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Download CLIS Urine Cassette - Legionella CLIA Packet Cover

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Download CLIS Urine Cassette - Legionella CLIA Packet Cover

Laboratory: Date Implemented:

    Address:

Sure-Vue Urine hCG Test Laboratory Procedure

I. Test Principle

    ?The Sure-Vue Urine hCG Test is a rapid chromatographic immunoassay for

    the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid

    in the early detection of pregnancy. The test utilizes a combination of

    antibodies including mouse monoclonal anti-hCG antibodies and goat

    polyclonal anti-hCG antibodies to selectively detect elevated levels of hCG.

    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 colored antibody conjugates and

    form a colored line at the test line region of the membrane. Absence of this

    colored line suggests a negative result. To serve as a procedural control, a

    colored line will always appear at the control line region if the test has been

    performed properly.

II. Specimen Collection/Treatment

A. Specimen: Urine Specimen.

    B. Collection Container: Clean and dry container.

    C. Specimen Storage: Urine may be stored refrigerated at 2-8? C for up to 48

    hours prior to testing. For prolonged storage, specimens

    may be frozen and stored below -20? C.

D. Handling Precautions: Handle all specimens as if they contain infectious agents.

     Observe established precautions against microbiological

    hazards throughout the procedure and follow the

    standard procedures for proper disposal of specimens.

CLSI Procedure Page 1 of 6 02959.00

    III. Reagents and Equipment

    A. Reagents and Materials Provided

    ? Test devices

    ? Disposable specimen droppers

    ? Package insert

B. Materials Required but not Provided

    ? Specimen collection container

    ? Timer

C. Storage and Stability

    Store as packaged in the sealed pouch at 2?-30?C. The test device is stable

    through the expiration date printed on the sealed pouch. The test device must

    remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the

    expiration date.

D. Quality Control

     Internal Procedural Controls

    Internal procedural controls are included in the test. A red line appearing in the

    control region (C) is the internal procedural control. It confirms sufficient

    specimen volume and correct procedural technique. A clear background is an

    internal negative background control. If the test is working properly, the

    background in the result area should be white to light pink and not interfere with

    the ability to read the test result.

    External Quality Control Testing

    It is recommended that a positive hCG control (containing 25-250 mIU/mL hCG)

    and a negative hCG control (containing "0" mIU/mL hCG) be evaluated to verify

    proper test performance. It is recommended that federal, state, and local

    guidelines be followed.

     External Quality Control Testing

    Remedial Actions

    When correct control results are not obtained, do not report patient results.

    Contact Technical Services at 800-637-3717.

E. Precautions

     For professional in vitro diagnostic use only. Do not use after the expiration

    date.

     The test device should remain in the sealed pouch until use.

     All specimens should be considered potentially hazardous and handled in

    the same manner as an infectious agent.

     The test device should be discarded in a proper biohazard container after

    testing.

    CLSI Procedure Page 2 of 6 02959.00

    IV. Test Procedure

    Specimen Collection and Handling:

    ? 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.

    ? 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.

    Test Procedure: Allow the test device, urine, and/or controls to equilibrate to room

    temperature (15-30?C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test

    device from the sealed pouch and use it as soon as possible.

    2. Place the test device on a clean and level surface. Hold the dropper vertically

    and transfer 3 full drops of urine (approx. 100µl) to the specimen well of the

    test device, and then start the timer. Avoid trapping air bubbles in the

    specimen well.

    3. Wait for the red line(s) to appear. The result should be read at 3 minutes. It is

    important that the background is clear before the result is read.

    V. Interpretation of Test Results

    POSITIVE*: Two distinct red lines appear. One line should be in the control

    region (C) and another line should be in the test region (T).

    NOTE: The intensity of the red color in the test line region (T) will vary depending on the concentration of hCG present in the specimen. However, neither the

    quantitative value nor the rate of increase in hCG can be determined by this

    qualitative test.

NEGATIVE: One red line appears in the control region (C). No apparent red or

    pink line appears in the test region (T).

    INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review

    the procedure and repeat the test with a new test device. If the problem persists,

    discontinue using the test kit immediately and contact Technical Support at (800)

    637-3717.

    VI. Limitations

    1. 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.

    2. 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.

