Multi-Constituent Controls
From the company that brought you CA 125, CA 19-9, and CA 15-3, the "Gold Standard" IVD manufacturer for tumor marker reagents now brings you a multi-constituent Tumor Marker Control, exclusively including the novel biomarker HE4.
Laboratories can utilize the Fujirebio Diagnostics Tumor Marker Control as an independent internal quality control to monitor the performance of their tumor marker testing.
Tumor Marker Control:
- The only available multi-constituent control containing the novel biomarker HE4
- Contains clinically relevant proportions of FREE PSA and PSA-ACT
- Contains medically relevant levels for HE4, AFP, CA 125, CA 15-3, CA 19-9, CEA, Ferritin, PSA, and Free PSA
- Lyophilized, 100% human serum matrix
- Reconstituted stability up to 60 days at <-20°C
- Stable for up to 9 freeze/thaw cycles
- Assayed values available for manual and automated methodologies
- Reputation as a "high quality" IVD manufacturer, "gold standard" for tumor markers
Intended Use
For In Vitro Diagnostic Use Only
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, HE4, PSA and Free PSA.
Description
| Name | Catalog Number |
Matrix | Levels | Quantity |
|---|---|---|---|---|
| Tumor Marker Control1 |
108-20 | 100% Human Serum, Lyophilized |
2 | Level 1: 3 x 3 mL Level 2: 3 x 3 mL |
(1) in vitro Diagnostic Product
Packaging: 6 x 3 mL (3 vials of each of 2 levels – Lyophilized)
Typical Values
These values are provided solely for the convenience of the laboratory prior to the assessment of the control. Values were obtained from testing performed on the Abbott ARCHITECT and AxSYM Immunoassay systems except for HE4 (Fujirebio Diagnostics, Inc. EIA). Please refer to lab specific assigned value sheet. It is recommended that each laboratory establish its own means and acceptable ranges and use the printed ranges as guidance only.
| Analyte | Reference Ranges |
Typical Range Level 1 |
Typical Range Level 2 |
Assay Unit |
SI Unit |
|---|---|---|---|---|---|
| AFP | <10.01 | 15.4 – 28.6 | 193 – 344 | ng/mL | µg/L |
| CA 15-3 | <301 | 11.9 – 22.1 | 105 – 195 | U/mL | U/mL |
| CA 19-9 | <371 | 39.2 – 72.8 | 431 - 8003 | U/mL | U/mL |
| CA 125 | <351 | 17.5 – 32.5 | 280 – 520 | U/mL | U/mL |
| CEA | Non-Smokers <3.01 & Smokers <5.01 |
3.5 – 6.5 | 42.0 – 78.0 | ng/mL | µg/L |
| HE4 | ≤1502 | 50.0 – 100.0 | 450 - 850 | pM | pM |
| FERRITIN | Male 20-2501 Female 10-1201 |
31.5 – 75.0 | 280 – 520 | ng/mL | µg/L |
| FREE PSA | ≤25% of total PSA1 | > 1.0 | 7.0 – 19.0 | ng/mL | µg/L |
| PSA | <4.01 | 2.3 – 4.2 | 21.0 - 39.0 | ng/mL | µg/L |
1Wu, Alan. Tietz Clinical Guide To Laboratory Tests. St. Louis: W. B. Saunders Company, 2006. Print.
2Fujirebio Diagnostics AB Gothenburg, Sweden. HE4 EIA Assay Insert, 404-10US, 2008-06, F5908, r1.
3Higher values as seen with Abbott ARCHITECT assay.
For more information about a local distributor please contact us at +46 31 85 70 30.
Architect and AxSYM are registered trademarks of Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA