Tumour (monitoring) array iii

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INTENDED USE

The Evidence Investigator Tumour Array 3 (Monitoring) is to be used for the in vitro simultaneous quantitative detection of multiple related tumour immunoassays (in parallel) from a single patient sample.

Tumour Array 3 (Monitoring) is for research purposes only and should not be used for diagnostic procedures.

CLINICAL SIGNIFICANCE

The assaying of tumour markers has become one of the most rapidly growing areas in all laboratory medicine. With the identification of these markers we are getting closer to more efficient and accurate diagnosis and monitoring of different cancers to improve our success in the worldwide fight against cancer.

PRINCIPLE

Evidence Investigator Biochip Array Technology is used to perform simultaneous quantitative detection of multiple analytes from a single patient sample. The core technology is the Randox Biochip, a solid substrate containing an array of discrete test regions of immobilised antibodies specific to different Tumour Array 3 (Monitoring) markers. A sandwich chemiluminescent immunoassay is employed. Increased levels of Tumour Array 3 (Monitoring) markers in a sample will lead to increased binding of antibody labelled with horseradish peroxidase (HRP) and thus an increase in the chemiluminescence signal emitted. The light signal generated from each of the test regions on the biochip is detected using state-of-the-art digital imaging technology and compared to that from a stored calibration curve. The concentration of analyte present in the sample is then calculated from the calibration curve.

Several different immunoassay based multi-analyte panels have been developed for use on Evidence Investigator . The Tumour Array 3 (Monitoring) will quantitatively test for Carcinoembryonic Antigen, I-Fetoprotein and J human Chorionic Gonadotropin simultaneously.

REFERENCES

1. Primus FJ, Kelley EA, Hansen HJ, Goldenberg DM. "Sandwich"-Type Immunoassay of Carcinoembryonic Antigen in Patients Receiving Murine Monoclonal Antibodies for Diagnosis and Therapy. Clin Chem 1988;35:261.

2. Hansen HJ, Solving the Problem of Antibody Interference in Commercial "Sandwich"-Type Immunoassay of Carcinoembryonic Antigen. Clin Chem 1989;35:146.

3. Schroff RW, Foon KA, Beatty SM, Oldham RK, Morgan AC Jr. Human Anti-Mouse Immunoglobulin Responses in Patients Receiving Monoclonal Antibody Therapy. Cancer Res 1985;45:879.

4. Boscato LM, Stuart MC. Heterophilic Antibodies: A Problem for all Immunoassays. Clin Chem 1998;34:27.

 

Carcinoembryonic Antigen (CEA) Assay

INTENDED USE

The Evidence Investigator  CEA assay has been designed to measure qualitatively or quantitatively CEA in human serum samples.

CLINICAL SIGNIFICANCE

CEA (carcino-embryonic antigen), discovered in 1965 by Gold and Freedman, is a cancer antigen produced in response to malignant cells in adults but it is also present during foetal development. This is a high molecular weight non-mucinous glycoprotein secreted by the epithelial cells of the digestive tract, and originally thought to be present in colonic tumours only(1,2). However, it has now been found to occur in raised levels in patients with breast, ovarian, stomach, pancreatic and lung cancers, as well as other non-cancerous diseases(2,3,4).

The CEA test has been shown to be of value in the monitoring of patients with diagnosed malignancies who are undergoing therapy. Elevation of CEA following therapy is indicative of metastatic disease or residual disease. A persistent level of CEA during therapy suggests a poor therapeutic response. While decreases in levels of CEA during therapy is indicative of response to treatment and therefore favourable prognosis.

CEA is the second most common tumour marker in use(2). It can be used in screening, to aid with the early detection of prostate cancer, and in monitoring colorectal, breast, gastric and lung cancer patients post treatment. The discovery of raised CEA levels in the screening process suggests that carcinoma could be present and consequently other diagnostic tests can be performed to increase diagnostic accuracy(2). By combining CEA with other tumour markers the efficacy of the marker can also be improved(5).

In post therapy management, levels of CEA are monitored due to adjustments in marker level indicating the therapeutic success. Observing levels of CEA post therapy will reveal any residual disease, remission or relapse(4,5).

PRINCIPLE

The Evidence Investigator CEA assay is a sandwich chemiluminescent assay for the detection of CEA in human serum.

REFERENCES

1. Gold P, Freedman SO, Specific carcinoembryonic antigens of the human digestive system, Journal of Exploratory Medicine, 1965; 122: 467-481.

