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Immunosuppressants LC-MS/MS analysis kit

Immunosuppressants LC-MS/MS analysis kit
CE-IVD certified and suitable for any kind of LC-MS/MS instrument
 

The Zivak Immunosuppressants (cyclosporine, everolimus, sirolimus and tacrolimus) LC-MS/MS  analysis kit can be used in combination with the Zivak-Multitasker as well as manually. Analysis run time for the manual version is 2 minutes. Due to the efficient and quite smart procedure of the Zivak-Multitasker, the automated version guarantees to receive results in just 2 minutes per test, including sample preparation-, sample injection- and analysis run time. Additionally, high accuracy is being rectified through external quality tests.

 
 

Quantitative LC-MS/MS analysis kit for Immunosuppressants including Sirolimus, Tacrolimus, Everolimus, Cyclosporin A in human whole blood samples.

Immunosuppressants are drugs that inhibit or prevent activity of the immune system. They are used in immunosuppressive therapy to prevent the rejection of transplanted organs and tissues (e.g., bone marrow, heart, kidney, liver) and treat autoimmune diseases or diseases that are most likely of autoimmune origin (e.g., rheumatoid arthritis, multiple sclerosis, myasthenia gravis, systemic lupus erythematosus, sarcoidosis, focal segmental glomerulosclerosis, Crohn's disease, Behcet's Disease, pemphigus, and ulcerative colitis). Immunosuppressants also can be used to treat some other non-autoimmune inflammatory diseases (e.g., long term allergic asthma control).

Most of the Immunosuppressants require monitoring blood concentrations, is called as therapeutic drug monitoring (TDM), for dosage adjustment. The measurement of low drug concentrations seen in biological fluids during drug treatment became possible by adopting new analytical technology. LC-MS/MS is a powerful tool for the measurement of the blood concentrations of the immunosupressants.

Zivak Immunosuppressants LC-MS/MS Analysis Kit was developed for quantitative monitoring of four immunosuppressants including Sirolimus, Tacrolimus, Everolimus and Cyclosporine in human whole blood samples and gives results in 2 minutes with minimal sample preparation. Main methods and procedures that have been selected are based on on EN ISO 13485 and 98/79/EC.

Immunosuppressants LC-MS/MS analysis kit 0
LC-MS/MS Parameters

Device

LC-MS/MS System with Zivak MULTITASKER

Column

Zivak Immunosuppressant Whole Blood LC-MS/MS Analytical Column

Injection Volume

20 µl

Pump Program

00:00 min                         33% B                         1.5 ml/min

00:24 min                         33% B                         1.5 ml/min

00:25 min                       100% B                         0.5 ml/min

00:54 min                       100% B                         0.5 ml/min

00:55 min                         33% B                         1.5 ml/min

02:00 min                         33% B                         1.5 ml/min

Ionization Mode

ESI Positive

CID Gas

2.00 mTorr

API Nabulizing Gas

55 psi

Vortex Gas

15 psi

Vortex Gas Temp.

150 °C

Drying Gas

20 psi

Drying Gas Temp.

200 °C

Spray Chamber Temp.

55 °C

SIM Width

Q1: 1.5 amu. Q3: 2.5 amu

Scan Time

0.8 sec

Needle Voltage

5000 V

Shield

600 V

Detector

1700 V

Column Oven

50 °C

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Analytical Performance

No

Analyte

LOD

(µg/L)

LOQ

(µg/L)

Accuracy

(%)

Intra-Assay

Precision

(%CV)

Inter-Assay

Precision

(%CV)

Linearity

(R2)

1

Tacrolimus

0.11

0.34

96.5

4.7

5.4

0.998

2

Sirolimus

0.19

0.65

98.4

3.2

3.8

0.999

3

Everolimus

0.16

0.50

95.7

3.7

4.3

0.997

4

Cyclosporine A

0.56

1.85

96.5

4.6

5.1

0.997

 

 

 

 

 

 

 

 

 

 

 

Storage & Stability:

  • This analysis kit can be shipped at room temperature.
  • After arrival, please make sure that you keep reagent P at room temperature otherwise it will become unusable. 
  • Standards and controls, Reagent 1 should be stored at 2-8 °C.
  • Standards and controls (after reconstitution) should be stored at - 20 °C. 
  • All other components of the kit should be stored at between room temperature. 
  • All components are guaranteed until expiry date when stored at recommended temperatures and used as described in these instructions.  

