Related Experiment Videos
A multicentric evaluation study of an indigenously prepared cost effective prototype pregnancy test
M I Khatkhatay1, M P Desai, U M Donde
1Institute for Research in Reproduction (ICMR), Bombay.
The Indian Journal of Medical Research
|March 1, 1996
Summary
A new pregnancy detection kit, Preglisa, shows high accuracy in detecting human chorionic gonadotropin (hCG). This cost-effective kit is recommended for early pregnancy diagnosis in India.
Area of Science:
- Reproductive biology
- Medical diagnostics
- Biochemistry
Background:
- Early pregnancy detection is crucial for timely prenatal care.
- Existing diagnostic methods have limitations in accessibility and cost.
- Development of reliable, indigenous diagnostic tools is essential.
Purpose of the Study:
- To evaluate the performance of an indigenously developed urinary human chorionic gonadotropin (hCG) detection kit, Preglisa.
- To compare Preglisa's accuracy against established pregnancy confirmation methods.
- To assess the clinical utility of Preglisa in the Indian context.
Main Methods:
- Multicentric evaluation across 12 centers.
- Comparison of Preglisa results with ultrasonography, clinical judgment, and serum beta-hCG levels.
- Performance assessment against non-immunological tests and commercially available kits.
Main Results:
- Preglisa demonstrated high sensitivity (98.7%) and specificity (98.05%) compared to non-immunological tests (n=382).
- Compared to commercial kits (n=155), Preglisa showed 97.9% sensitivity, 97.2% specificity, and 97.94% accuracy.
- The kit has a sensitivity of 300 mIU/ml and is cost-effective.
Conclusions:
- Preglisa is a highly accurate and reliable indigenous pregnancy detection kit.
- The kit meets general requirements for early pregnancy detection (35 days post-LMP) in India.
- Preglisa offers a cost-effective diagnostic solution for pregnancy confirmation.