BIOCARDTM HCG by niusheng11


									                                               BIOCARDTM HCG                                                           12.08.2008

    BIOCARDTM HCG is an immunochromatographic test for the rapid detection of hCG in urine or
    serum samples.


BIOCARDTM HCG is a disposable                  hormone or if its level is very low, the     EXPECTED VALUES
immunochromatographic testing device           dyed hCG-antibody complex will not be
for the qualitative assay of human             formed and the dyed antibody will freely     Urine and serum samples from healthy
chorionic gonadotropin (hCG) in urine          pass the stationary anti-hCG antibody        men and non-pregnant women should
and serum for laboratory and                   and will later be captured by the control    not contain detectable levels of hCG.
professional use.                              indicator zone, leading to the formation     Concentration of 25 mIU/ml, the cut-off
                                               of a one coloured line, the control line.    value of the BIOCARDTM HCG test is
INTRODUCTION                                   The sensitivity of the BIOCARDTM             normally reached in about 10 days after
                                               HCG test has been adjusted so that it        conception. By the end of the first
Human chorionic gonadotropin (hCG) is          will detect hCG at a level equal or higher   trimester of pregnancy levels of up to
a glycoprotein hormone produced by the         than 25 mIU/ml (referenced to the World      200.000 mIU/ml can be reached.
placenta. In normal pregnancy hCG              Health Organisation Third International
appears in serum and urine soon after          Standard). This level is normally reached    CONTROLS
conception. The concentration of the           in approx. 10 days after conception.
hormone increases rapidly and therefore                                                     Good laboratory practice recommends
it serves well as an indicator of              MATERIALS PROVIDED                           routine use of controls to ensure proper
pregnancy. The level of hCG in urin and                                                     performance of the test. Performance of
serum is about 100 mIU/ml at the time          BIOCARDTM HCG 3-008-600               BIOCARDTM HCG can be checked by
of the first missed menstrual period. The      20 disposable BIOCARDTM HCG tests            means of known positive and known
highest values (100.000 - 200.000              single-packed in foil pouches                negative urinary or serum samples. A
mIU/ml) can be demonstrated towards            20 disposable pipettes                       positive sample shall give a positive
the end of the first trimester.                Instructions for use                         reaction when tested according to the
                                                                                            instructions of use and a negative sample
PRINCIPLE OF THE TEST                          Materials needed but not provided with       shall give a negative result.
                                               the kit: sample collection cup and timer.    Note: Standards and controls which
The BIOCARDTM HCG test is based on                                                          contain fragmented hCG may give
immunochromatography. The test device          STABILITY AND STORAGE                        discrepant results when tested by
includes a chromatographic membrane                                                         different hCG-assay methods.
with two stationary antibody zones,            BIOCARDTM HCG tests shall be stored
rehydratable mobile dyed antibody              at +2…+30 °C in original unopened            TEST PROCEDURE AND
against hCG and a filter.                      pouches. Each test unit contains a drying    INTERPRETATION OF THE
Testing is performed by adding a few           agent. Test units shall be used without      RESULTS
drops of urinary sample into the sample        delay after opening the pouch. The shelf
window of the BIOCARDTM HCG                    life of BIOCARDTM HCG is two years           A. Bring the specimens to room
testing device. The sample flows through       from the date of manufacture. The expiry     temperature.
a filter after which it is absorbed into the   date is indicated on the package.            B. Remove the test device from the
membrane where it comes into contact                                                        pouch (one device for each specimen)
with the different reagent zones. In the       COLLECTION OF SAMPLES AND                    and place the device on the bench. Do
first zone it rehydrates the dyed antibody     STORAGE                                      not touch the device during the 5-minute
against hCG. The hormone in the                                                             testing time.
specimen reacts with the dyed antibody         The concentration of hCG is highest in       C. Hold the pipette in a vertical position
thus forming a dyed hCG-antibody               the first urine of the morning. Therefore    and pipette dropwise 3 free-falling drops
complex. This complex migrates further         in the very beginning of pregnancy it is     (totally approx. 100 microliters) of
in the membrane towards the stationary         recommended to use such a specimen.          sample in the sample window of the
anti - hCG zone. The stationary antibody       However, if this is not possible any other   device. Use the disposable pipette
captures the dyed hCG-antibody                 sample can be used.                          provided with the kit (one pipette for
complex under formation of an                  Serum samples should be taken                each specimen).
intensively coloured line, the test line.      aseptically avoiding hemolysis. Plasma
                                               samples cannot be used.                           SAMPLE TEST         CONTROL
The excess of the dyed antibody not
captured by the test line will be captured     Samples can be stored at room
                                               temperature (+15...+30 °C) for up to 8
by the second stationary antibody, which
reacts with the immunoglobulin part of
the dyed antibody, leading to the              hours and refrigerated (+2...+8 °C) for
formation of a second intensively              up to two days. At (>-10 °C) the samples
coloured line, the control line, indicating    can be stored for up to 4 months.            D. Read the result after about 5 minutes
proper performance of the test. If the                                                      after having applied the specimen.
specimen does not include hCG-
The test result is positive when two                                     BIOCARDTM HCG                                      TM
                                                                                              Do not reuse BIOCARD            HCG test
coloured lines are seen in the result                                          +    -         units. Do not use expired tests or tests
