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Neonatal Screening LC-MS/MS Analysis Kit

Neonatal Screening LC-MS/MS Analysis Kit
CE-IVD certified and suitable for any kind of LC-MS/MS instrument

 

The Zivak Neonatal LC-MS/MS analysis kit is manually available and not with the Zivak-Multitasker. Additionally, high accuracy is being rectified through external quality tests.

 

Neonatal screening for dried blood spot LC-MS/MS analysis kit.

Neonatal screening is the most important part of the clinical diagnosis of newborns with inborn errors of amino acid, fatty acid or organic acid metabolism. Expanded newborn screening allows to the diagnosis of over 30 metabolic diseases from a drop of blood samples taken from newborn’s heel with a screening card. This screening test occurred by measurement of some amino acids, free carnitine and acylcarnitines with isotope dilution tandem mass spectrometry. LC-MS/MS is a powerful tool for newborn screening gives results amino acids and acylcarnitines in 1.5 minutes.

Screening of following analytes can be performed with performed by Zivak Neonatal Screening LC-MS/MS Analysis Kit and Zivak NeoZin Newborn Screening software.

By the quantitative analysis of amino acids including alanine, glycine, valine, leucine, ornithine, methionine, phenylalanine, tyrosine, arginine, citrulline, aspartic acid, glutamic acid and argininosuccinic acid, disorders which are related with amino acid metabolism and urea cycle.

By the quantitative analysis of carnitine esters including free carnitine, C2, C4, C6, C8, C10, C12, C14, C16, C18 and C18:1 carnitine, disorders which are related with fatty acid oxidation.

By the quantitative analysis of carnitine esters including C3, C3DC, C4OH, C5, C5OH, C5DC carnitine, disorders which are related with organic acid metabolism.

 

Neonatal Screening LC-MS/MS Analysis Kit 0
LC-MS/MS Parameters

Device

Zivak Tandem Gold LC-MS/MS System

Column

Zivak Neonatal Screening Dried Blood Spots LC-MS/MS Trap Column Housing - Cartridge

Injection Volume

20 µL

Pump Program

00:00  min                   100% B

01:30  min                   100% B

Flow

0.30 mL/min

Ionization Mode:

ESI positive

CID Gas

2.0 mTorr

API Nebulizing Gas

55 psi

Scan Time

1.519 sec

SIM Width

1.5 amu

Drying Gas

30 psi

Drying Gas Temp.

350 °C

Needle

5000V

Shield

600V

Capillary

30V

Detector

1500 V

Analytical Performance

No

Analyte

LOD (µmol/L)

LOQ (µmol/L)

Accuracy

(%)

Intra-Assay

Precision  (%CV)

Inter-Assay

Precision

(%CV)

Linearity

(R2)

1

Alanine

0.40

1.2

95.1

2.21

3.3

0.994

2

Valine

0.25

0.75

97.4

2.73

3.5

0.985

3

Leucine

0.65

1.95

94.7

3.15

4.1

0.984

4

Methionine

0.53

1.59

96.2

2.18

3.3

0.985

5

Phenylalanine

0.77

2.31

95.3

3.64

 4.2

0.984

6

Arginine

0.53

1.59

94.2

2.52

3.1

0.993

7

Citrulline

0.25

0.75

97.5

3.43

4.5

0.997

8

Tyrosine

0.45

1.35

95.6

2.23

3.1

0.998

9

C0 Carnitine

0.02

0.07

96.7

4.02

5.2

0.985

10

C2 Carnitine

0.04

0.13

93.3

3.21

4.1

0.996

11

C3 Carnitine

0.02

0.07

98.3

2.32

3.3

0.994

12

C4 Carnitine

0.05

0.16

98.6

4.46

5.1

0.993

13

C5 Carnitine

0.02

0.07

97.6

3.36

4.3

0.994

14

C4OH Carnitine

0.05

0.14

95.6

3.22

4.1

0.996

15

C6 Carnitine

0.04

0.12

95.5

2.46

3.2

0.994

16

C5OH Carnitine

0.02

0.07

97.2

3.52

4.2

0.991

17

C8 Carnitine

0.09

0.26

96.9

2.46

3.5

0.992

18

C3DC Carnitine

0.07

0.20

92.7

1.27

2.5

0.996

19

C10 Carnitine

0.09

0.26

92.7

1.39

2.7

0.993

20

C5DC Carnitine

0.08

0.23

96.8

1.54

2.6

0.997

21

C12 Carnitine

0.07

0.20

93.5

2.26

3.5

0.996

22

C16OH Carnitine

0.09

0.13

95.7

3.42

4.5

0.996

23

C14 Carnitine

0.07

0.20

95.4

2.14

3.7

0.994

24

C16 Carnitine

0.08

0.23

94.5

3.57

4.6

0.993

25

C18OH Carnitine

0.09

0.08

93.1

3.27

3.9

0.993

26

C18 Carnitine

0.04

0.13

96.4

3.45

4.2

0.993

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Storage & Stability:

- This analysis kit can be shipped at room temperature.

- Controls, Reagent 1, 2, 3 should be stored at 2-8 °C.

- All other components of the kit can be stored at room temperature.

- All components are guaranteed until expiry date when stored at recommended temperatures and used as described in these instructions.

Sample Pretreatment (Manual):

Take dried blood spot sample in 3.5 mm diameter by a puncher on a 96-well microplate.

Add 200 mL of R1 to each well. Incubate for 30 minutes at room temperature.

After incubation, take the liquid phase on another well. Then dry with warm air flow.

Add 60 mL of R2 on dried samples.

Cover microplate properly with alumina foil or appropriate seal And incubate for 20 minutes at 65 °C.

Remove alumina foil and dry the liquid phase completely with warm air flow.

Add 200 µl of R3 to dissolve the dried wells.

Take the liquid into a vial or directly inject 20 µl from 96 well plate to LC-MS/MS system.

 

Note: The prepared sample is stable at 2-8°C for 24 hours.

 
Materials Supplied

Order No.

Volume

Component

ZV-3017-05R1-15

1 x 40 ml

Reagent 1, Contains deuterated internal standards

ZV-3017-05R2-15

1 x 12 ml

Reagent 2, Contains derivatization reagent

ZV-3017-05R3-15

1 x 40 ml

Reagent 3, Contains acid

  ZV-3017-05WB-15

 1 x 0,5 L

Washing solution, Contains organic solvent

ZV-3017-05MP-15

1 x  0,6 L

Mobile Phase, Contains organic solvent

ZV-3002-KK-15

1 x 1 pcs

User Manual

 

Materials Required But Not Supplied

Order No.

Volume

Component

ZV-3017-02S1-15

1 x 1 Spot

Dried Blood Spot Calibrator Level 1

ZV-3017-02S2-15

1 x 1 Spot

Dried Blood Spot Calibrator Level 2

ZV-3017-02S3-15

1 x 1 Spot

Dried Blood Spot Calibrator Level 3

ZV-3017-02K1-15

1 x 1 Spot

Dried Blood Spot Control Level 1

ZV-3017-02K2-15

1 x 1 Spot

Dried Blood Spot Control Level 2

ZV-3017-02C1-15

1 x 1 pcs

Zivak Neonatal Screening Dried Blood Spots LC-MS/MS Trap Column Housing

ZV-3017-CSPE-15

1 x 1 pcs

Neonatal Screening Dried Blood Spots LC-MS/MS Trap Column Cartridge

File Name Type Size Download
User Manual 1020.36 KB

Zivak General Catalog

Download Zivak General Catalog PDF