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AimStick and AimStep Usage

AIM Stick AIM Step

Professional One-Step Early Detection Pregnancy Tests.

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SPECIMEN COLLECTION AND PREPARATION

The urine specimen must be collected in a clean, dry container, Specimens collected randomly may be used. However, the first morning urine generally contains the highest concentration of hormone. Urine specimens may be refrigerated (2° - 8°C) and stored up to 72 hours prior to assay. If specimens are refrigerated, they must be equilibrated to room temperature before testing. Urine samples exhibiting visible precipitates should be filtered, centrifuged, or allowed to settle (obtaining clear aliquots) before testing.

TEST PROCEDURE

aim stick test

Aim step test

Materials Provided:

Test strip or cassette containing monoclonal mouse-hCG colored conjugate and goat anti-hCG antibody pre-coated on a porous test membrane. A suitable clean urine collection cup or device (preferably glass) for the test procedure should be provided by the test subject. AimStick™ One-step test strip pre-packaged in foil pouch stamped with lot# and expiration date. AimStep™ test cassettes are prepackaged with a transfer pipette in fog pouch stamped with lot# and expiration date. Both tests are pre-calibrated at 20mIU/ml hCG sensitivity detection level. Both tests are FDA approved and CLIA waived for professional and OTC use.

DIRECTIONS FOR USE

Aim stick diagram
  • Allow specimen and test strip or cassette to reach room temperature (20° to 30°C) prior to testing.
  • Do not open the sealed pouch until you are ready to start the test.
  • Remove the test strip or cassette from the sealed foil pouch.
  • Be careful not to touch the test development areas of the test devices with your fingers or expose these areas to water or other fluids.
  • Hold the test strip at the top in a vertical position with the arrows pointing downward. Lower the test strip into the urine specimen. Do not immerse the test strip beyond the "Stop Line". See illustration at right.
  • Leave the test strip immersed for a minimum of 5 seconds. For the AimStep test card, using the pipette provided, drop 4-5 sample drops on the circle target area. If visible migration does not begin within one minute, add 2-3 additional drops.
  • Remove the test strip from the sample and place on a non-absorbent flat surface.
  • Read results for both test formats at 3-5 minutes. Do not attempt to interpret test results after 5 minutes.

TEST INTERPRETATION

Aim step diagram

The test is negative if only one band appears in the Control (C) Zone. The test is positive if two colored bands appear in the test panel (see the animated graphic to the right). One colored band will appear in the Test (T) Zone and one in the Control (C) Zone. Any colored band in the Test Zone should be considered a positive result if the band appeared within 3-5 minutes of starting the test procedure. The colored band in the Control Zone may be lighter or darker in color and/or intensity than the Test Zone band; this is not relevant to test interpretation, only the presence of a test band is important to test interpretation. The test is invalid if no band appears in the Control Zone even if a colored band appears in the Test Zone. This can be caused by not immersing the test strip for at least 5 seconds, immersing it beyond the "Stop Line", or with the cassette format, not adding enough sample to the sample well. Exposure to the test development area of the test devices to water or other fluids, or touching these areas can contaminate and/or prevent the proper operation of the test.

QUALITY CONTROL

Each test includes a built in quality and procedural control. Correct procedural technique and test strip performance is confirmed when a colored band appears at the Control Zone of the membrane.

LIMITATIONS OF THE TESTS

  • False negative results may occur when levels of hCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine should be collected 48 hours later and tested.
  • Elevated levels of hCG may be found in trophoblastic disease, choriocarcinoma, and embryonal cell carcinoma. Islet cell tumors may also produce hCG as well as other carcinomas.
  • Elevated levels of hCG may remain several weeks following normal pregnancy conclusion, delivery by cesarean section, spontaneous or therapeutic abortion.
  • Ectopic pregnancies may produce very low levels of hCG. If this condition is suspected further testing using a quantitative assay may be desirable.
  • In rare circumstances, abnormally high levels of system hCG, usually introduced through fertility injections or other artificial means can result in a false negative test directly attributed to the prozone effect. This possibility is extremely rare however and occurs in a fraction of 1% of normal procedures.

EXPECTED VALUES

Negative results are expected in healthy non-pregnant women and healthy men. Healthy pregnant women have hCG present. The amount will vary greatly with gestational age and between individuals. First morning urine specimens approximate hCG levels which reach 5 to 50 mIU/ml within 1 week of gestational age. AimStick PBD/AimStep tests can detect pregnancy as early as 1 day after a missed menses.

PERFORMANCE CHARACTERISTICS

Accuracy:
A multi-center clinical evaluation was conducted comparing the results obtained using AimStick PBD Pregnancy and another commercially available membrane test. The study included 150 specimens and both assays found 72 negative and 78 positive results. AimStick PBD Pregnancy showed a 100% concordance with the other commercially available membrane test.

SENSITIVITY AND SPECIFICITY

AimStick PBD Pregnancy detects hCG concentrations of 20 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard of mIU or standard international unit. The addition of LH (300 mIU/ml), FSH (1000 mIU/ml), and TSH (1000 IU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity.

PRECAUTIONS

  1. The test strip or card should remain in the sealed pouch until ready for use. Once the sealed pouch has been opened, the test is good for 90 days only.
  2. All urine specimens should be considered potentially hazardous and handled in the same manner as an infectious waste agent.
  3. The test strip should be discarded in a proper container after testing.
  4. Any positive test should be confirmed with your healthcare provider immediately.

STORAGE AND STABILITY

The test strips should be stored at room temperature (15° to 30° C) for the duration of the shelf-life. The test strip must remain in the foil wrap or fog pouch until ready for use. Once the wrap or pouch has been opened the test strips are good for 90 days only.

INTERFERING SUBSTANCES

The following potential interfering substances were added to hCG negative and positive samples.

Acetaminophen
20 mg/dl
Gentisic Acid
20 mg/dl
Atropine
20 mg/dl
Caffeine
20 mg/dl
Ascorbic Acid
20 mg/dl
Hemoglobin
1 mg/dl
Acetylsalicylic Acid
20 mg/dl
Glucose
2 g/dl

None of the substances above at the concentration shown interfered with test results.

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