Chromogranin A New Gen ELISA
- Regulatory Status
- EU: CE
- Kit size
- 12 x 8
- Method
- ELISA
- Incubation time
- 1x 1 h; 1x 2 h; 1x 10 min
- Standard range
- 60 - 1,000 ng/mL
- Specimen / Volumes
- 20 µL Serum, Plasma
- Substrate / isotope
- TMB 450 nm
Chromogranin A
is the most important general marker for the diagnosis and clinical follow-up of neuroendocrine tumors. This marker is often elevated in patients with functionally active as well as inactive tumors. Unlike other biological markers, chromogranin A is relatively stable and largely correlates with the tumor mass. Tecan has been offering a Chromogranin A ELISA (CgA-ELISA, cat # 30126469) kit for many years.
In 2022, a new version of this kit (Chromogranin A New Gen. ELISA) is available and further improves the quality of the assays for this tumor marker.
All other parameters have been optimized to best meet the requirements. Incubation times have been reduced, dilution and recovery tests have been improved, the robustness of the kit has been optimized.
The new kit uses the same antibodies as the previous ones to maintain the same specificity. The antibodies are now produced in cell culture, thus reducing the use of animals.
Excellent correlation between Chromogranin A New Gen. ELISA and the Chromogranin A RIA-CT from CisBio
The experiment was performed on two batches of Chromogranin A New Gen. ELISA and 2 batches of Chromogranin A RIA-CT on 109 serum samples covering the whole calibration range.
The results below show a good correlation between the kits with a slope close to 1.0 which will facilitate the switch from radioimmunoassay to ELISA.
Excellent correlation between Chromogranin A New Gen. ELISA and the Chromogranin A ELISA
Similar correlation was performed using 53 samples covering the whole range of concentrations. The little gap on the slope is linked to the adjustment of the new kit to obtain optimal dilution performances along the calibration curve. Nevertheless, the correlation is good.
Essential analytical characteristics of the Chromogranin A New Gen. ELISA kit
Hook effect: No hook effect observed up to 2 million ng/mL.
Recovery and Dilution: To control the similarity of the assay response between exogenous CGA and serum CGA, recovery tests were performed. The results show a perfect similarity of the assays whatever the origin of the antigen hence meeting Cisbio internal standards in force (90%-110%).
As NETs can be associated with very high concentrations of CGA, out-of-range samples must be diluted. To ensure that dilutions do not compromise the accuracy of the results provided, cascade dilution tests were performed (1/2; 1/4, 1/8, 1/16). The results show very good dilution performances with a recovery close to 1.0, a slope interpolation close to 1.0 and a correlation coefficient also close to 1.0.
Biotin interferences: No significant interference up to biotin concentrations of 600 ng/mL.
Normal Values: Based on a serum library of 101 healthy samples, the distribution of normal values is shown below. The 95th percentile value that can be considered as a cut-off value is estimated at 101 ng/mL. However, It is recommended that each laboratory establishes its own range of reference intervals.
The assay procedures has also been simplified and a short scheme is provided below. Please refer to the instructions for use for details.
Product manufactured by CisBio, and distributed by Tecan, IBL International GmbH.
For concrete data please consult the Instruction for Use in the download box on the top right side.
Tsai et al, The prognostic and predictive role of CGA in gastroenteropancreatic neuroendocrine tumors- A single center experience. Forntiers in oncology, 11:article 741096, 2021
Dam et al, Prospective study of CGA as a predictor of progression in patients with pancreatic, small intestine and unknown primary neuroendocrine tumors. Neuroendocrinology 110: 217-224, 2020
Zhang C. et al, Serum chromogranin A for the diagnosis of gastroenteropancreatic neuroendocrine neoplasms and its association with tumour expression. Oncology Letters 17: 1497-1504, 2019
Jun E et al. Diagnostic value of chromogranin A in pancreatic neuroendocrine tumors depends on tumor size: A prospective observational study from a single institute. Surgery. 2017 Jul;162(1):120-30
Rogowski W et al. Baseline chromogranin A and its dynamics are prognostic markers in gastroenteropancreatic neuroendocrine tumors. Future Oncol. 2017;13(12):1069-79
Cheng Y et al. Serum chromogranin A levels for the diagnosis and follow-up of well-differentiated non-functioning neuroendocrine tumors. Tumour biology. 2016; 37(3):2863-9
d'Herbomez M et al. Biomarkers of neuroendocrine tumors. Ann Biol Clin. 2016; 74(6):669-79.
Erickson JA et al. A chromogranin A ELISA absent of an apparent high-dose hook effect observed in other chromogranin A ELISAs. Clin Chim Acta. 2016; 452:120-3
Gut P et al. Chromogranin A - unspecific neuroendocrine marker. Clinical utility and potential diagnostic pitfalls. Arch Medical Sci: AMS. 2016; 12(1):1-9
Kim M et al. The Role of Plasma Chromogranin A as Assessment of Treatment Response in Non-functioning Gastroenteropancreatic Neuroendocrine Tumors. Cancer Res treat. 2016; 48(1):153-61
Lyubimova NV et al. Chromogranin As a Biochemical Marker of Neuroendocrine Tumors. Bull Exp Biol Med. 2016; 160(5):702-4
Shanahan MA et al. Chromogranin A predicts survival for resected pancreatic neuroendocrine tumors. J Surg Res. 2016; 201(1):38-43
Glinicki P et al. Comparison of chromogranin A (CgA) levels in serum and plasma (EDTA2K) and the respective reference ranges in healthy males. Endokrynol Pol. 2015; 66(1):53-6.
Our Product Families
Our comprehensive immunoassay portfolio includes a number of specialty diagnostic immunoassays for endocrinology, immunology and autoimmunity, as well as for diagnosis of multiple infectious diseases. We are pioneers and market leaders in saliva diagnostics, with over 40 years of experience supplying a broad portfolio of luminescence- and ELISA-based tests, including our highly acclaimed HMGB1 and MuSK-Ab ELISAs.
And as experts in laboratory automation, we can support our customers with the protocols for open ELISA platforms, such as the Freedom EVOlyzer or Thunderbolt®.
All products are only available for sale to laboratory professionals and may not be available in all countries. Availability and regulatory status may vary across regions depending on local country-specific registration. Please always read and follow the instructions for use.
All of our assays have been designed and manufactured to meet the highest global regulatory requirements and quality standards. Tecan is certified under ISO 9001:2015, ISO 13485:2016 and is audited by a notified body according to Medical Device Single Audit Program (MDSAP).
This is who we are.
As part of the Tecan Group, we have a leading market position in diagnostics and research, with over 40 years of experience in the development, manufacture and supply of enzyme-, radiolabel- and luminescence-based immunoassays.
Our range of high-quality immunoassays is supported by a diverse portfolio of automated solutions, making us the perfect partner for you and your customers.
Happy to help.
At Tecan, we are driven to improve people’s lives and health.