Product Overview
Thermo Scientific™ MAS™ T-Marker™ Controls are liquid, assayed, multi-analyte human-serum controls designed to monitor the performance of tumor-marker and related immunoassay test procedures on compatible automated analyzers. Three separately packaged levels allow laboratories to evaluate performance across clinically relevant portions of an assay range.
The controls are supplied ready to use without reconstitution and include assayed values for many major analyzer systems. Each level is packaged as six 3 mL vials, helping laboratories select the control levels appropriate for their quality-control program.
For in vitro diagnostic use. Instrument assignments, expected ranges, handling instructions and limitations are method-, lot- and platform-specific. Review the current package insert and lot-specific value sheet before use.
Three Control Levels
Levels 1, 2 and 3 are available separately for multi-level tumor-marker quality control.
Liquid, Ready to Use
No reconstitution is required; follow the package insert for thawing, mixing and handling.
Human-Serum Matrix
Multi-analyte control material designed for compatible automated immunoassay systems.
Designed for Routine Tumor-Marker Quality Control
Multi-Analyte Coverage
One control product covers a broad menu of tumor markers, hormones and related immunoassay analytes.
Independent Performance Monitoring
Supports laboratory evaluation of day-to-day assay performance using control material with platform-specific assigned values where available.
Extended Use After Opening
The current manufacturer listing states 30-day open-vial stability when stored at 2–8°C.
Analyte Coverage
The manufacturer lists the following analytes for MAS T-Marker Controls. Assigned values and expected ranges vary by control lot, method and analyzer platform.
- Adrenocorticotropic Hormone (ACTH)*
- Aldosterone
- Alpha-Fetoprotein (AFP)
- Beta Human Chorionic Gonadotropin (β-hCG)
- Beta-2-Microglobulin
- CA 125
- CA 15-3
- CA 19-9
- CA 27-29
- CA 72-4
- Calcitonin
- Carcinoembryonic Antigen (CEA)
- Cortisol
- CYFRA 21-1*
- Estradiol
- Ferritin
- Gastrin
- Human Chorionic Gonadotropin (hCG)
- Insulin
- Neuron-Specific Enolase (NSE)*
- Prolactin
- Prostate-Specific Antigen, Total (TPSA)
- Prostate-Specific Antigen, Free (FPSA)
- Prostatic Acid Phosphatase (PAP)
- Thyroglobulin
*Important: Thermo Fisher Scientific identifies ACTH, CYFRA 21-1 and NSE as constituents not cleared by the FDA. Their levels have not been adjusted and are present at levels found in the source material; no claim is made for expected values. Review current product labeling before use.
Available Levels and Pack Sizes
| Jant Catalog Number | Manufacturer Catalog Number | Control Level | Package |
|---|---|---|---|
| TFSTUM101 | TUM-101 | Level 1 | 6 × 3 mL |
| TFSTUM202 | TUM-202 | Level 2 | 6 × 3 mL |
| TFSTUM303 | TUM-303 | Level 3 | 6 × 3 mL |
Levels are supplied separately. Confirm the required level or combination of levels when requesting a quote.
Storage and Stability
Frozen Shelf Life
Current manufacturer information states up to 59 months at -25 to -15°C from the date of manufacture.
Unopened Refrigerated
Up to 90 days unopened at 2–8°C, according to the current manufacturer listing.
Open-Vial Stability
Up to 30 days after opening when stored at 2–8°C, according to the current manufacturer listing.
Always follow the expiration date, storage conditions and stability claims printed on the supplied lot and in its current package insert. Lot-specific labeling supersedes general website information.
Product Specifications
| Product | Thermo Scientific MAS T-Marker Controls |
|---|---|
| Description | Liquid, assayed, multi-analyte tumor-marker control |
| Intended Use | Monitoring the performance of applicable tumor-marker and related immunoassay test procedures on compatible automated instruments |
| Matrix | Human serum |
| Format | Liquid, ready to use; no reconstitution required |
| Levels | Level 1, Level 2 and Level 3; ordered separately |
| Package Size | Six 3 mL vials per level |
| Assayed Values | Available for many major analyzer systems; use the current lot-specific value sheet for the exact platform and method |
| Frozen Storage | -25 to -15°C; current manufacturer listing states up to 59 months from manufacture |
| Unopened Refrigerated Stability | Up to 90 days at 2–8°C, according to the current manufacturer listing |
| Open-Vial Stability | Up to 30 days at 2–8°C, according to the current manufacturer listing |
| Regulatory Use | For in vitro diagnostic use; see the current labeling for analyte-specific limitations |
| Unit of Measurement | Package |
Instrument and Lot-Specific Values
The MAS catalog identifies value assignments for many major automated immunoassay platforms. Examples named in the manufacturer literature include Abbott ARCHITECT, Beckman Coulter Access/DxI, Ortho VITROS ECi, Roche Modular E/Elecsys, Siemens ADVIA Centaur and IMMULITE, and Tosoh AIA 600II systems.
