gabControl CrP

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					gabControl® – CrP (10-30)
Test for semiquantitative detection of CrP.
Product ID: M07CR03

Rapid diagnostic test for semiquantitative detection of CrP in whole blood, serum or plasma
For professional in vitro diagnostic use only.
INTENDED USE                                                                                     • The test should be carried out immediately after taking the sample. Do not store
The gabControl® CrP Test is a rapid chromatographic immunoassay for the                            samples at room temperature for any length of time. Do not freeze whole blood. Whole
semiquantitative detection of CrP in whole blood, serum or plasma for the verification and         blood taken from the fingertip should be tested immediately.
observation of inflammations caused by e.g. bacterial infections or arteriosclerosis. The        • If the samples are to be sent out then they must be packaged in accordance with local
sensitivity is 10 mg/l with a 30 mg/l reference line.                                              regulations governing the transport of pathogenic agents.
SUMMARY
                                                                                                 PACKAGE CONTENTS
CrP is an acute phase protein whose concentration in the blood rises in case of both
                                                                                                    gabControl® CrP Test
infectious and non-infectious diseases, but especially in case of bacterial infections. CrP is
                                                                                                    Disposable droppers
also present in healthy individuals, with 10 mg/l regarded as the normal level for adults. CrP
                                                                                                    Micropipette (10 µl)
is a non-specific marker of inflammation which is also used e.g. for the evaluation of
                                                                                                    Buffer
inflammatory diseases. If increased CrP levels are observed in otherwise healthy individuals
                                                                                                    Mixing tube
free of inflammation, then this constitutes a risk factor for arteriosclerosis. Increased CrP
                                                                                                    Package insert
levels must always also be diagnosed independently of clinical symptoms. CrP has become
the most important non-specific parameter in the diagnosis of inflammation because it still
increases before a non-suspicious leukocyte count or fever and also returns to normal very
                                                                                                 MATERIALS REQUIRED BUT
quickly after the inflammation has cleared up. CrP can be used to track the progression of
                                                                                                 NOT SUPPLIED
an illness. Viral infections are accompanied by only marginal increase in CrP levels.
                                                                                                      Sample collecting container
The CrP concentration in the blood can give an indication of the severity of an illness:
                                                                                                      (for whole blood from arm vein)
< 10 mg / l:          Normal level for adults
                                                                                                      Lancet (only for whole blood sample from fingertip)
10 - 50 mg / l:       Slight or local inflammation
                                                                                                      Centrifuge
> 50 mg / l:          Severe inflammation
                                                                                                      Laboratory pipette with 3.5 µl tip
> 100 mg / l:         Serious illness, sepsis, bacterial meningitis, etc.
                                                                                                      (or appropriate capillary tube)
The gabControl® CrP Test detects CrP in whole blood, serum or plasma and gives a                      Timer
semiquantitative and selective result within minutes. The sensitivity is 10 mg/l with a 30
mg/l reference line.                                                                             TEST PROCEDURE
PRINCIPLE                                                                                        1     Before starting test procedure allow gabControl® CrP Test card, specimen, buffer
The gabControl® CrP Test is a semiquantitative membrane-based immunoassay for the                      and/or controls to reach room temperature (15-30°C).
                                                                                                 2     Remove the gabControl® CrP Test from the foil pouch and use as soon as
detection of CrP in whole blood, serum or plasma. The membrane is coated with CrP
antibodies in the test line area. During the test the sample reacts with the particles coated          possible afterwards. Lay the test materials on a clean and level surface.
with the anti-CrP antibodies. The mixture migrates chromatographically along the                 3     Put 10-12 drops of the buffer solution in the mixing tube.
membrane by capillary action and reacts with the CrP antibodies held on the membrane                   Hold the tube vertically as you do so to prevent trapped air.
and generates a coloured line.
If the CrP concentrations in the sample are below the cut-off point then no coloured line
will appear in the test area: this indicates a negative result (<10 mg/l). If a test line (T)
appears which is fainter than the reference line (R), this indicates that the CrP
concentration in the sample is between 10-30 mg/l. A test line (T) with identical or near-
identical intensity to the reference line (R) indicates that the CrP concentration in the
sample is around 30 mg/l. A test line (T) which is brighter than the reference line (R)
indicates that the CrP concentration in the sample is above 30 mg/l. A coloured line will
always appear in the control line area (C) where it acts as a procedural control indicating
that the correct size of sample has been taken and verifying full penetration of the
membrane.                                                                                        4A      Whole blood samples
                                                                                                         Fill the micropipette (provided with the kit) with approx. 10 µl of the
PRECAUTIONS                                                                                              whole blood sample from the vein or the whole blood sample from
• For professional in vitro diagnostic use only.                                                         the fingertip and transfer it to the mixing tube filled with buffer
• Do not use beyond the expiry date.                                                                     solution.
• Keep the test cassette in its sealed pouch until use.
• Do not eat, drink or smoke when handling samples and tests.
• Do not use the test if the pouch is damaged.
• All samples and controls must be treated as infectious material. Observe any
  precautionary measures which have been put in place and follow the standard
  procedures for correct disposal of specimens and control samples.
• Wear appropriate protective clothing when examining the samples (laboratory coat,
  disposable gloves and safety glasses).
• Dispose of the used test in accordance with local requirements.
• Humidity and temperature may adversely affect the results.
STORAGE AND SHELF LIFE
Store as packaged in the sealed pouch either at room temperature or refrigerated
(2-30°C). The test can be used until the expiry date printed on the sealed pouch and
should be kept in the sealed pouch until used. DO NOT FREEZE. Do not use after the
expiry date.
                                                                                                 4B      Serum or plasma samples
SPECIMEN COLLECTION AND PREPARATION                                                                      Fill the laboratory pipette or capillary tube (not provided with the
• The gabControl® CrP Test can be carried out with whole blood (from the arm vein or                     kit) with approx. 3.5 µl of serum or plasma and transfer it to the
  fingertip), serum or plasma.                                                                           mixing tube filled with buffer solution.
• Extraction of whole blood from the vein: Collect blood samples with anticoagulants
  (Na-heparin) using standard laboratory procedures.
• Extraction of whole blood from the fingertip:
  • Clean the patient's hand with soap and warm water or with an alcohol-impregnated
      wipe. Allow to dry.
  • Massage the hand towards the tip of the middle finger or ring finger without touching
      the prepared needle entry point.
  • Puncture the skin with a sterile lancet. Wipe away the first drop of blood.
  • Gently rub the palm of the hand from the wrist towards the finger to form a drop of
      blood at the needle entry point.
  • Collect the blood with the end of the micropipette supplied until about 10 µl has
      been collected (to black line). Avoid trapping air.
  • Put a dispensing bulb on the top end of the capillary tube (neither item included in
      package contents) which, when squeezed, will deposit the blood sample on the test
      device sample well.
• Serum or plasma should be separated from the blood as soon as possible to prevent
  haemolysis. Use clear, non-haemolysed samples only.                                            5       Mix buffered sample in tube thoroughly.
gabControl® – CrP (10-30)
Test for semiquantitative detection of CrP.
Product ID: M07CR03

