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The IDS Cortisol assay is an in vitro diagnostic device intended for the quantitative determination of cortisol in human serum and plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to assist clinicians in the diagnosis and treatment of disorders of the adrenal gland.

The IDS Cortisol assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents: - MPE1:Magnetic particles coated rat anti-mouse monoclonal antibody in a phosphate buffer with Proclin as preservative. - CONJ: Cortisol coupled with an acridinium ester derivative in = phosphate buffer with Proclin as a preservative. - mAb: Mouse anti-cortisol monoclonal antibody in phosphate buffer with Proclin as a preservative .; - BUF: HEPES buffer containing Proclin as preservative .

The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget's disease.

The IDS-iSYS Ostase® BAP assay consists of one reagent cartridge and one set of calibrators (CAL A & CAL B). The reagent cartridge contains multiple reagents: - MPM1 (Magnetic particles coated with streptavidin in a phosphate buffer with sodium azide as preservative); - Ab-BIOT Monoclonal anti-BAP labelled with biotin, in buffer containing horse serum with bovine and mouse proteins and sodium azide as a preservative (<0.1 %) - -SUBS (p-nitrophenyl phosphate in a stabilising buffer containing preservatives). Calibrators A and B are buffered bovine protein matrix containing human BAP with sodium azide as preservative (<0.1 %).

The IDS SHBG assay is an in vitro diagnostic device intended for the quantitative determination of SHBG in human serum or plasma on the IDS System. Results are to be used as an aid in the diagnosis of androgen disorders

The IDS SHBG assay is an in vitro diagnostic device intended for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the diagnosis of androgen disorders. The assay is based on chemiluminescence technology. 5 uL of patient sample or calibrators are incubated with biotinylated monoclonal anti-SHBG antibody, an acridinium labelled monoclonal anti-SHBG conjugate and streptavidin labelled magnetic particles. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of analyte in the original sample. The IDS SHBG assay is an in vitro diagnostic device consisting of ready to use reagents provided in individual compartments within the reagent cartridge. The reagent cartridge contains: - Magnetic particles magnetic particles coated with streptavidin in a phosphate buffer containing preservatives - -Biotin antibody - monoclonal anti-SHBG labelled with biotin in a buffer containing proteins and preservatives - Conjugate monoclonal anti-SHBG labelled with an acridinium ester derivative in a buffer containing proteins and preservatives The calibrators consist of: - Calibrators A and B are included in the assay kit. The calibrators consist of a human serum matrix with defined concentrations of SHBG and preservatives. Together with a lot specific master calibration curve, the calibrators will be used to perform adjustment of the master calibration curve.

IDS-iSYS 17-OH Progesterone Control Set The IDS-iSYS 17-OH Progesterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS 17-OH Progesterone on the IDS-iSYS Multi-Discipline Automated System. Rx Only. IDS-iSYS 17-OH Progesterone Calibration Verifiers The IDS-iSYS 17-OH Progesterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS 17-OH Progesterone assay, when performed on the IDS-iSYS Multi Discipline Automated System. Rx Only.

The IDS-iSYS 17-OH Progesterone Control Set consists of Two sets of three vials, 1.0 mL each in liquid form. Human serum containing 17-OH Progesterone and sodium azide as a preservative (<0.1%), with three concentration levels. The IDS-iSYS 17-OH Progesterone Calibration Verifiers consists of Four calibration verifier levels in liquid form (two 1.0mL vials for level 0 and one 1.0mL vial for levels 1, 2 & 3). Human serum containing 17-OH Progesterone and sodium azide as a preservative (<0.1%), with three concentration levels.

The 25-Hydroxy Vitamin DS EIA assay is intended for the quantitative determination of 25-hydroxyvitamin D [25(OH)D] and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

The 25-Hydroxy Vitamin De EIA is a manual assay test and does not require the use of an automated system. The whole assay is performed in a microtitre plate and requires a user to perform each step. The 25-Hydroxy Vitamin De assay is an enzymeimmunoassay for the quantitation of 25(OH)D and other hydroxylated metabolites in serum or plasma. 25uL of each calibrators, controls and samples are diluted with biotin labelled 25(OH)D. The diluted samples are incubated in microtitre wells which are coated with a highly specific sheep 25(OH)D at room temperature before aspiration and washing. Enzyme (horseradish peroxidase) labelled avidin, is added and binds selectively to complexed biotin and, following a further wash step, colour is developed using a chromogenic substrate (TMB). The absorbance of the stopped reaction mixtures are read in a microtitre plate reader, colour intensity developed being inversely proportional to the concentration of 25(OH)D.

