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Automated enzyme immunoassay for lutropin with the Abbott IMx analyzer
K A Ford1, H N Baker, J G Baar
1Department of Physiological Diagnostics, Abbott Diagnostics Division, Abbott Laboratories, Abbott Park, IL 60064.
Insights
A new automated enzyme immunoassay for human lutropin (LH) offers rapid, sensitive detection in about 40 minutes. This assay demonstrates minimal cross-reactivity and interference, making it suitable for reproductive pathology diagnostics.
Area of Science:
- Clinical Chemistry
- Immunoassay Technology
- Reproductive Endocrinology
Background:
- Accurate measurement of human lutropin (LH) is crucial for diagnosing reproductive disorders.
- Existing immunoassay methods may have limitations in terms of speed, sensitivity, or suitability for routine laboratory use.
Purpose of the Study:
- To describe an automated enzyme immunoassay for human LH.
- To evaluate the performance characteristics of this new assay for clinical application.
Main Methods:
- Development and validation of an automated enzyme immunoassay for human LH on the Abbott IMx analyzer.
- Assessment of assay sensitivity, specificity (cross-reactivity), interference, precision (CVs), and correlation with established methods.
Main Results:
- The assay provides results within 40 minutes with a sensitivity of 0.25 int. units/L.
- Negligible cross-reactivity with follitropin, thyrotropin, and human choriogonadotropin was observed.
- No significant interference from bilirubin, hemoglobin, or triglycerides.
- Excellent precision with intra-, inter-, and total assay CVs ≤ 7.94%.
- High correlation (r = 0.98) with RIA and MAIAclone assays.
Conclusions:
- The automated enzyme immunoassay for human LH is a rapid, sensitive, and reliable method.
- Its performance characteristics make it well-suited for small to medium-sized laboratories.
- This assay can aid in the clinical diagnosis of reproductive pathology.
Abstract:
An automated enzyme immunoassay for human lutropin for use with the Abbott IMx analyzer is described. The assay provides results in approximately 40 min with a sensitivity of 0.25 int. units of LH per liter for up to 23 serum or plasma samples. Cross-reactivity with follitropin (2000 int. units/L) and thyrotropin (2 int. units/L) was negligible; it was 0.016% with human choriogonadotropin (1 X 10(6) int. units/L). There was no interference by high concentrations of bilirubin (0.5 g/L), hemoglobin (7.50 g/L), or triglycerides (13.5 g/L). Intra-, inter-, and total assay CVs were less than or equal to 3.75%, less than or equal to 7.1%, and less than or equal to 7.94%, respectively. Values obtained with the IMx correlated well (r = 0.98, n = 194) with values obtained with Diagnostic Products' LH Double Antibody RIA, and Serono's LH MAIAclone assay. This assay should be useful for small to medium-size laboratories involved in the clinical diagnosis of reproductive pathology.