OH) Vitamin D Total Assay

Access 25(OH) Vitamin D Total Assay delivers fast, accurate assessment of bone health to help physicians with making therapeutic decisions. The assay aligns with Ghent University 25(OH) standard for vitamin D measurement. It detects both 25(OH) vitamin D2 and 25(OH) vitamin D3, eliminating the need to run multiple tests. In addition, the assay’s reagent pack design preserves reagent integrity to help provide greater storage flexibility. The Access 25(OH) Vitamin D Total Assay offers standardized reagents for all laboratories in the network, whether they use high- or low-volume analyzers. Beckman Coulter

Lumipulse G 25-OH Vitamin D Assay

Lumipulse G 25-OH Vitamin D Assay is a VDSCP-certified Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) and other hydroxylated vitamin D metabolites on the LUMIPULSE G System. The novel sandwich assay is capable of equimolar measurement of total 25-OH vitamin D2 and D3. An assayed tri-level Vitamin D Control set containing both 25-OH vitamin D2 and 25-OH vitamin D3 is also available. Fujirebio

EZ Vitamin D Assay

Diazyme’s EZ Vitamin D Assay is a 2-reagent, latex-enhanced immunoturbidimetric assay for use on general clinical chemistry analyzers. This new Vitamin D assay is liquid-stable, allowing many clinical laboratories to run the EZ Vitamin D test in-house, at a cost-effective price, without the need for special instrumentation. The EZ Vitamin D Assay is fully automated, requiring no sample pre-treatment or pre-dilution steps, and recognizes both 25-OH Vitamin D2 and D3 equally. Diazyme’s EZ Vitamin D assay ensures high assay throughput, precision CV of <10%, and a wide linear range from 7.6 to 147.8 ng/mL. The assay is FDA-cleared and CE-marked, with results correlating to the LC-MS/ MS method. The EZ Vitamin D Assay is also distributed by Carolina Liquid Chemistries Corporation. Diazyme

Complete D 25-OH Vitamin D Control

Complete D 25-OH Vitamin D Control now features values for LOCI Vitamin D Total Assay on the Siemens Dimension EXL. It is compatible, without the need for dilution, on major immunoassay platforms, including Roche Cobas e411/Elecsys, Ortho Vitros ECi, Siemens Centaur XP, Diasorin Liaison, Abbott Architect, and Beckman Access 2. Values are also provided for LC-MS/MS, including reference methods JCTLM #C8RMP3/4. This 2-level, ready-to-use, human serum-based liquid control is traceable to the NIST standard SRM 972a and features 3-years refrigerated shelf-life from date of manufacture, extended open vial stability of 12-months at 2ºC–8ºC, and 1-month at room temperature. Quantimetrix

25-OH Vitamin D ELISA

The FDA-cleared 25-OH Vitamin D ELISA from EUROIMMUN provides fast and reliable determination of the vitamin D level in humans. The assay is based on a monoclonal antibody which is 100% specific to vitamin D2 and D3. The results show a high level of concordance with those of the LC/MS-MS reference method and excellent correlation with target values in the Vitamin D External Quality Assessment Scheme (DEQAS). The ELISA procedure is simple, cost-effective, and fast, requiring less than 3 hours from sample to result, due to enhanced analyte release and incubation in a single step. This assay has been validated to perform on many different ELISA processors, including EUROIMMUN’s EUROLabWorkstation ELISA—processing up to 15 microplates and around 800 samples in a single worklist. EUROIMMUN

LIAISON 25 OH Vitamin D TOTAL Assay

The LIAISON 25 OH Vitamin D TOTAL Assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of 25-hydroxyvitamin D. This is a fully automated assay for the direct measurement of 25-OH vitamin D in human serum. The test detects both 25-OH vitamin D2 and D3 metabolites for a total estimation of circulating 25-OH vitamin D in the body. Biotin does not interfere with the assay. The time to first result is 35 minutes. The LIAISON XL analyzer throughput is 170 tests/hour. The assay met the VDSCP requirements for four consecutive years without changes to the assay or its calibration. Diasorin

FastPack IP Vitamin D Immunoassay Kit

The FastPack System is a fully automated immunoassay analyzer designed to deliver accurate test results (Vitamin D; TSH; FT4; PSA; Testosterone & hCG) with the push of a button in less than 12 minutes. The FastPack IP Vitamin D Immunoassay Kit is for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. Since vitamin D deficiency is the most common nutritional deficiency worldwide (both in children and adults), providing in-office testing to diagnose or monitor vitamin D deficiencies allows the physician office lab to deliver more personalized, patient-centric care. Sekisui Diagnostics