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HCG Gold Rapid Screen Test


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									                                                                                                                                                      Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).
                                                             HCG TEST CARD                                                                            Negative: Only one colored band appears on the control region (C). No colored band in the test region(T).
                                                                                                                                                      Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.

           FOR THE QUALITATIVE DETECTION OF HUMAN CHRONIC GONADOTROPIN                                                                                LIMITATION
                                 IN URINE SPECIMENS                                                                                                   1. The QuickView HCG Test Card is a qualitative assay and is not intended for any use other than for the early detection of pregnancy.
                                                                                                                                                      2. In addition to the normal elevations of HCG produced in pregnancy, a number of conditions including trophoblastic disease, proteinuria,
                                                                                                                                                         hematuria, choriocarcinoma, ovarian and testicular teratomas cause elevated levels of HCG. These diagnosis should be considered if
                                                       Catalog Number: 73002                                                                             appropriate to the clinical evidence.
                                                                                                                                                      3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the
                                               For In Vitro Diagnostic Use Only                                                                          physician after all clinical and laboratory findings have been evaluated.

INTENDED USE                                                                                                                                          PERFORMANCE CHARACTERISTIC
The QuickView HCG Test Card is a chromatographic immunoassay for the early detection of human chronic gonadotropin (HCG) in urine                     Sensitivity:
specimens.                                                                                                                                            The analytical sensitivity of QuickView HCG Test Card has been set at 25mIU/ml. A urine specimen contains HCG concentrations equal to or
                                                                                                                                                      greater than 25mIU/ml HCG gives a positive result. The sensitivity was also evaluated by a panel of urine samples spiked with HCG to the
INTRODUCTION                                                                                                                                          concentrations of 0, 25, 50, 100, 500mIU/ml. The results are shown in Table 1.
HCG is a glycoprotein hormone secreted by the developing placenta during pregnancy. The concentration of HCG in serum is approximately
equal to the concentration in urine. The concentrations of hCG in urine and serum continue to rise during the first trimester of pregnancy to as                                              HCG Concentration (mIU/ml)             0    25    50     100     500
high as 100,000mIU/ml. HCG appears in urine shortly after conception, and continues to increase during the early stages of pregnancy, making                                                            N=                          20    20    20      20      20
it an excellent indicator for the detection of pregnancy.                                                                                                                                             Positive                       0    20    20      20      20
                                                                                                                                                                                                     Negative                       20     0     0       0       0
The membrane of the test device was coated with anti HCG antibodies on the test region and goat anti mouse IgG antibodies on the control              Specificity:
region. During the test, urine specimen is allowed to react with the HCG monoclonal antibody-colloid gold conjugate, which was pre-dried on the       Specificity was determined from cross reaction studies with known amounts of Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH)
test strip. The mixture then moves upward on the membrane chromatographically by capillary action. For a positive specimen, the conjugate             and Thyroid Stimulating Hormone (hTSH). 500mIU/ml hLH, 1000mIU/ml hFSH and 1000mIU/ml hTSH. All gave negative results.
binds to the HCG forming an antibody-antigen complex. This complex is captured by anti HCG antibody immobilized on the test region (T) and
produces a pink color band when HCG concentration is equal to or greater than 25mIU/ml. Absence of this colored band in the test region               Accuracy:
suggests a negative result. To serve as a procedural control, a colored band at the control region(C) will always appear regardless the presence      A study was performed using a total of 66 randomly selected urine specimens. These specimens were assayed with QuickView HCG Test Card
or absence of HCG.                                                                                                                                    and a similar commercial available qualitative visual pregnancy test. The results indicated a complete agreement (36 positive specimens and 30
                                                                                                                                                      negative specimens).
The kits should be stored at temperature 4-30°C in the sealed pouch for the duration of the shelf life.                                               Interference Testing:
                                                                                                                                                      The following substances were added to hCG free and 25mIU/ml hCG spiked urine samples. None of the substances at the concentration tested
PRECAUTION                                                                                                                                            interfered with the assay.
1. For in vitro diagnostic use only.
2. Do not use after expiration date.                                                                                                                                                    Acetaminophen                    20mg/dl
3. Test device should remain sealed until use.
                                                                                                                                                                                        Acetysalicylic acid              20mg/dl
                                                                                                                                                                                        Ascorbic acid                    20mg/dl
1. QuickView HCG cassette with desiccant.                                                                                                                                               Atropine                         20mg/dl
2. Instruction for use                                                                                                                                                                  Caffeine                         20mg/dl
                                                                                                                                                                                        Gentisic acid                    20mg/dl
SPECIMENS COLLECTION                                                                                                                                                                    Glucose                          2.0g/dl
1. The urine specimens must be collected in a clean dry container either plastic or glass without preservatives. No centrifugation or filtration of                                     Hemoglobin                       1.0mg/dl
    urine is required. Specimens collected at any time may be used. However the first morning urine generally contains the highest
    concentration of the hormone.                                                                                                                     REFERENCE
2. If specimens can not be tested within 3 days of collection, they should be stored refrigerated at 2-8 °C.                                          1. Cart, K. J.: J. Clin. Endocrinol.Metab., 1975, 40:537
                                                                                                                                                      2. Brauntein, G. D.: Am. J. Obstet. Gynecol., 1976, 126:678
ASSAY PROCEDURE                                                                                                                                       3. Batzer, F. R.: Fertility & Sterility, 1980, 34:1
1. Bring all materials and specimens to room temperature.                                                                                             4. Engvall, E.: Method in Enzymology, 1980, 70:419
2. Remove the test card from the sealed foil pouch.                                                                                                   5. Wilcox, A. J.: N.England J. Med., 1988, 319:189
3. Label the test card with specimen identity on the “ID ____ “ area of the cassette.                                                                 6. Dawood, M. Y.: Ob. Gyn., 1990, 126:678
4. Place the test card on a flat horizontal surface.
5. Using the transfer pipet to draw up the sample.
6. Hold the transfer pipet in a vertical position over the sample well and dispense 2-3 drops (80-120 l) of sample into the sample well.
7. Read the result at 5 minutes after adding the sample.
 Note: Results after 10 minutes may not be accurate.


                                                                                                                                                        LumiQuick Diagnostics, Inc.                                          Emergo Europe
                                                                                                                                                        2946 Scott Blvd.                                                     Molenstraat 152513 BH The Hague
                                                                                                                                                        Santa Clara, CA 95054 USA                                            The Netherlands
                                                                                                                                                        Tel : (408) 855.0061                                                 Tel: +31(0)70.345.8570
                                                                                                                                                        Fax: (408) 855.0063                                                  Fax: +31(0)70.346.7299

DCR 07-008

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