The IDS-iSYS Aldosterone assay (IS-3300) is a device intended for use in clinical laboratories for the quantitative determination of Aldosterone in human EDTA plasma on the IDS-iSYS Multi-Discipline Automated System. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of Aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hyperaldosteronism, edematous states and other conditions of electrolyte balance. The IDS-iSYS Aldosterone Control Set (IS-3330) is intended for use as assaved quality control samples to monitor the accuracy of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System. The IDS-iSYS Aldosterone Calibration Verifiers (IS-3335) are intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS Aldosterone assay is based on chemiluminescence technology. A biotinylated monoclonal anti-Aldosterone antibody is incubated with the sample, after an incubation step an Aldosterone acridinium conjugate is added and after a further incubation step streptavidin coated magnetic particles are added. Following a third incubation step the particles are "captured" using a magnet. After a washing step and addition of trigger reagents, the light emitted by the acridinium label is inversely proportional to the concentration of Aldosterone in the original sample.

The IDS-iSYS CTX-1 (CrossLaps ®) Calibration Verifiers is a device intended for the verification of the IDS-iSYS CTX-I (CrossLaps ®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer

The IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers consists of one set of four vials, 2.5 mL each in liquid form, containing horse serum with <0.1% (w/w) sodium azide as a preservative, with four concentration levels of human CTX-I: Cal. Ver. 0: Undetectable Cal. Ver. 1: 0.12 - 0.16 ng/mL Cal. Ver. 2: 2.4 - 3.2 ng/mL Cal. Ver. 3: 5.6 - 6.6 ng/mL

The IDS iSYS 25-Hydroxy Vitamin DS Assay (IDS-iSYS 250HD*) is intended for the quantitative determination of 25-hydroxyvitamin D (25OHD) and other hydroxylated metabolites in human serum on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population. The IDS-iSYS 25-Hydroxy Vitamin DS (250HDS) Control Set is used for quality control of the IDSiSYS 25-Hydroxy Vitamin DS assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS 25-Hydroxy Vitamin DS assay consists of a reagent cartridge and one set of calibrators (Calibrators A & B or CAL A & CAL B). The reagent cartridge contains multiple reagents: MPV1 (Magnetic particles coated with 25-OH D in a phosphate buffer containing methanol with sodium azide as preservative), CONJ (Anti- 25-OH D sheep polyclonal antibody labelled with an acridinium ester derivative, in buffer containing bovine, sheep, rabbit and mouse proteins with sodium azide as preservative), NaOH (Sodium hydroxide solution <0.5 M), and BUF (Assay buffer containing proprietary displacing compounds, methanol, and sodium azide as preservative). Calibrators A and B contain horse serum in a buffer matrix with two defined concentrations of 25-OH D and sodium azide as a preservative. The IDS-iSYS 25-Hydroxy Vitamin DS Control Set contains horse serum in a buffer matrix with three defined concentrations of 25-OH D and sodium azide as a preservative.

The IDS-iSYS Direct Renin assay is intended for the quantitative determination of Direct Renin in human EDTA plasma on the IDS iSYS Multi-Discipline Automated System. Renin measurements may aid in the diagnosis and treatment of certain types of hypertension. The IDS-iSYS Direct Renin Control Set is used for quality control of the IDS-iSYS Direct Renin Assay on the IDS-iSYS Multi-Discipline Automated System. The IDS-iSYS Direct Renin Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Direct Renin Assay when performed on the IDSiSYS Multi-Discipline Automated System.

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The IDS-iSYS 1,25 Dihydroxy Vitamin D assay is intended for the determination of 1,25 dihydroxyvitamin D levels in serum and plasma on the IDS-iSYS Multi-Discipline Automated System. Results of the 1.25 Dihydroxy Vitamin D are used in the assessment of vitamin D sufficiency. The IDS-iSYS 1,25 Dihydroxy Vitamin D Control Set is used for quality control of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay on the IDS-iSYS Multi-Discipline Automated System The IDS-iSYS 1,25 Dihydroxy Vitamin D Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

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