Evaluation of Clinical Usefulness of PREG-Q(TM) as a Screening Test for Pregnancy / 임상검사와정도관리

ABSTRACT

BACKGROUND: Among the many methods estimating the quantity of beta-hCG for pregnancy testing in urine, immunochromatography is one of most widely used semi-quantitative detection method for its convenience to use and also for its rapid result reporting system. PREG-Q(TM) is a newly introduced semi-quantitative immunochromatography method for detecting b-hCG. Clinical usefulness of PREG-Q(TM) was evaluated as a screening test for early pregnancy detection. METHODS: Accuracy, detection limit, cross-reactivity with various glycoprotein hormones, interference study, and comparison study using total 100 urine samples from pregnant (50 samples) and non-pregnant women (50 samples) was evaluated. RESULTS: All the 50 urine samples of pregnant women showed positive results, and another 50 urine samples of non-pregnant women showed negative results with PREG-Q(TM). The lower detection limit of PREG-Q(TM) was 25 mIU/mL and the result was not affected by addition of glycoprotein hormones tested. Interfering substance causing false negative or false positive results enrolled didn't affect the test results in this study. CONCLUSIONS: We conclude PREG-Q(TM) is an excellent test kit for pregnancy test, and is valuable especially for detecting early pregnancy.