AccuSpeed Pregnancy Test Card is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test uses two lines to indicate results. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The control line is composed of goat polyclonal antibodies and colloidal gold particles. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as as procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum or plasma as early as 7 to 10 days after conception. hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/ml by the first missed menstrual period and peaking in the 100,000-200,000 mIU/ml range about 10-12 weeks into pregnancy. The appearance of hCG in both the urine and serum or plasma soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.
AccuSpeed Pregnancy Test Card is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 25 mIU/ml. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, AccuSpeed Pregnancy Test Card shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
AccuSpeed Pregnancy Test Card is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of prgenancy.
Bring the pouch to room temperature (15-30°C) before opening it. Remove the cassette from the sealed pouch and use it as soon as possible.
Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approximately 120 ul) to the specimen well of the cassette, and then start the timer. Avoid trapping air bubbles in the specimen well.
Wait for the colored line(s) to appear. The result should be read at 3 minutes.
NOTE: A low hCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time; therefore, do not interpret the result after 10 minutes.
For professional in vitro diagnostic use only. Do not use after the expiration date.
The test should remain in the sealed pouch until ready to use.
All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
The used test should be discarded according to local regulations.
Store as packaged at room temperature or refrigerated (2-30°C). 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. Do not use beyond the expiration date.
Specimen Collection and Preparation: Urine Assay: A urine specimen must be collected in a clean and dry container. A first morning urine specimen is preferred since it generally contains the highest concentration of hCG; however, urine specimens collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
Specimen Storage: Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.
Materials: Materials provided: Test cassettes; Droppers; Package insert.
Materials required but not provided: Specimen collection containers; Timer.
INTERPRETATION OF RESULTS: POSITIVE: Two distinct colored lines appear. One line should be in the control line region and another line should be in the test line region. One line may be lighter than the other; they do not have to match. This means that the patient is probably pregnant.
NEGATIVE: One colored line appears in the control line region. No line appears in the test line region. This means that the patient is probably not pregnant.
INVALID: The result is invalid if no colored line appears in the control line region, even if a line appears in the test line region. The patient should repeat the test with a new test cassette.
QUALITY CONTROL: A procedural control is included in the test. A colored line appearing in the control line region is considered an internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative procedural control. If a background color appears in the result window and interferes with the ability to read the test result, the result may be invalid. It is recommended that a positive hCG control (containing 25-250mIU/ml hCG) and a negative hCG control (containing "0" mIU/ml hCG) be evaluated to verify proper test performance when a new shipment of tests is received.
LIMITATIONS: 1. AccuSpeed Pregnancy Test Card is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in hCG 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. Very low levels of hCG (less than 50mIU/ml) are present in urine specimens 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.
4. This test may produce false positive results. A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasm 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.
5. This test may produce false negative results. 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. In case pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.
6. This test provides presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
EXPECT 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 a gestational age and between individuals. AccuSpeed Pregnancy Test Card for Urine has a sensitivity of 25mIU/ml, and is capable of detecting pregnancy as early as 1 day after the first missed menses.
PERFORMANCE CHARACTERISTICS: Accuracy: A multi-center clinical evaluation was conducted comparing the results obtained using AccuSpeed Pregnancy Test Card to another commercially available urine hCG Rapid test. The study included 608 urine specimens, and both assays identified 377 negative and 231 positive results. The results demonstrated >99% overall accuracy of the AccuSpeed Pregnancy Test Card when compared to the other hCG Rapid Test. (See Table 1.)
Sensitivity and Cross-Reactivity: AccuSpeed Pregnancy Test Card detects hCG at concentration of 25mIU/ml or greater. The test has been standardized to the W.H.O. International Standard. The addition of LH (300mIU/ml), FSH (1,000mIU/ml), and TSH (1,000μIU/ml) to negative (0mIU/ml hCG) and positive (25mIU/ml hCG) specimens showed no cross-reactivity.
Precision: Intra-Assay: Within run precision has been determined by using 10 replicates of four specimens containing 25mIU/ml, 100mIU/ml, 250mIU/ml and 0mIU/ml of hCG. The negative and positive values were correctly identified 100% of the time.
Inter-Assay: Between-run precision has been determined by using the same four specimens of 25mIU/ml, 100mIU/ml, 250mIU/ml and 0mIU/ml of HCG in 10 independent assays. Three different lots of AccuSpeed Pregnancy Test Card have been tested. The specimens were correctly identified 100% of the time.
Interfering Substance: The following potentially interfering substances were added to hCG negative and positive specimens. (See Table 2.)
None of the substances at the concentration tested interfered in the assay.