    CLSI Procedure Page 3 of 6 02959.00

    3. Very low levels of hCG (less than 50 mIU/mL) are present in urine specimen

    shortly after implantation. However, because a significant number of first 5trimester 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. A number of conditions other than pregnancy, including trophoblastic disease

    and certain non-trophoblastic neoplasms including testicular tumors, prostate 6,7cancer, breast cancer, and lung cancer, cause elevated levels of hCG.

    Therefore, the presence of hCG in urine specimen should not be used to

    diagnose pregnancy unless these conditions have been ruled out.

    5. This test provides a presumptive diagnosis for pregnancy. A confirmed

    pregnancy diagnosis should only be made by a physician after all clinical and

    laboratory findings have been evaluated.

    VII. Expected 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 gestational age and between individuals.

The Sure-Vue Urine hCG has a sensitivity of 25 mIU/mL, and is capable of detecting

    pregnancy as early as 1 day after the first missed menses.

    VIII. Performance Characteristics

Accuracy

    A multi-center clinical evaluation was conducted comparing the results obtained

    using the Sure-Vue Urine hCG to another commercially available urine membrane

    hCG test. The study included 159 urine specimens: both assays identified 88

    negative and 71 positive results. The results demonstrated a 100% overall

    agreement (for an accuracy of > 99%) of the Sure-Vue Urine hCG when compared to the other urine membrane hCG test.

Reference hCG Method

     Positive Negative

    0 Positive 71

     Sure-Vue Urine hCG

    Negative 0 88

    CLSI Procedure Page 4 of 6 02959.00

Sensitivity and Specificity

    The Sure-Vue Urine hCG detects hCG at a concentration of 25 mIU/mL or greater.

    The test has been standardized to the W.H.O. Third International Standard. The

    addition of LH (300 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to

    negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) specimens showed no

    cross-reactivity.

Interfering Substances

    The following potentially interfering substances were added to hCG negative and

    positive specimens.

    Acetaminophen 20 mg/mL Caffeine 20 mg/mL

    Acetylsalicylic Acid 20 mg/mL Gentisic Acid 20 mg/mL

    Ascorbic Acid 20 mg/mL Glucose 2 g/dL

    Atropine 20 mg/mL Hemoglobin 1 mg/dL

    Bilirubin (urine) 2 mg/dL

     None of the substances at the concentration tested interfered in the assay.

    IX. References

    1. Batzer FR. “Hormonal evaluation of early pregnancy.” Fertil. Steril. 1980; 34(1):

    1-13

    2. Catt KJ, ML Dufau, JL Vaitukaitis. “Appearance of hCG in pregnancy plasma

    following the initiation of implantation of the blastocyte.” J. Clin. Endocrinol.

    Metab. 1975; 40(3): 537-540

    3. Braunstein GD, J Rasor, H. Danzer, D Adler, ME Wade. “Serum human chorionic

    gonadotropin levels throughout normal pregnancy.” Am. J. Obstet. Gynecol. 1976;

    126(6): 678-681

    4. Lenton EA, LM Neal, R Sulaiman. “Plasma concentration of human chorionic

    gonadotropin from the time of implantation until the second week of pregnancy.”

    Fertil. Steril. 1982; 37(6): 773-778

    5. Steier JA, P Bergsjo, OL Myking. “Human chorionic gonadotropin in maternal

    plasma after induced abortion, spontaneous abortion and removed ectopic

    pregnancy.Obstet. Gynecol. 1984; 64(3): 391-394 6. Dawood MY, BB Saxena, R Landesman. “Human chorionic gonadotropin and its

    subunits in hydatidiform mole and choriocarcinoma.” Obstet. Gynecol. 1977;

    50(2): 172-181

    7. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross. “Ectopic production of

    human chorionic gonadotropin by neoplasms.” Ann. Intern Med. 1973; 78(1): 39-

    45

    8. Sure-Vue Urine hCG Package Insert

    ?Sure-Vue is a registered trademark of Fisher Scientific Company, L.L.C. All rights

    reserved.

    CLSI Procedure Page 5 of 6 02959.00

Test Procedure Review

Supervisor Date Reviewed Supervisor Date Reviewed

CLSI Procedure Page 6 of 6 02959.00

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