6       Add 3 drops of specimen mixture to                               QUALITY CONTROL
        the specimen well.                                               The test incorporates a procedural check. The appearance of coloured lines in the
                                                                         control area (C) and the reference area (R) is considered as a built-in procedural check.
                                                                         It confirms the presence of sufficient sample, complete membrane wicking and correct
                                                                         execution of the test.
                                                                         Control standards are not supplied with this test kit. It is advisable to check positive and
                                                                         negative controls using standard laboratory practice in order to confirm the accuracy of
                                                                         the test procedure and the test results.

                                                                         LIMITATIONS
                                                                         1. The gabControl® CrP Test is for professional in vitro diagnostic use only. The test
                                                                            is designed exclusively for semiquantitative detection of CrP in whole blood, serum
                                                                            or plasma.
7       Wait for the red line(s) to appear. The result should be         2. The gabControl® CrP Test only indicates the semiquantitative concentration of CrP
        interpreted after 5 minutes. Result must be interpreted within      in the sample and should not be the only factor taken into consideration when
        7 minutes.                                                          diagnosing inflammations or arteriosclerosis.
                                                                         3. As with all diagnostic tests, all the results available to the physician must be
                                                                            interpreted in conjunction with other clinical information.
INTERPRETING THE RESULTS                                                 4. Should the test result be negative but the clinical symptoms persist, it is advisable to
POSITIVE: Three distinct coloured                                           do further tests or adopt other clinical methods. A negative result does not ever rule
lines appear.                                                               out the potential presence of a bacterial inflammation at some time.
A: The test line (T) is fainter than the                                 5. Viral inflammations cannot be detected with this test.
reference line (R), indicating that the                                  6. Extremely high CrP concentrations can have a "prozone effect" which can decrease
CRP concentration in the sample is                                          the intensity of the T line. This effect can be observed with CrP concentrations >
between 10-30 mg/l.                                                         1,000 mg/l.
                                                                         7. Samples with abnormally high rheumatoid factors can affect the result and bring
                                                                            about non-specific positive results.
B: The test line (T) is close to the
reference line (R) in intensity,                                         Interfering substances
indicating that the CRP concentration                                    Samples were mixed with the following potentially interfering substances:
in the sample is around 30 mg/l.                                         Acetaminophen                    20 mg/dl     Glucose                         2 g/dl
                                                                         Acetylsalicylic acid             20 mg/dl     Haemoglobin                 500 mg/dl
                                                                         Ascorbic acid                    20 mg/dl     Ketone                       40 mg/dl
                                                                         Atropine                         20 mg/dl     Mestranol                     3 mg/dl
                                                                         Bilirubin                        60 mg/dl     Nitrite                      20 mg/dl
                                                                         Caffeine                         20 mg/dl     Tetracyclines                20 mg/dl
C: The test line (T) is brighter than                                    Creatinine                       20 mg/dl     Na-heparin                    3 mg/dl
the reference line (R), indicating that                                  Gentisic acid                    20 mg/dl     Li-heparin                    3 mg/dl
the CRP concentration in the sample                                      None of the substances in the concentrations tested interfered with the gabControl®
is over 30 mg/l.                                                         CrP Test.

                                                                         LITERATURE
                                                                         1. Caswell M. Effect of patient age on tests of the acute-phase response. Arch Pathol
                                                                            Lab Med 1993;117:906–909.
NEGATIVE: Two coloured lines                                             2. Anderson R , Hugander A , Ghazi S , Ravan H , Offenbartl S, Nystron P et al.
appear in the control and reference                                         Diagnostic value of disease history, clinical presentation and inflammatory
areas. No distinct coloured line                                            parameters of appendicitis. World J Surg 1999;23(2):133-40.
appears in the test area (T).                                                                                                              Rev.: 25/04/2008 (TL)
The concentration in the sample is
below 10 mg/l.                                                           MEANING OF SYMBOLS


INVALID: No control line (C) and/or
reference line (R).
Insufficient amount of specimen or
incorrect procedure are the most
likely reasons why the control and
reference lines fail to appear.
Check the procedural stages and
carry out the test with a new test. If
the problem persists, discontinue
using the test pack immediately and
contact your supplier.

				
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