Do not assume universal compatibility. Before ordering or placing a new lot into service, confirm that the current lot-specific value sheet includes your exact analyzer, reagent method and units. If a method-specific assignment is unavailable, follow your laboratory’s procedures and the product instructions for establishing an appropriate range.
Important Quality-Control Information
- MAS T-Marker is a quality-control material and is not intended for calibration or direct patient testing.
- Use the current package insert and lot-specific value sheet supplied for the control lot.
- Expected ranges can vary by analyzer, assay reagent, method, unit and control lot.
- Laboratories should establish or verify their own acceptable control ranges according to the product instructions, laboratory policy and applicable requirements.
- Control frequency, acceptance criteria, corrective action and documentation are determined by the laboratory’s quality plan and applicable regulations.
- Because the matrix is human serum, handle the material using appropriate precautions for potentially infectious materials.
- Follow the current labeling for thawing, mixing, storage, open-vial dating and disposal.
- ACTH, CYFRA 21-1 and NSE carry manufacturer-specific FDA limitation language; review the current package insert before including them in a quality-control plan.
Explore Additional MAS Quality Controls
Jant Pharmacal offers additional Thermo Scientific MAS quality-control products for chemistry, immunoassay, cardiac, toxicology, urinalysis and other laboratory applications.
View Thermo Scientific MAS Quality ControlsDocumentation and Resources
Review the MAS quality-control literature and request the current product insert and lot-specific value sheet before implementation.
MAS Quality Controls Brochure MAS Quality Controls Catalog Request Current Lot DocumentationFrequently Asked Questions
MAS T-Marker Controls are multi-analyte human-serum controls used to monitor the performance of compatible tumor-marker and related immunoassay test procedures on automated laboratory analyzers.
No. They are quality-control materials. They are not intended for direct patient testing and should not be used as assay calibrators unless the applicable manufacturer labeling specifically provides otherwise.
Levels 1, 2 and 3 are available as separate products. Each level contains six 3 mL vials.
No reconstitution is required. The controls are supplied as a liquid, ready-to-use product. Follow the current package insert for thawing, mixing and handling instructions before analysis.
The manufacturer lists a broad panel that includes AFP, beta-2-microglobulin, CA 125, CA 15-3, CA 19-9, CA 27-29, CA 72-4, calcitonin, CEA, cortisol, estradiol, ferritin, gastrin, hCG, beta-hCG, insulin, prolactin, total and free PSA, PAP, thyroglobulin and additional constituents shown in the analyte section above.
The manufacturer provides assayed values for many major analyzer systems. Availability is lot-, instrument- and method-specific. Check the current lot-specific value sheet for your exact analyzer, reagent method and reporting units before use.
Current manufacturer information states storage at -25 to -15°C for long-term frozen shelf life. It also lists up to 90 days unopened and 30 days after opening at 2–8°C. Always use the expiration date and storage instructions supplied with the specific lot.
Thermo Fisher Scientific identifies these constituents as not cleared by the FDA and states that their levels have not been adjusted from the source material; no claim is made for expected values. Review the current package insert for the complete limitation language.
Review the current package insert, lot-specific value sheet or assay sheet, safety data sheet and your laboratory’s quality-control procedures. Confirm the analyzer, assay method, units, target mean and acceptable range before placing the lot into routine use.
Ordering Information
To confirm availability, current lot documentation or pricing, call Jant Pharmacal at 800.676.5565
| Catalog Number | Description | Unit of Measurement |
|---|---|---|
| TFSTUM101 | Thermo Scientific MAS T-Marker Controls, Level 1 | 6 × 3 mL |
| TFSTUM202 | Thermo Scientific MAS T-Marker Controls, Level 2 | 6 × 3 mL |
| TFSTUM303 | Thermo Scientific MAS T-Marker Controls, Level 3 | 6 × 3 mL |
Include the required control level, analyzer model and assay method with your inquiry. Request the current package insert and lot-specific value sheet before use.