MassTrak Steroid Serum IVD Sets
Ensure accurate steroid measurements for your clinical tests
Quantification of steroids is more beneficial using LC-MS/MS, as opposed to traditional ligand binding techniques such as immunoassay, as it enables simultaneous quantification of multiple analytes, while providing higher analytical sensitivity and selectivity over an extended measuring range to support samples from various patient cohorts.
The MassTrak Steroid Serum Sets comprise of metrologically traceable IVD* steroid calibrators and controls, as well internal standards and optimization mix in an easy-to-use format to save your laboratory time and resources spent on preparing these in house.
*The MassTrak Steroid Serum Cal Set 1, 2, and 3, MassTrak Steroid Serum QC Set 1, 2, and 3, MassTrak Steroid Internal Standard Mix, MassTrak Steroid Optimization Mix are IVDR (EU) compliant.
Additionally, the MassTrak Steroid Serum IVD Calibrator, Internal Standard Set, and Optimization Mix are listed with the FDA as Class 2 Devices. The MassTrak Steroid Serum IVD QC set is listed with the FDA as a Class 1 Device.
MassTrak Steroid Serum IVD Sets
用於體外診斷用途。並非在所有國家/地區均可使用。
Specifications
Overview
- MassTrak Steroid Serum Sets contain a comprehensive list of IVD standards needed for LDT development – calibrators, quality controls, internal standards, and optimization mix, saving up to three months of resource time to complete the full production process of similar standards in house
- NIST CRM and reference measurement (Ghent/Rfb) traceable calibrators and quality controls, each sourced from different CRM*, help in your laboratory’s compliance to ISO 15189 and CLSI C62-A
- 3 separate analyte panels (containing 12, 4, and 5 steroid hormones respectively) are available so your laboratory can analyze only analytes that are requested and meet turnaround time expectations
- Broad calibrator concentration ranges, wider than known reference ranges**
- High lot-to-lot manufacturing and value assignment consistency enables excellent LCMS method performance in peer lab comparison (<10% bias from EQA ALTM achieved during in-house testing)
- 3x longer in-use stability at 2–8 °C for calibrators and controls, compared to similar products by known competitors, enables consumption of this product over an extended period of time
**Source for reference range: Tietz Textbook of Clinical Chemistry & Molecular Diagnostics
Recommended Use: For quantitative determination of steroids in human serum.
MassTrak Steroid Serum IVD Sets
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IVD Cal Set containing 12 lyophilized steroid analytes -
Format: 7 x 2 mL (Reconstitution volume)
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Shelf life: 3 years at ≤ -10 °C
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In-use stability: 3 months at ≤ -10 °C ; 1 month at 2-8 °C
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IVD QC Set containing 12 lyophilized steroid analytes
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Format: 3 x 2 mL (Reconstitution volume)
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Shelf life: 3 years at ≤ -10 °C
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In-use stability: 3 months at ≤ -10 °C ; 1 month at 2-8 °C
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IVD Cal Set containing 4 lyophilized steroid analytes
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Format: 8 x 2 mL (Reconstitution volume)
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Shelf life: 3 years at ≤ -10 °C
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In-use stability: 3 months at ≤ -10 °C ; 1 month at 2-8 °C
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IVD QC Set containing 4 lyophilized steroid analytes
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Format: 4 x 2 mL (Reconstitution volume)
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Shelf life: 3 years at ≤ -10 °C
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In-use stability: 3 months at ≤ -10 °C ; 1 month at 2-8 °C
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IVD Cal Set containing 5 lyophilized steroid analytes
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Format: 8 x 2 mL (Reconstitution volume)
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Shelf life: 3 years at ≤ -10 °C
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In-use stability: 3 months at ≤ -10 °C ; 1 month at 2-8 °C
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IVD QC Set containing 5 lyophilized steroid analytes
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Format: 4 x 2 mL (Reconstitution volume)
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Shelf life: 3 years at ≤ -10 °C
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In-use stability: 3 months at ≤ -10 °C ; 1 month at 2-8 °C
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IVD Internal Standard Set containing 12 lyophilized steroid analytes
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Format: 1 x 25 mL (Reconstitution volume)
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Shelf life: 1.5 years at ≤ -10 °C
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In-use stability: 3 months at ≤ -10 °C
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IVD Optimization Mix containing 12 lyophilized steroid analytes
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Format: 1 x 2 mL (Reconstitution volume)
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Shelf life: 1.5 years at ≤ -10 °C
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In-use stability: 3 months at ≤ -10 °C
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IVD Cal 0 containing serum matrix
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Format: 1 x 2 mL (Reconstitution volume)
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Shelf life: 3 years at ≤ -10 °C
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In-use stability: 3 months at ≤ -10 °C; 1 month at 2-8 °C
Ensure accurate steroid results with serum calibrator sets
Our IVD serum calibrator sets, MassTrak Steroid Serum Cal Set 1, MassTrak Steroid Serum Cal Set 2, and MassTrak Steroid Serum Cal Set 3 are ideal for quantifying steroids in human serum. These are traceable to NIST CRM and reference measurement procedures such as RfB (Germany) and University of Ghent for select analytes with customer-guided wide concentration ranges for all analytes.
Typical concentration values are shown in the table images. Please refer to your lot-specific certificate of analysis (COA) for exact concentrations. The COA can be found in the box or on Waters.com.
Ensure consistency with the high lot-to-lot manufacturing of QC sets
Our IVD serum QC sets, MassTrak Steroid Serum QC Set 1, MassTrak Steroid Serum QC Set 2, and MassTrak Steroid Serum QC Set 3 are also traceable to NIST CRM and reference measurement procedures such as RfB (Germany) and University of Ghent for select analytes. The concentration values for the controls are based on customer feedback, Endocrine Society guidelines and CDC NSQAP.
Typical concentration values are shown in the table images. Please refer to your lot-specific certificate of analysis (COA) for exact concentrations. The COA can be found in the box or on Waters.com.
Internal Standard and Optimization Mix for steroid LC-MS methods
Our IVD MassTrak Internal Standard and Optimization Mix offer highly pure lyophilized labeled and non-labeled standards for use with calibrators and controls in steroid LC-MS methods.
MassTrak Steroid Serum Internal Standard Mix contain 12 lyophilized steroid analytes: 13C3-androstenedione, 2H4-corticosterone, 13C3-cortisol, 13C3-11-deoxycorticosterone, 13C3-11-deoxycortisol, 2H4-21-deoxycortisol, 13C3-DHEA, 2H6-DHEAS, 13C3-dihydrotestosterone, 13C3-17- hydroxyprogesterone, 13C3-progesterone, and 13C3-testosterone.
MassTrak Steroid Serum Optimization Mix contain 12 lyophilized steroid analytes: androstenedione, corticosterone, cortisol, 11-deoxycorticosterone, 11-deoxycortisol, 21-deoxycortisol, DHEA, DHEAS, dihydrotestosterone, 17- hydroxyprogesterone, and progesterone.
