Direct Monoclonal Pregnancy Kit

DIRECT MONOCLONAL LATEX PREGNANCY TEST KIT

Catalogue Number Kit Size DMP/2050 50 test 4. Using the pipette-stirrers provided, place one drop of the DMP/2100 100 test urine specimen(s) onto the remaining circle(s) of the agglutination slide. INTRODUCTION 5. Shake and re-suspend the Pregnancy latex reagent. Add The Direct Monoclonal Latex Pregnancy Test Kit is designed one drop to each of the test circles of the agglutination for the qualitative detection of human chorionic slide. gonadotrophin in urine. 6. Stir with individual pipette-stirrers and spread mixture Human chorionic gonadotrophin (HCG) is a glycoprotein over entire area of the test circle. hormone secreted by the developing placenta beginning 7. Gently rock the agglutination test slide for two minutes shortly after fertilisation. At the time of the first missed and observe the test circles for agglutination. Interpret menstrual period, HCG concentrations in serum and urine are results at two minutes. Extended incubation may result in about 100mlU/ml and double in concentration every 1.2 to 2 evaporation and erroneous results. days. Peak levels of over 100,000 mlU/ml HCG are seen late in the first trimester of pregnancy (1-4). The early appearances INTERPRETATION OF RESULTS: of HCG in urine following conception have been made in the 1. Positive result: agglutination occurs within two minutes. marker of choice in the early detection of pregnancy. 2. Negative result: agglutination does not occur within two The Direct Pregnancy assay is based upon the latex minutes. agglutination reaction between latex particles coated with anti-HCG antibodies and HCG present in the test specimen. LIMITATIONS OF PROCEDURE: The presence of HCG in the urine specimen results in the 1. This test is for use with urine only. Serum should not be formation of an agglutination matrix which is visually used. differentiated from the non-agglutinating negative control. 2. Urine HCG levels of greater than 200 mlU/ml are required for positive results. KIT PRESENTATION 3. A number of conditions other than pregnancy, including 1. Pregnancy latex reagent (yellow label): a suspension of trophoblastic diseases and certain non-trophoblastic antibody coated latex particles in a buffer containing neoplasms, can result in elevated urine HCG levels(5,6). 0.1% sodium azide. These diagnoses should be considered if consistent with 2. Positive pregnancy control (red label) with preservative. the clinical evidence. 3. Negative Pregnancy control (blue label) with preservative 4. Pipette-stirrers, single use specimen dropper/stirrers.. EXPECTED VALUES: 5. Agglutination slide. Healthy men and healthy non-pregnant females do not have HCG levels detected by this method. Urine HCG levels of 200 ADDITIONAL REQUIREMENTS mlU/ML can be reached a few days after missed 1. Specimen collection containers for urine. menstruation(1). 2. Two minute timer. PERFORMANCE CHARACTERISTICS: STORAGE AND STABILITY: 1. The sensitivity of the Plasmatec Direct Monoclonal The components of this kit are stable until the expiration date Pregnancy Latex Test Kit has been set to 200mlU/ML of the kit when stored at 2-8C. when calculated against the WHO Second International Standard. SAFETY PRECAUTIONS: 2. Accuracy of at least 99% is obtained under actual clinical This test is for in vitro diagnostic use only. The reagents must conditions when compared against standard quantitative be stored at 2-8C when not in use. HCG methods.

SPECIMEN COLLECTION: References: Urine specimens must be collected without preservatives in a 1. Batzer,F.R.Fertility and Sterility, Vol 34, 1 (1980) clean dry container. First morning urine usually contains the 2. Catt, K.J., Dufan M.L. Vaitukaitis, J.L. highest concentration of HCG, however urine collected at any J.Clin.Endocrinal Metab., Vol 40, 537 (1975) time during the day may be used. 3. Braunstein, G.D., Rasor, J, Adler, D. Danzer, H. and Wade, M.E. Am.J.Obstet. Gynecol, Vol 126, 678 (1976) ASSAY PROCEDURE: 4. Lenton, E.A. Neal, L.M. Sulaiman, R. Fertility and 1. Bring the reagents and specimen to room temperature Sterility, Vol 37, 773 (1902) before use. 5. Daewood, M.Y., Saxena, B.B., Landesman, R.Ob. Gyn., 2. Place one drop of the Negative Pregnancy Control onto a Vol 126,678 (1980) circle of the agglutination slide. 6. Braunstein, G.D., et al Ann.Med., vol 78, 39 (1973) 3. Place one drop of the Positive Pregnancy Control onto an adjacent circle of the agglutination slide.