Currently available creatinine reagents with the information on assay traceability – unpublished data from Radišić Biljak V and Jones G.
| Company | Test Kit Name | Assay Type | Supplied Calibration Information | “IDMS traceable” |
|---|---|---|---|---|
| Abbott | - | Jaffe | Calibrator values traceable to SRM 967 using IDMS | Yes |
| Abbott | - | Enzymatic | Calibrator values traceable to SRM 967 using IDMS | Yes |
| Abbott | Creatinine | Jaffe | For information on calibrator standardization, refer to Multiconstituent Calibrator package insert. | Not declared |
| Abbott | Creatinine (Enzymatic) | Enzymatic | For information on calibrator standardization, refer to the MULTIGENT Clin Chem Cal package insert | Not declared |
| Abbott | i-STAT creatinine | Enzymatic (whole blood) | Creatinine values assigned to i-STAT controls and calibration verification materials are traceable to the US National Institute of Standards and Technology (NIST) standard reference material (SRM967). Further information available from Abbott. | Yes |
| Accurex | AutoZyme Creatinine | Jaffe | Not specified | Not specified |
| AMS Diagnostics | Creatinine Reagent | Jaffe | Use an aqueous creatinine standard or an appropriate serum calibrator | Not specified |
| Arkray | Spotchem creatinine | Reagent strip | Spot chem calibrator or calibration by reagent card | Not specified |
| Audit Diagnostics | Creatinine Jaffe | Jaffe | Standard (177 μmol/L) | Not specified |
| Beckman Coulter | CR-S | Jaffe | IDMS (in calibrator IFU, Aqua Cal) | Yes |
| Beckman Coulter | CR-E | Enzymatic | IDMS (in calibrator IFU, Aqua Cal) | Yes |
| Beckman Coulter (Olympus) | Creatinine | Jaffe | Cal values Traceable NIST or Thermo Fisher Scientific 2 / NERL or reference methods. | Yes |
| Beckman Coulter | Creatinine | Jaffe | Cal values traceable to NIST SRM 967 for method A. Cal values traceable to NIST SRM 909b for method B. |
Yes |
| Beckman Coulter | Creatinine (Enzymatic) | Enzymatic | Cal values traceable to NIST SRM 967 | Yes |
| BioMed Diagnostics | Creatinine | Jaffe, Colorimetric, endpoint | Creatinine standard supplied (2.0 mg/dL) | Not specified |
| BioMed Diagnostics | Creatinine | Jaffe, fixed rate | Creatinine standard supplied (2.0 mg/dL) | Not specified |
| Biotecnica | Creatinine | Jaffe | The concentration of the supplied standard was determined using the NIST 914a international standard. | Yes |
| BQ Kits | Creatinine Liquid Reagents Assay | Enzymatic | Calibrator included. Traceable to NIST SRM 914a. | Yes |
| Chemhouse | Creatinine (kinetic, Jaffes method) | Jaffe | Creatinine standard 2 mg/dL | Not specified |
| Diasys | Creatinine FS | Jaffe | Standard (2 mg/dL). Subtract 27 μmol/L for compensated method | Yes |
| Diasys | Creatinine PAP FS | Enzymatic | Standard (2 mg/dL). | Yes |
| Diazyme | Enzymatic creatinine | Enzymatic | calibrator provided is traceable to NIST’s SRM 967 (GC-IDMS and LC-IDMS) | Yes |
| Fortress diagnostics | Creatinine | Jaffe | For automated systems recommend a serum based calibrator to eliminate any matrix bias which may be observed with the aqueous standard. Fortress calibrator Cat BXCO321K/L/M | Not specified |
| Fortress diagnostics | Creatinine | Jaffe - deproteinised | Supplied standard 177 μmol/L. | Not specified |
| Fortress diagnostics | Creatinine | Jaffe - deproteinised | For automated use we recommend a serum based calibrator to eliminate any matrix bias which may be observed with the aqueous standard. Fortress Calibrator cat. No BXC0321K/L/M | Yes |
