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OneStep Midstream Urine hCG Pregnancy Test

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					          OneStep Midstream Urine hCG Pregnancy
                         InstaTest
                                               Catalog #114360

INTRODUCTION
OneStep Midstream Urine hCG Pregnancy InstaTest is a test kit for the determination of hCG
(Human Chorionic Gonadotropin) in urine specimens. This test kit is used to obtain a visual,
qualitative result for early detection of pregnancy at home.




                               Cap             Absorbent Sampler Show Window                                  Handle

TEST PROCEDURE
1. To begin testing, open the sealed pouch by tearing along the notch. Remove test kit from the
   pouch.
2. Hold the round end of cover with one hand. Use the other hand to pull out the test device
   and expose the absorbent.
3. Point the absorbent tip downward; place the absorbent tip in urine stream for at least 10
   seconds to be thoroughly wet. Otherwise, you can collect your urine into a clean cup and dip
   half of the absorbent pad into the urine for at least 10 seconds.

                               Do not stream pass the arrow end




4. Re-cap the device and wait for color bands to appear. Depending on the concentration of
   hCG, positive result may be observed in as short as 40 seconds. However, to confirm
   negative results, the complete reaction time (5 minutes) is required. Do not read results after
   10 minutes.

INTERPRETATION OF RESULTS
 Negative: Only one color band appears on the control
   regions. No apparent band on the test region. There is no                                            Not Pregnant
   pregnancy.

    Positive: Distinct color bands appear on the control and test
     regions. Both test line and control line indicates that you are                                       Pregnant
     pregnant. Color intensity of the test bands may vary.
     Different stages of pregnancy have different concentration of
     hCG level.

    Invalid: No visible band at all. Repeat test with a new test kit.

STORAGE AND STABILITY
The test kit can be stored at room temperature (18 to 30 C) in the sealed pouch for duration of
shelf life. The test kits should be kept away from direct sunlight, moisture and heat.

PRECAUTION
1. For in vitro diagnostic use only.
2. Do not use test kit beyond expiry date.
                          Cortez Diagnostics, Inc. • 23961 Craftsman Rd., Suite D, Calabasas, CA 91302
Telephone: (818) 591-3194 • Fax: (818)591-0393 • email: onestep@rapidtest.com • website: http://www.rapidtest.com
3. The test device should not be reused.

Limitations of the Test
1. The InstaTest 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 InstaTest 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
InstaTest 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 InstaTest was detected).


Rev1/02




                          Cortez Diagnostics, Inc. • 23961 Craftsman Rd., Suite D, Calabasas, CA 91302
Telephone: (818) 591-3194 • Fax: (818)591-0393 • email: onestep@rapidtest.com • website: http://www.rapidtest.com