HCG Pregnancy Urine Test by xiaohuicaicai


									                                                                                                                     ASSAY PROCEDURE
                                             HCG Pregnancy Urine Test                                                For the test strip:
                                                                                                                     1. Collect urine specimen with a clean dry container either plastic or class.
      FOR THE QUALITATIVE DETECTION OF HUMAN CHORIONIC GONADOTROPIN                                                  2. Remove the strip from its protective pouch.
                             IN URINE SPECIMENS                                                                      3. Dip the strip in the urine sample for a few seconds. Make sure that the urine level is below “Max” line.
                                                                                                                     4. As soon as solvent front reached the membrane area place the strip on a clean surface.
                           73002           HCG Pregnancy Urine Test Card                                             5. Wait for 5 minutes to read result, even though some positive results may be observed within a minute. Do
                                                                                                                         not try to interpret results after 10 minutes.
                           73006           HCG Pregnancy Urine Test Strip                                            For the test card:
                                                                                                                     1. Bring all materials and specimens to room temperature.
                                   For In Vitro Diagnostic Use Only                                                  2. Remove the test card from the sealed foil pouch.
                                                                                                                     3. Label the test card with specimen identity on the “ID ____ “ area of the cassette.
                                                                                                                     4. Place the test card on a flat horizontal surface.
         TM                                                                                                          5. Using the transfer pipet to draw up the sample.
QuickView HCG Pregnancy Urine Test is a chromatographic immunoassay for the early detection of
human chorionic gonadotropin (HCG) in urine specimens.                                                               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.
INTRODUCTION                                                                                                         7. Read the result at 5 minutes after adding the sample.
HCG is a glycoprotein hormone secreted by the developing placenta during pregnancy. The concentration of              Note: Results after 10 minutes may not be accurate.
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 high as 100,000mIU/ml. HCG appears in           INTERPRETATION OF RESULTS
urine shortly after conception, and continues to increase during the early stages of pregnancy, making it an
excellent indicator for the detection of pregnancy.                                                                                                                                                POSITIVE
PRINCIPLE                                                                                                                                                                                 In addition to the control band

                                                                                                                         TEST STRIP
The membrane of the test device was coated with anti HCG antibodies on the test region and goat anti                                                                                      (C), a distinct colored band
mouse IgG antibodies on the control region. During the test, urine specimen is allowed to react with the HCG                                                                              also appears in the test region
monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip. The mixture then moves                                                                                 (T).
upward on the membrane chromatographically by capillary action. For a positive specimen, the conjugate
binds to the HCG forming an antibody-antigen complex. This complex is captured by anti HCG antibody                                                                                              NEGATIVE
immobilized on the test region (T) and produces a pink color band when HCG concentration is equal to or                                                                                   Only one colored band
greater than 25mIU/ml. Absence of this colored band in the test region suggests a negative result. To serve                                                                               appears on the control region
as a procedural control, a colored band at the control region(C) will always appear regardless the presence                                                                               (C). No colored band in the
or absence of HCG.                                                                                                                                                                        test region (T).
The kits should be stored at temperature 4-30°C in the sealed pouch for the duration of the shelf life.

PRECAUTION                                                                                                                                                                                         INVALID
1. For in vitro diagnostic use only.

                                                                                                                         TEST CARD
2. Do not use after expiration date.                                                                                                                                                      If no bands appear, or a test
3. Test device should remain sealed until use.                                                                                                                                            band appears without a
                                                                                                                                                                                          control band, the test should
REAGENTS AND MATERIALS PROVIDED                                                                                                                                                           be repeated using a new test
1. QuickViewTM HCG Pregnancy Urine Test                                                                                                                                                   device.
2. Instructions for use

1. The urine specimens must be collected in a clean dry container either plastic or glass without
    preservatives. No centrifugation or filtration of urine is required. Specimens collected at any time may be
    used. However the first morning urine generally contains the highest concentration of the hormone.
2. If specimens can not be tested within 3 days of collection, they should be stored refrigerated at 2-8 °C.

      DCR 10-023              73002+73006
      5004-T/S E1R0           04-06-2010                                                                   Page 1 of 2
1. The QuickView HCG Pregnancy Urine Test 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 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 physician after all clinical and laboratory findings have been evaluated.
                                                                                                                              LumiQuick Diagnostics, Inc.   Emergo Europe
PERFORMANCE CHARACTERISTIC                                                                                                    2946 Scott Blvd.              Molenstraat 152513 BH The Hague
Sensitivity:                                                                                                                  Santa Clara, CA 95054 USA     The Netherlands
The analytical sensitivity of QuickView HCG Pregnancy Urine Test has been set at 25mIU/ml. A urine                            Tel : (408) 855.0061          Tel: +31(0)70.345.8570
specimen contains HCG concentrations equal to or greater than 25mIU/ml HCG gives a positive result. The                       Fax: (408) 855.0063           Fax: +31(0)70.346.7299
sensitivity was also evaluated by a panel of urine samples spiked with HCG to the concentrations of 0, 25, 50,                Email: info@lumiquick.com
100, 500mIU/ml. The results are shown in the following table.                                                                 www.lumiquick.com

                               HCG Concentration
                                                           0    25    50    100     500
                                     N=                   20    20    20     20     20
                                   Positive               0     20    20     20     20
                                   Negative               20     0     0      0      0

Specificity was determined from cross reaction studies with known amounts of Luteinizing Hormone (hLH),
Follicle Stimulating Hormone (hFSH) and Thyroid Stimulating Hormone (hTSH). 500mIU/ml hLH,
1000mIU/ml hFSH and 1000mIU/ml hTSH. All gave negative results.

A study was performed using a total of 66 randomly selected urine specimens. These specimens were
assayed with QuickView HCG Pregnancy Urine Test and a similar commercial available qualitative visual
pregnancy test. The results indicated a complete agreement (36 positive specimens and 30 negative

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 interfered with the assay.

                           Acetaminophen            20mg/dl
                           Acetysalicylic acid      20mg/dl
                           Ascorbic acid            20mg/dl
                           Atropine                 20mg/dl
                           Caffeine                 20mg/dl
                           Gentisic acid            20mg/dl
                           Glucose                  2.0g/dl
                           Hemoglobin               1.0mg/dl

1. Cart, K. J.: J. Clin. Endocrinol.Metab., 1975, 40:537
2. Brauntein, G. D.: Am. J. Obstet. Gynecol., 1976, 126:678
3. Batzer, F. R.: Fertility & Sterility, 1980, 34:1
4. Engvall, E.: Method in Enzymology, 1980, 70:419
5. Wilcox, A. J.: N.England J. Med., 1988, 319:189
6. Dawood, M. Y.: Ob. Gyn., 1990, 126:678

       DCR 10-023               73002+73006
       5004-T/S E1R0            04-06-2010                                                                      Page 2 of 2

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