| Fujifilm | Dri-chem slide CRE-PIII | Enzymatic (for Fuji analyser) | Traceability of Calibrators: NIST (SRM 914) Note reference material is applied to the reference method of Fujifilm corporation and is not directly applicable to the Fuji dri-chem slide | Yes |
| Genzyme | Creatinine-S Assay | Jaffe | Calibration material not supplied | Not specified |
| I.S.E. S.r.l. | Creatinine | Jaffe | Multicalibrator I.S.E code R030000006 | Not specified |
| IBL America | Creatinine Liquid Reagents Assay | Enzymatic | Calibrator included. Traceable to NIST SRM 914a. | Yes |
| ID Labs | IDTox Creatinine Enzymatic | Jaffe, microplate | Standard “20 g/dL” | Not specified |
| Ortho Clinical Diagnostics | - | Enzymatic | Not specified | Yes |
| Nova Biomedical | Creatinine whole blood | - | Not specified | Adjustable |
| Piccolo | Kidney Check | Enzymatic | Not specified | Not specified |
| Pointe Scientific | Creatinine reagent set | Jaffe | Use an NIST traceable creatinine standard (2.5 mg/dL) or serum calibrator. | Not specified |
| Pointe Scientific | Creatinine reagent set | Enzymatic | Use an NIST traceable creatinine standard (2.5 mg/dL) or serum calibrator. | Not specified |
| Robonik | Prietest Creatinine | Jaffe | Standard provided (2 mg/dL) | Not specified |
| Roche | Creatinine Jaffe method | Jaffe | This method has been standardised against IDMS (Isotope Dilution Mass Spectrometry). For the USA the method has been standardised against a primary reference mterial (SRM 914). | Yes |
| Roche | Creatinine Jaffe Gen.2 | Jaffe | This method has been standardised against IDMS (Isotope Dilution Mass Spectrometry). For the USA the method has been standardised against a primary reference material (SRM 914 and SRM 967 (IDMS)). | Yes |
| Roche | Crea plus | Enzymatic | This method has been standardised against IDMS (Isotope Dilution Mass Spectrometry). | Yes |
| Roche | Crea plus ver.2 | Enzymatic | This method has been standardised against IDMS (Isotope Dilution Mass Spectrometry). | Yes |
| Sekisui | Enzymatic Creatinine 265 series | Enzymatic | Not specified | Yes |
| Sekisui | Enzymatic Creatinine 265 series | Jaffe | Not specified | Yes |
| Sentinel | Creatinine | Jaffe | IFU not seen | Not specified |
| Sentinel | Multigent Creatinine | Enzymatic | correlation with Roche enzymatic (on DXc) | Yes |
| Siemens -Advia | - | Jaffe | IFU not seen - Claim at NKDEP | Yes |
| Siemens - Advia | - | Enzymatic | IFU not seen - Claim at NKDEP | Yes |
| Siemens - Dimension | - | Jaffe | Not specified | No |
| Spectrum (Egyptian Company for Biotechnology) | Creatinine - Jaffe (single reagent) | Jaffe | Standard 2 mg/dL | Not specified |
| Spinreact | Creatinine | Jaffe | Calibration with aqueous calibrator may cause a systematic error in automated procedures. In these cases it is recommended to use a serum calibrator. | Not specified |
| Spinreact | Creatinine | Enzymatic | Calibration with aqueous calibrator may cause matrix related bias, it is recommended to use a serum based calibrator. | Not specified |
| Stanbio | Creatinine Liquicolor test (kinetic) | Jaffe | Standard included | Not specified |
| Thermo | Infinity Creatinine Liquid stable reagent | Jaffe | “Calibrator or suitable aqueous creatinine standard”. “An aqueous standard or serum based calibrator with and assigned value traceable to a primary standard (e.g. NIST or IRMM) is recommended” | Not specified |
| Thermo | Creatinine reagent - Enzymatic | Enzymatic | An aqueous standard or serum based calibrator with an assigned value traceable to a primary standard (e.g. NIST or IRMM) is recommended | Not specified |
