An immunoassay for the rapid and qualitative detection of HCG in urine. For in vitro diagnostic use only.
Materials Supplied: Test cassette, Pipette, Package insert.
Materials Required but not Supplied: Specimen collection container, Timer.
Human chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. In normal pregnancy, HCG can be detected in serum as early as 7 days following conception, doubling every 1.3 to 2 days and reading 100mIU/ml at the first missed menstrual period. The appearance of HCG soon after conception and its subsequent rise in concentration during early gestational growth make it an excellent marker for the early detection of pregnancy.
HCG Pregnancy Urine Test Kit (Mini Cassette) is a qualitative, sandwich dye conjugate immunoassay for the determination of human HCG in urine. The method employs a unique combination of monoclonal and polyclonal antibodies to selectively identify HCG in test samples with a high degree of sensitivity. In less than 5 minutes, elevated levels of HCG as low as 25mIU/ml can be detected.
Principle: As the tested sample diffuses through the absorbent test strip, the labeled antibody-dye conjugate binds to the HCG in the specimen forming an antibody-antigen complex. This complex binds to the anti HCG antibody in the positive reaction zone and produces a pink-rose color band when HCG concentration is greater than 25mIU/ml. In the absence of HCG, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative zone. Unbound conjugate binds to the reagents in the negative control zone, producing a pink-rose color band, demonstrating that the reagents and test cassette are functioning correctly.
Performance Characteristics: Sensitivity and specificity: HCG Pregnancy Urine Test Kit (Mini Cassette) detects urinary HCG concentrations greater than 25mlU/ml as indicated by the development of two lines on the test cassette. Urine from healthy men and non-pregnant women will normally show undetectable levels of HCG when tested on HCG Pregnancy Urine Test Kit (Mini Cassette). The test will yield a positive result on the first day of missed menstrual period.
Specificity of the HCG Pregnancy Urine Test Kit (Mini Cassette) was determined from cross reaction studies with known amount of Luteinizing Hormone (hLH), Follicle Stimulating-Hormone (hFSH), and Thyroid Stimulating Hormone (hTSH), 500mIU/ml hLH, 1000mIU/ml hFSH and 1000mIU/ml hTSH. All gave negative results.
Menopausal Urines: A study was performed using urine specimens from 20 postmenopausal women. These specimens were chosen because urine from postmenopausal women frequently interfere with pregnancy tests due to cross reactivity with other gonadotropin hormones. All 20 urine specimens were negative when tested with HCG Pregnancy Urine Test Kit (Mini Cassette). Potentially interfering substances were added to urine which had HCG levels of 0 and 25mIU/ml. In each case, no interference with the expected HCG Pregnancy Urine Test Kit (Mini Cassette) results were observed.
Standardization: The HCG Pregnancy Urine Test Kit (Mini Cassette) has been standardized to World Health Organization First International Reference Preparation (IRP 75-537).
Accuracy: A study was performed using a total of 150 positive and negative urine specimens. These specimen were assayed with HCG Pregnancy Urine Test Kit (Mini Cassette) and our Visual Pregnancy Test and it showed identical result.
Interference testing: The substances as follows were added in HCG free and 25mIU/ml HCG spiked urine samples. None at concentration tested interfered in the assay.
Acetaminophen 20 mg/dl; Acetylsalicylic Acid 20 mg/dl; Ascorbic Acid 20 mg/dl; Atropine 20 mg/dl; Caffeine 20 mg/dl; Gentesic Acid 20 mg/dl; Glucose 2 g/dl; Hemoglobin 1 mg/dl.
For the rapid detection of human chorionic gonadotropin (HCG) in urine. This test is used to obtain a visual qualitative result.
For in vitro diagnostic use only.
Warning: the reagents in this kit contain sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of such reagents, always flush with large volumes of water to prevent azide build up.
The test kit can be stored at temperatures between 2-30°C in the sealed pouch till the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.
Specimen Collection: The urine specimen must be collected in a clean dry container either plastic or glass, without preservative. Specimens collected at any time may be used. However the first morning urine generally contains the highest concentration of hormone. Urine specimen may be refrigerated (2-8°C) and stored up to 72 hours prior to use. If samples are refrigerated, they must be equilibrated to room temperature before testing. Urine samples exhibiting visible precipitates should be filtered, centrifuged, or allowed to settle and clear aliquots obtained for testing.
Assay Procedure: To begin testing, open the sealed pouch by tearing along the notch. Remove the test cassette from the pouch.
1. Draw 0.2ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette.
2. Wait for the coloured bands to appear. Depending on the concentration of HCG in the test specimen, positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time 5-10 (minutes) is required. Do not read results after 10 minutes.
Interpretation of Results: Negative: Only one color band appears on the control region. No apparent band on the test region. This indicates that no pregnancy has been detected.
Positive: Distinct color bands appear on the control and test regions. Presence of both test line and control line indicate that you are probably pregnant. The color intensity of the test bands may vary since different stages of pregnancy have different concentrations of HCG hormone.
Invalid: No visible band at all or no band appears on the control (C) region. Repeat with a new test kit. If the problem persists, discontinue using the test kit immediately and contact the local distributor.
Quality Control: Each test cassette has its own built-in quality control indicator. If after performing the test and no line is visible on test cassette, the test cassette may have deteriorated. Repeat the assay using a new cassette.
V04CX - Other diagnostic agents ; Used as diagnostic agents.