Preparation of Calibrators & Controls

Add 2 ml deionised water to whole blood calibrators/controls and dissolve. After preparation, calibrators and controls must be aliquoted into 175 µl volumes and stored at -20 °C.

 

Sample Pre-treatment (Automated)

1. Place blood collection tubes which contain whole blood samples directly into the vacutube tray.

2. Place empty Zivak Multitasker Samples preparation vials to the vial tray.

3. Place required volume of R1 and RP mixture to the reagent vial.

Note: The prepared sample is stable at 2-4°C for 24 hours.

 

Sample Pre-treatment (Manual)

1. Take 150 mL of patient sample (or calibrators and controls) into the sample preparation tube

2.  Add 300 mL (Reagent 1 and RP mix) and vortex for 30 seconds.

3. Centrifuge at 5000 x rpm for 5 minutes

4. Take the upper phase into the autosampler vial

5. Inject 20 mL to the LC-MS/MS system.

Note: The prepared sample is stable at 2-4°C for 24 hours.

Materials Supplied

Order No.

Volume

Component

ZV-3024-02R1-25

1 x 1,7 ml

Reagent 1, Contains lyophilized internal standards

ZV-3024-02RP-25

2 x 35 ml

Reagent P, Contains precipitation reagent

ZV-3024-02MT-25

1 x 1 L

SPE Buffer, Contains organic solvent

ZV-3024-02MP-25

1 x 0,5 L

Mobile Phase, Contains organic solvent

ZV-3024-02W1-25

1 x 1 L

Washing Solution 1, Contains organic solvent

ZV-3024-02R1-25

1 x 1 L

Washing Solution 2, Contains organic solvent

ZV-3024-02R1-25

1 x 1 pcs

User Manual

 
 
Materials Required But Not Supplied

Order No.

Volume

Component

ZV-3024-02S0-25

1 x 2 ml

Lyophilized Whole Blood Calibrator Level 0

ZV-3024-02S1-25

1 x 2 ml

Lyophilized Whole Blood Calibrator Level 1

ZV-3024-02S2-25

1 x 2 ml

Lyophilized Whole Blood Calibrator Level 2

ZV-3024-02S3-25

1 x 2 ml

Lyophilized Whole Blood Calibrator Level 3

ZV-3024-02S4-25

1 x 2 ml

Lyophilized Whole Blood Calibrator Level 4

ZV-3024-02S5-25

1 x 2 ml

Lyophilized Whole Blood Calibrator Level 5

ZV-3024-02S6-25

1 x 2 ml

Lyophilized Whole Blood Calibrator Level 6

ZV-3024-02K1-25

1 x 2 ml

Lyophilized Whole Blood Control Level 1

ZV-3024-02K2-25

1 x 2 ml

Lyophilized Whole Blood Control Level 2

ZV-3024-02K3-25

1 x 2 ml

Lyophilized Whole Blood Control Level 3

ZV-3024-02C1-25

1 x 1 pcs

Zivak Immunosuppressants Whole Blood LC-MS/MS Analytical Column

ZV-3024-02C2-25

1 x 1 pcs

Zivak Immunosuppressant Whole Blood LC-MS/MS Trap Column Housing

ZV-3024-CSPE-25

1 x 1 pcs

Zivak Immunosuppressant Whole Blood LC-MS/MS Trap Column Cartidge

ZS-2ML-8-1001

2 x 100 pcs

2 ml glass autosampler vial

ZS-9004-0100-00

2 x 100 pcs

2 ml glass autosampler vial caps pre-slit

 
 
 
 

Product Video

File Name Type Size Download
User Manual 1022.3 KB

Zivak General Catalog

Download Zivak General Catalog PDF