Gamma GT Diagnostic Kit Overview
Gamma GT Diagnostic Kit Overview
The GGT assay demonstrates high sensitivity and linearity, with a correlation coefficient of 0.999 in comparative studies and linearity up to 800 U/L. Beyond this, samples must be diluted and results multiplied by two, ensuring accurate high-range readings. The assay's sensitivity, allowing minimal absorbance drift, enables reliable detection of GGT activity even at low concentrations, enhancing its diagnostic utility across diverse pathologies .
Interference in GGT assays can be caused by anticoagulants in blood collection tubes, which inhibit GGT activity. Anti-epileptic drugs can falsely elevate GGT levels, leading to inaccurate results. Bilirubin up to 20 mg/dl and hemoglobin from 100-500 mg/dl show minimal interference, causing less than 5% and 5-7% depression in GGT activity, respectively. These interferences can partially distort the activity readings, therefore it is crucial to factor them into result interpretation and use appropriate controls .
The working reagent for GGT assays is prepared by mixing four volumes of Reagent 1 with one volume of Reagent 2. The prepared reagent should be stored at 2-8 °C, protected from light, and is stable up to the expiry date on the label. It must be discarded if turbid or if it exhibits an absorbance against water greater than 1.0 at 405 nm, indicating contamination or degradation .
Quality control in GGT testing involves using both normal and abnormal control sera to validate the assay process before testing patient samples. Controls should be implemented at least daily and after each calibration, following laboratory procedures and regulatory requirements. If control results fall outside the defined ranges, corrective measures must be taken. This regular confirmation ensures that patient results are accurate and reliable, protecting against procedural deviations or reagent inconsistencies .
The measurement of GGT activity is conducted using an enzymatic and kinetic method, standardized against the IFCC method. Monitoring the increase in absorbance at 405 nm due to the formation of 5-amino-2-nitrobenzoate ensures the quantification of GGT activity. Potential errors may arise from interference by anticoagulants in blood collection tubes, which inhibit GGT activity, or anti-epileptic drugs that may artificially elevate GGT levels. Turbidity, suggestive of contamination, and absorbance above a certain threshold also indicate reagent deterioration that can affect accuracy. Therefore, quality controls and proper handling procedures are critical to minimizing these sources of error .
Gamma-glutamyltransferase (GGT) is a key enzyme in glutathione metabolism and facilitates amino acid transport into cells. Clinically, GGT is used as a sensitive marker for liver and bile duct infections, as its activity rises more significantly than Alkaline Phosphatase (ALP) levels in such conditions. The highest increases in GGT levels are seen in intrahepatic or posthepatic biliary obstructions, and primary or metastatic liver cancers, reaching up to 30 times the normal levels. It is also valuable in monitoring pancreatic cancer, prostatic cancer, and hepatoma due to its level variations reflecting remission and recurrence. Moderate elevations occur in infectious hepatitis, cirrhosis, and hepatic steatosis, while chronic alcohol intake and certain drugs, like antiepileptics, can also elevate GGT serum levels .
The kinetic method in GGT testing involves measuring the change in optical density (∆OD) per minute at 405 nm after a one-minute incubation period, followed by monitoring over the next two minutes. Critical factors for its accuracy include maintaining a constant temperature at 37 °C, ensuring homogeneous mixing of reagents, and adhering to precise timing for the measurement intervals. These conditions prevent variability and ensure consistent kinetic activity readings .
Samples for GGT assays, specifically serum or lithium heparinized plasma, remain stable for seven days at 2-8 °C and for two months at -20 °C. Extended storage should be at -70 °C. These conditions ensure the integrity of the samples and the accuracy of subsequent assay results. Haemolysis and lipemia must be avoided as they may compromise sample quality, thus affecting the reliability of the measurements .
The reagent composition for the GGT test includes glycylglycine, at a concentration of 138 mmol/L (pH 7.70 at 37 °C), and GLUPA-C at 23 mmol/L. Handling precautions involve using clean or single-use laboratory equipment to avoid contamination. It is important to note that the reagents contain less than 0.1% sodium azide, which can form explosive metal azides with copper and lead plumbing. Thus, any discharge into the plumbing system must be followed by thorough rinsing with water. For professional users, a Material Safety Data Sheet (MSDS) provides further safety instructions .
The reference values for GGT levels differ between men and women; for men, the range is 8-61 U/L, while for women it is 5-36 U/L. These differences in reference ranges are clinically significant as they help in accurately diagnosing and monitoring conditions related to liver and bile duct functionality, ensuring gender-specific assessments aligned with normal physiological variations .