window, that is, the concentration of          Other commercial          +   48    0          from a lot not showing proper
hCG in the sample matches or is higher         kit                       -    0   72          performance when tested with the
than 25 mIU/ml.                                                                               controls. Do not use a test unit from a
                                      3-008-00G is equivalent to 3-           pouch which has been damaged during
                                               008-600 when tested with urine samples.        storage.
                                                                                              When assessing whether a woman is
                                               Sensitivity                                    pregnant or not, instead of relying solely
                                               The detection limit of BIOCARDTM               on the test result given by the
              POSITIVE                         HCG has been determined according to           BIOCARDTM HCG it is necessary to
                                               World Health Organization 3rd.                 take into consideration all the patient
If a only one definite red line, the control   International Stardard 1986, Chorionic         information which may influence
line is formed, the test result is negative,   Gonadotropin 75/537.                           pregnancy.
that is, the hCG-concentration in the
                                                                                              At the very beginning of pregnancy the
sample is lower than 25 mIU/ml.                Specificity                                    concentration of hCG is below 25
                                               hCG-negative urine specimens with              mIU/ml and BIOCARDTM HCG will
                                               added glycoprotein hormones (LH 400            give a negative result. In case a urinary
                                               mIU/ml and FSH (600 mIU/ml) gave               sample is too dilute, the amount of hCG
                                               negative results when tested with              may not be representative and this may
                                               BIOCARD HCG.                                   lead to a negative test result at an early
                                                                                              stage of pregnancy.
             NEGATIVE                          Interfering substances
                                               When the following substances were             Lower content than normally can be
Note: you can read a positive result as        added to a negative and positive               explained for example with extra uterine
soon as the two red lines are distinctly       specimen (60 mIU/ml) they did not              pregnancy. Apart from pregnancy, an
visible. In most cases a positive result is    affect the test result:                        elevated level of hCG and a positive test
interpretable in one to two minutes.                                                          result can be caused by trophoplastic and
If the test line is extremely faint, which     Compound:                                      non-trophoplastic neoplasms, which
may indicate that the concentration of                                Concentration (mg/dl)   should to be taken into consideration
hCG is just below the cut-off level of 25      Asetamnophen           20
                                               Asetoacetic acid       1500
                                                                                              when       interpreting    a     positive
mIU/ml, repeat the testing with a new          Asetone                1250                    BIOCARDTM HCG test result.
sample taken 2 days later.                     Asetylsalisylic acid   20
Read the test result within 15 min after       Albumin                1400                    Manufacturer:
having applied the sample. A positive          Ampicillin             40
                                               Askorbic acid          40                      Ani Biotech Oy, Tiilitie 3,
result will remain unchanged for several       Biotin                 30 µg/dl                01720 Vantaa, FINLAND
hours but after a long reaction time a         Caffeine               40            
faint test line may appear although the        Codeine                5 µg/ml                 e-mail:
                                               Cortisol               150 ng/ml
concentration of hCG is below the cut-         Creatinine             200                     tel. +358-20 155 7510
off level.                                     DHEAS                  10                      fax. +358-20 155 7511
                                               Estrone                25 ng/ml
INVALID TEST RESULT                            Estradiol              25 ng/ml
                                               Estriol                25 ng/ml
                                               Ethanol                4000
If no coloured control line is formed the      Hemoglobin             30 g/l
test device is damaged and so the test         Hydroxybutyric acid    100
result shall be rejected. In such a case       Glucose                20 g/l
                                               Oxalic acid            5000
repeat the test with a new test unit.          Progesterone           50 ng/ml
                                               Phenobarbital          10 µg/ml
PERFORMANCE                                    Salisylic acid         1500
                                               Secobarbital           10 µg/ml
CHARACTERISTICS                                Sodium carbonate       1500
                                               Sodium chloride        5000
Accuracy                                       Tetracycline           40
                                               Urea                   3500
                                               Uric acid              10
212 urine samples were analyzed
parallelly by BIOCARDTM HCG
( 3-008-00G) and the earlier            PRECAUTIONS AND
documented BIOCARDTM HCG (              LIMITATIONS
3-008-000). The results were as follows:
                                               If instructions for use are not carefully
                  BIOCARDTM HCG                followed, false results may appear.
         3-008-00G            BIOCARDTM HCG tests shall be used
                         +       -             only for in vitro detection of hCG in
BIOCARDTM HCG + 81               0             urine and serum samples according to 3-008-000   - 0       131              the instructions of use.
                                               General laboratory procedures and
When 120 urine specimens were                  precautions shall be followed in handling
evaluated using the BIOCARDTM HCG              and disposal of samples and used testing
test and another commercially available        material.
kit, the results were as follows:

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