Rapid-VIDITEST hcg serum&urine Card

Transcription

1 Rapid-VIDITEST hcg serum&urine Card One step Pregnancy test. Instruction manual Producer: VIDIA spol. s r.o., Nad Safinou II 365, Vestec, Jesenice, Czech Republic, Tel.: , INTENDED USE: The Rapid-VIDITEST hcg serum&urine Card is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin in human urine and serum specimens to aid in the early detection of pregnancy. INTRODUCTION: Chorionic gonadotropin is a hormone found in the female body during the early months of pregnancy (it is produced in the placenta). It is in fact the pregnancy indicator looked at by the over the counter pregnancy test kits, as due to its origin it is not found in the body at any other time. Blood and urine levels of this hormone will become noticeable as early as seven days after conception. The level will rise evenly, reaching a peak at approximately two to three months into gestation. After this point, the hormone level will drop gradually until the point of birth. PRINCIPLE: The Rapid-VIDITEST hcg serum&urine Card is a qualitative immunoassay for the detection of human Chorionic Gonadotropin in human serum or urine samples. The membrane is pre-coated with monoclonal antibodies against hcg hormone on the test line region. During testing, the sample reacts with the particle coated with anti-hcg antibodies which was pre-dried on the test strip. The mixture moves upward on the membrane by capillary action. In the case of a positive result the specific antibodies present on the membrane will react with the mixture sample and generate coloured lines. A red coloured band always appears in the control line and serves as verification that sufficient volume was added, that proper flow was obtained and as an internal control for the reagents. MATERALS PROVIDED: - Rapid-VIDITEST hcg serum&urine Card tests with plastic pipettes - Instructions for use 1

2 MATERIALS REQUIRED BUT NO PROVIDED: - Specimen collection container - Disposable gloves - Timer SPECIMEN COLLECTION AND PREPARATION: Urine assay: The urine specimen may be collected in a clean, dry, plastic or glass container. For early determination of pregnancy, the first morning specimen of urine is recommended since it usually contains the highest concentration of hcg. However, any urine specimen is suitable for testing. Perform testing immediately after collection. Urine specimens may be stored at 2 to 8 ºC ( ºF) for up to 48 hours. Label the urine collection container. Serum assay: Collect blood aseptically by venipuncture into a clean tube without anticoagulants. Permit blood to form a clot for twenty to thirty minutes at room temperature. Centrifuge to obtain clear supernatant and transfer it into a clean plastic or glass tube. PROCEDURES: Allow the tests and samples to reach to room temperature (15-30ºC/59-86ºF) prior to testing. Do not open pouches until ready to perform the assay. 1. Open the sealed pouch. Remove the Rapid-VIDITEST hcg serum&urine Card from its sealed pouch and use it as soon as possible. Use a separate device for each sample. 2. Dispense exactly 5 drops or 150 ul of serum or urine sample into the specimen well (S). Start the timer. Read the result at 5-10 minutes after dispensing the sample. Use a separate pipette for each sample. Depending on the concentration of hcg in the test specimen, positive results may be observed in as soon as 1 minute. Do not read results after more than 10 minutes. 2

3 INTERPRETATION OF RESULTS: POSITIVE NEGATIVE INVALID INVALID POSITIVE: Two lines appears across the central window, in the result line region (red test line marked with the letter T) and in the control line region (red control line marked with the letter C). NEGATIVE: Only one red band appears across the control line region marked with the letter C (control line). INVALID: A total absence of the control coloured band regardless the appearance or not of the test line. Note: Insufficient specimen volume, incorrect procedural techniques or deterioration of the reagents are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit and contact you local distributor. NOTES ON THE INTERPRETATION OF RESULTS: The intensity of the red coloured band (test line) in the result line region (T) will vary depending on the concentration of hormone in the specimen. However, neither the quantitative value, nor the rate of increase in hormone can be determined by this qualitative test. QUALITY CONTROL: Internal procedural controls are included in the test: A red line appearing in the kontrol line region (C). It confirms sufficient specimen volume and correct procedural technique. 3

4 LIMITATIONS: 1. Rapid-VIDITEST hcg serum&urine Card will only indicate the presence of hormone in the specimen (qualitative detection). Neither the quantitative value nor the rate of increase in hormone concentration can be determined by this test. 2. Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg. If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested. 3. False negative results may occur when the levels of hcg are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested. 4. Very low levels of hcg (less than 50 miu/ml) are present in urine specimen shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later. 5. A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg. Therefore, the presence of hcg in urine should not be used to diagnose pregnancy unless these conditions have been ruled out. 6. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated. EXPECTED VALUES: Negative results are expected in healthy non-pregnant women and healthy men. Healthy pregnant women have hcg present in their urine and serum specimens. The amount of hcg will vary greatly with gestational age and between individuals. The Rapid-VIDITEST hcg serum&urine Card has a sensitivity of 25 miu/ml (based on WHO 3 nd IRP 75/537), and is capable of detecting pregnancy as early as 1 day after of the missed menstrual period. PERFORMANCE CHARACTERISTICS: Sensitivity and specificity The Rapid-VIDITEST hcg serum&urine Card detect hcg hormone levels of 25 miu/ml (based on WHO 3 nd IRP 75/537) in urine and serum samples. Cross-Reactivity The cross reactivity of hcg test kits was evaluated with hcg homologous hormone. Homologous hormones FSH, LH and TSH were added to serum or urine samples containing hcg at concentration of 0, 20 or 100 miu/ml. No cross reactivity was observed in the study. STORAGE AND STABILITY: Store as packaged in the sealed pouch either at refrigerated or room temperature (2-30ºC/36-86ºF). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. Do not freeze. 4

5 PRECAUTIONS: - For professional in vitro diagnostic use only. - Do not use after expiration date. - The test should remain in the sealed pouch until use. - Do not use the test if pouch is damaged. - Follow Good Laboratory Practices, wear protective clothing, use disposal gloves, do not eat, drink or smoke in the area. - All the specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. - The test should be discarded in a proper biohazard container after testing. - The test must be carried out within 2 hours of opening the sealed bag. REFERENCES: 1. GOEBELSMANN U. Protein and steroid hormones in pregnancy. J Reprod Med 1979; 23: HORNE C., Nisbet A.D.: Pregnancy proteins: A review. Invest. Cell. Pathol. 1979; 2: DAWOOD M.Y., BB Saxena, R. Landesman Human chorionic gonadotropin and its subunits in hydatidiform mole and choriocarcinoma, Obstet. Gynecol SYMBOLS FOR IVD COMPONENTS AND REAGENTS: In vitro diagnostic device Use by Batch code Manufacturer 5

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