INSTRUCTIONS: PREGNANCY TESTS: Home Pregnancy Urine Test – Midstream
The OneStep Midstream hCG Test is an immunochromatographic assay designed for qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
SUMMARY AND EXPLANATION OF THE TEST Human chorionic gonadotropin is a glycopeptide hormone produced by the placenta during pregnancy. The appearance and rapid rise in the concentration of hCG in the woman’s urine makes it a good pregnancy marker. Usually, concentration of hCG in urine is at least 25 mIU/ml as early as seven to ten days after conception. The concentration increases steadily and reaches its maximum between the eighth and eleventh weeks of pregnancy. The Midstream hCG Test is an immunochromatographic assay which utilizes both conventional and monoclonal antibodies to selectively identify hCG in urine.
PRINCIPLES OF THE TEST The immunochromatographic device contains a unique set of dye-conjugated and immobilized monoclonal and polyclonal antibodies used to produce a distinctive visual pattern indicating elevated concentration of hCG (≥25 mIU/ml) in the test sample, in approximately five minutes. In the test procedure, the liquid sample is allowed to migrate through the absorbent area. If hCG is present, labeled antibody-dye conjugate binds it, forming an antibody-antigen complex. As the reaction mixture continues to flow along the test membrane, the complex binds to the anti-hCG antibody in the test (T) zone of the membrane, and produces a pink-rose color band. Unbound conjugate binds to the reagents immobilized in the control © zone producing a pink-rose color band, demonstrating proper performance of the test.
REAGENTS AND MATERIALS PROVIDED 1. Testing Device.
MATERIALS REQUIRED BUT NOT PROVIDED 2. Clock or timer.
STORAGE CONDITIONS
Store the kit below 28°C; do not freeze. Optional liquid components require refrigeration (4°C). Refer to individual expiration dates of components for stability.
PRECAUTIONS 1. Do not use test after the expiration dates. 2. Dispose of used testing devices in a proper biohazard container. 3. If testing device has been stored in a refrigerator, allow them to warm to room temperature before performing the test.
SPECIMEN TESTING First morning urine usually contains the highest concentration of hCG and is therefore the best sample when performing the urine test. However, randomly collected urine specimens may be used.
QUALITY CONTROL The use of controls is recommended to verify proper kit performance. Quality control reagents (optional kit components) should be tested according to quality control requirements established by the testing laboratory. Use controls in the same procedure as specimens.
TEST PROCEDURE 1. Remove the test stick from its foil pouch by tearing at the notch. 2. Take the cap off the test stick as shown in figure 1. 3. To perform the test, turn the test stick so that the purple side of the handle is facing you, and the twin absorbent windows are located on the bottom of the test stick (as shown in Figure 2) With the purple side of the test stick facing you and the twin absorbent windows pointing in a downward direction, hold the test stick in your stream of urine (hold it for at least six seconds so that adequate urine goes into the absorbent windows (shown in figure 3)
Seal the twin absorbent windows with the cap. 1. Turn the stick over with the purple side down and set it on the table. 2. You should see a rose-pink color moving across the viewing windows as the test begins to work. 3. In 2 to 5 minutes, a rose-pink color band will appear in the small window to show that the test is complete. 4. Read the viewing windows and interpret the results as shown in figure 4.
INTERPRETATIONS OF THE TEST After you have completed the test, whether you are pregnant or not, a rose pink color band will apparent in the small control window. This indicates that the OneStep Midstream test is working properly. Now you can read your results in the large test window.
Positive: After the urine has been in the test stick for five minutes, you can conclude that you are pregnant if a rose -pink color band appears in the large test window. Negative: You can conclude you are not pregnant if no rose-pink color band is seen in the large test window within 5 minutes. Note: Even if a faint rose-pink color band is visible in the test window at five minutes, the test is positive. IMPORTANT: IF there is no color band is the small control window you may not have followed the instructions correctly or the test stick may have deteriorated. Reread the instructions carefully and repeat the test using another Insta Test OneStep Midstream test.
LIMITATIONS OF THE TEST 1. The hCG MidtreamTest is for in vitro diagnostic use only. 2. Besides pregnancy, elevated concentrations of hCG may be found in patients with both gestational and non-gestational trophoblastic diseases. These conditions should be ruled out in the interpretation of hCG levels to establish a diagnosis of pregnancy. 3. Although is very accurate in detecting pregnancy, a low incidence of false results can occur. Consult with a physician if you obtain unexpected or inconsistent results. 4. A normal pregnancy cannot be distinguished from an ectopic pregnancy based on hCG levels alone. Also, a spontaneous miscarriage may cause confusion in interpreting the test results. 5. As with all diagnostic tests, a definitive diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. 6. A negative result from a specimen collected from a woman in very early pregnancy may be due to an unusually low concentration of hCG. In such cases, the test should be repeated on a fresh specimen obtained approximately two days later. 7. A urine sample may be too diluted and thus may not contain a representative concentration of hCG. If a negative result is obtained with a urine specimen and pregnancy is still suspected, obtain a first morning urine specimen and re-test.
PERFORMANCE CHARACTERISTICS Sensitivity hCG Test will detect hCG in urine at concentrations 25 mIU/ml or greater. This sensitivity level has been confirmed with hCG standards (25, 50, 100, 1000, 450,000, and 900,000 mIU/ml) in urine. Occasionally, specimens containing less than 25 mIU/ml hCG can also give positive results. Specificity Related hormones potentially cross-reactive with anti-hCG were added to hCG-free urine samples in the following concentrations: LH: 50, 100, 300, and 500 mIU/ml; FSH: 50, 100, 500, and 1000 mIU/ml; TSH: 100, 500, and 1000 mIU/ml. In addition, these concentrations of LH, FSH and TSH were added to urine samples containing hCG at 25 and 450,000 mIU/ml. In all cases the results of hCG testing were not affected by added glycoprotein hormones (no cross reactivity of was detected).
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Medimpex Inc.
