Chromogranin A NEOLISA™

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This assay is a sandwich ELISA for measurement of Chromogranin A (CgA) in human serum or plasma. The assay is easy to use with short incubation time (105 min in total), no hook effect (tested up to 360 000 ng/mL) and excellent linearity.

The assay is CE marked and suitable for automation. It´s clinical performance has been compared with other kits on the market and a kit comparison study was presented during the UKI NETS meeting in London 2013 (link to Poster 32, UKI Nets, London Nov 2013).

CgA is generally considered the most useful serological marker for tumours of neuroendocrine origin and is routinely used in various phases of the management of patients suffering from NETs (Neuroendocrine tumours). In recent years several international guidelines, which highly recommend the use of CgA in the management of NET patients, have been published1-3.

  1. Ramage J K et al, Gut 2012;61:6-32
  2. Pape U-F et al, Neuroendocrinology 2012;95:135–156
  3. Vinik, A et al, Pancreas 2010; 39(6):713-734

Product code
CGA
Format
ELISA
Tests
96 wells
Calculation
Quantitative
Units
ng/mL or nmol/L or U/L
Calibrators
6
Range
0-1800 ng/mL (0-50 nmol/L)
Incubation time
60+30+15 min
Detection system
450 nm
Availability
CE marked. Available in US only for research use, not for IVD use

Intended use

The NEOLISA™ Chromogranin A test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and quantitation of chromogranin A in human plasma or serum. The results of the assay may be used as an aid in the diagnosis of chromogranin A secreting neuroendocrine tumours (NETs), such as phaeochromocytomas and carcinoids. The assay is intended for use in patients with signs and symptoms consistent for NETs. It is not intended for screening a healthy population. 

The analysis should be performed by trained laboratory professionals.

This product is also available as research use only. Product code: CGA RUO

For complete product description, claims and use, please refer to the Instructions For Use. Contact your local representative for availability in your country.

Background

In a separate dilution plate patient samples, calibrators and controls are diluted 5x in Diluent. The diluted material is transferred to the microtitre wells and incubated at room temperature for 60 minutes. During this first incubation a monoclonal antibody captures the chromogranin A to surface of the well. After washing to remove unbound material a second, horseradish peroxidase (HRP) labelled monoclonal antibody is added to detect the chromogranin A bound to the well. After incubation for 30 minutes the wells are washed again and a colour substrate is added and incubated. The colour development is stopped after 15 minutes and the colour measured in a spectrophotometer. The colour is directly proportional to the amount of chromogranin A bound to the well. The amount of chromogranin is determined by comparison with the colour development of the calibrator samples.

The calibrator in the kit is a synthetic peptide corresponding to chromogranin A. The peptide calibrator is set to give a response equal to a purified, native fragment of chromogranin A (Stridsberg, M et al. 1993, Stridsberg et al. 1995)

Kit components

One frame with 96 wells, sealed in a foil pack with a dry pack.

- Six vials with lyophilised calibrators containing human Chromogranin A in diluent. Cal 1 = 0 ng/mL (diluent), Cal 2 = 36 ng/mL, Cal 3 = 180 ng/mL, Cal 4 = 540 ng/mL, Cal 5 = 1080 ng/mL, Cal 6 = 1800 ng/mL.

- One vial with lyophilised Low control (L) .

- One vial with lyophilised High control (H).

- 30 mL Diluent (Dil), red colour. Ready to use.

- 150 µL conjugate containing HRP-labelled antibodies to Chromogranin A. 100x concentrated.

- 15 mL conjugate buffer (blue colour). Ready to use.

- 15 mL Substrate TMB. Ready to use.

- 15 mL Stop solution (0.5M H2SO4). Ready to use.

- 2x35 mL wash solution, 20x concentrated.