| VITROSCIENT | Creatinine (fixed rate) | Jaffe | Standard not defined | Not specified |
| VITROSCIENT | Creatinine (fixed rate) | Jaffe, deproteinised | Standard not defined | Not specified |
| WAKO | Creatinine M L-type | Enzymatic | Wako system calibrator (available separately) | Not specified |
| Wiener | Creatinina directa | Jaffe | Standard 20 mg/L creatinine solution | Not specified |
| Wiener | Creatinina directa | Enzymatic | Wiener Lab Calibrator (3 values for creatinine depending on Wiener method) | Not specified |
| DiaSystem Scandinavia AB | Creatinine Jaffe | Jaffe | Calibrators traceable to NIST 9167, subtract 27 μmol/L | Yes |
| Medichem | Enzymatic | Not specified | Not specified | |
| Randox | Enzymatic | Not specified | Not specified | |
| Diachem | CREATININE ENZYMATIC | Enzymatic | Calibration: S2: Creatinine standard found in the kit or Roche C.F.A.S. (Calibrator for automated system) or Roche cfas or Randox cal Li or level II | Not specified |
| Pariksha Biotek | CREATININE - 2R KIT | Jaffe | Not specified | Not specified |
| Coral Clinical Systems | Creatinine Kit (Mod Jaffe’s kinetic method) | Jaffe | Supplied standard 177 μmol/L. “standard is traceable to standard reference material (SRM) 909b.” | Not specified |
| Ensure Biotech | Creatinine EPK | Jaffe | Supplied standard 177 μmol/L. | Not specified |
| Kamineni Life Sciences | Lifechem Creatinine-LR | Jaffe | Supplied standard 177 μmol/L. | Not specified |
| KEE GAD Biogen | Creatinine (Jaffe’s method) | Jaffe | Supplied standard 177 μmol/L. | Not specified |
| Recombigen | Creatinine (Alkaline Picrate method) | Jaffe with deproteinisation | Supplied standard 177 μmol/L. | Not specified |
| AGGAPE Diagnostics | Enzymatic Creatinine | Enzymatic | Supplied standard 177 μmol/L. | Not specified |
| Linear Chemicals SL | Cromatest Creatinine | Jaffe | Supplied standard 177 umol/L. “Organic matrix based primary standard. Concentration value is traceable to Standard Reference Material 914a.” | |
| Polymer Technology | PTS PANELS Creatinine Test Strips | Enzymatic test strips for use in CadioChek PA analyser | predicate device comparison: A = 0.93 x B +0.49 mg/dL | Not specified |
| bioMerieux SA | Créatinine cinétique (CREA) | Jaffe | - Use Calimat (Ref. 62 321): multiparametric calibrator linked with SRM 909 or - Use Reagent 1 (Ref. 61 162) linked with SRM 914 Titer of Reagent 1:132.6 μmol/L Aqueous solution prepared using 99% pure creatinine |
Not specified |
| Dijagnostika d.o.o. | Kreatinin kinetički | Jaffe | An aqueous standard or serum based calibrator with and assigned value traceable to a primary standard (eg NIST or IRMM) is recommended | Not specified |
| Dijagnostika d.o.o. | Kreatinin DST (liquid) |
Jaffe | An aqueous standard or serum based calibrator with and assigned value traceable to a primary standard (eg NIST or IRMM) is recommended | Not specified |
| Horiba ABX SAS | ABX Pentra Creatinine 120 CP | Jaffe | ABX Pentra Multical required | Not specified |
| Horiba ABX SAS | ABX Pentra Enzymatic Creatinine CP | Enzymatic | ABX Pentra Multical required | Not specified |
| Human | auto-CREATININE liquicolor | Jaffe | auto-CREATININE is calibrated with AUTOCAL, which is traceable to the reference material SRM 909b level 2. | Not specified |
| Human | CREATININE (ENZYM) liquicolor | Enzymatic | The method is traceable to the SRM 909c. | Not specified |
| Human | CREATININE liquicolor | Jaffe | The method is traceable to the SRM 909b | Not specified |