2. Wild D. (ed), The Immunoassay Handbook, second edition, Nature Publishing Group, London, Basingstoke, New York, 2001; 635-663.

3. Maxwell P, Carcinoembryonic antigen: cell adhesion molecule and useful diagnostic marker, British Journal of Biomedical Science, 1999; 56: 209-214.

4. Sell, S. Detection of Cancer by Tumor Markers in the Blood: A View to the Future. Critical Reviews in Oncogenesis, 1993; 4(4): 419-433.

5. Pathak K et al, Carcinoembryonic antigen: an invaluable marker for advanced breast cancer, Journal of Postgraduate Medicine, 1996; 42 (3): 68-71.

 

I -Fetoprotein (AFP) Assay

INTENDED USE

The Evidence Investigator  AFP assay has been designed to measure qualitatively or quantitatively AFP in human serum samples.

The AFP concentration in a given sample, when determined using assays supplied by different manufacturers, can vary due to diversity in assay methodology and reagent specificity. AFP results reported by the laboratory to the physician must identify the assay used as AFP values obtained using different assays cannot be used interchangeably. Before changing assays the laboratory must establish normal ranges and baseline values for patients being serially monitored.

CLINICAL SIGNIFICANCE

Alpha-fetoprotein (AFP), an oncofetal glycoprotein discovered by Abelev in 1963, was thought to occur in the presence of liver cancer only. However, the antigen is produced in response to various malignant cells in adults, and is also present during foetal development. In the foetus it is expressed in the liver, yolk sac and gastrointestinal tract, with levels peaking during gestation at 12-14 week(1). Soon after birth it is repressed, with levels decreasing to a stable adult level at 8 months(1,2). Consequently AFP is present in the maternal blood, with levels peaking at 32 weeks development and decreasing thereafter(1).

70-90% of patients with hepatocellular carcinoma have elevated AFP levels. Elevated AFP levels can also be detected in non malignant liver diseases, liver regeneration and during pregnancy as discussed above.

The use of assays for AFP determination in the screening of populations for hepatocellular carcinoma is not recommended. Although it may be of use in individuals known to be at a high risk of developing hepatocellular carcinoma.

The Evidence Investigator AFP assay should be used for serial measurement of AFP as an aid to the management of patients with hepatocellular carcinoma or germ cell carcinoma.

PRINCIPLE

The Evidence Investigator AFP assay is a sandwich chemiluminescent immunoassay for the detection of AFP in human serum.

REFERENCES

1. Wild D. (ed), The Immunoassay Handbook, second edition, Nature Publishing Group, London, Basingstoke, New York, 2001; 575-578, 635-663.

2. Trojan J, Raedle J, Zeuzem S, Serum tests for Diagnosis and Follow-up of Hepatocellular Carcinoma after treatment, Digestion, 1998; 59 (2): 72-74.

 

Human Chorionic gonadotropin (hCG) Assay

INTENDED USE

The Evidence Investigator  hCG assay has been designed to measure qualitatively or quantitatively hCG in human serum samples.

CLINICAL SIGNIFICANCE

Human Chorionic gonadotropin (hCG) is a glycoprotein which is composed of both an a and b subunit. The b subunit confers the characteristics of hCG, whilst the a subunit is common to other hormones involved with fertility.The early detection of pregnancy is possible due to hCG, since levels are present in higher concentration until 8-12 weeks when they then start to decrease. However, ovarian and testicular cancer also produces increased levels of hCG.

Currently the assay measures total JhCG levels in serum for the monitoring of ovarian and testicular carcinomas(2). However, elevated levels of hCG have also been found in breast, lung, small intestine and prostate cancers.

The assay is invaluable in patient monitoring following treatment as it can be used to indicate the success of the therapy. The changing levels of the marker are analogous to relapse or remission of disease.Therefore if levels decrease to the predetermined low level for hCG and remain at that level this signifies that the cancer has gone into remission. Similarly, very high levels mean that the cancer is still present and remission has not occurred, while rising levels suggest that there has been a relapse(1).

PRINCIPLE

The Evidence Investigator hCG assay is a sandwich chemiluminescent immunoassay for the detection of hCG in human serum.

REFERENCES

1. Wild D. (ed), The Immunoassay Handbook, second edition, Nature Publishing Group, London, Basingstoke, New York, 2001; 578, 580, 635-663.

2 Duffy MJ, McGing P, McSweeney J, Guidelines for the use of Tumour Markers, Scientific Committee Association of Clinical Biochemists in Ireland, 1998.