FOKUS DIAGNOSTIC

CRP LATEX CHECK TEST

INTENDED USE.
'lhc CRP l,atex Check rest is intended to be used 'Or the
qualitative and semi-quantitative detection ol' CRP in serum.

SUMMARY
CRP usually appears in the sera of' patients in the acute stages or
number or intlanunotory conditions such as most bacterial and
some viral acute rheumatoid tZver with or without
carditis: rheumatoid arthritis and most other collagen diseases:
and in a number of other conditions characterized by
inflammation. CRP is considered to be a sensitive indicator of'
inflanunation. Changes in the sennn level of CRP with time fronl
the same patient can be used as an index of recovery. The use of
the CRP test to measure the effectiveness of therapy is of great
clinical significance in cases such as acute rheumatoid fever.
Since the discovery that rabbits from precipitating antibodies
against CRP l . various immunoprecipitation techniques have been
applied ror its detection. The Fokus CRP Latex Check Test is
based on thc latex-agglutination method introduced by Singer et
al in 19572 . the principle of this test is based on the
( immunological reaction between CRP as an antigen and the
corresponding antibody coated on the surface of biologically inert
latex particles.

MATERIALS SUPPLIED
CRP Latex : Contains polystyrene latex particles coated with
anti-human CRP and suspended in bufter and 0. 1%
sodium azide preservative,
CRP Positive Control: I-luman Serum that contains CRP and 0.
1% sodium azide as preservative.
CRP Negative Control : Human Serum that contains 0.1%
sodium azide as preservative.
Glycine-saline Buffer (20x) Concentrate : To be diluted I with
distilled water. Disposable pipettes and test slides are also
provided.
Additional Item Required : Serological pipettes, 12x75 mm test
tubes and timing device.

STORAGE & STABILITY

When not in use, store reagents and controls at 2 to 8 degree
Celsius. DO NOT FREEZE. Prior to use. allow reagent and
controls to warm up to room temperature. Biological indication
of product instability is evidenced by inappropriate reaction of
the latex reagent with the corresponding positive and negative
control sera.

PRECAUTIONS
This product is For In Vitro Diagnostic Use Only.
The preservative sodium azide may react with metal plumbing
to form explosive metal oxides. In disposal, flush with a large a
volume of water to prevent metal azide build up. Human
control sera were tested for the presence of Hepatitis B Surface
Antigen and HIV-I and HIV-Il antibodies and found to be
negative by FDA approved Inethod. However. all materials
should still be handled as infectious agents.

SPECIMEN COLLECTION
Fresh patient serum specimen should be used in the testing. If
testing cannot be performed aner collection, specimen should
be kept refrigerated. If testing is to be prolonged in excess of 24
hours. serum should be frozen. Bacterial contamination may
 cause protein denaturation. Strongly lipemie sera and/or
bacterial contmnination may cause positive agglutination.

cRP
PROCEDURES The presence of RF (usually >20 IU/ml) may lead to false
A. Method I (Qualitative) Bring reagent. controls and positive results.
serum samples to rooln temperature.
Shake. The CRP reagent gently before use.
Deliver one drop of reagent to the test circle, EXPECTED VALUES
Using the disposable pipettes, add one drop of Normal adult levels of CRP are reported to be less than 12 mg/L.
the undiluted patient serum onto the same circle trace levels of CRP had been reported in the sera of apparently
and mix both together with the paddle end or the healthy adulte and normal children! The CRP level can increase
pipette. significantly (>l() 161d) above the normal values with the onset
3. Positive and negative controls should be run with ol' a substantial inllanltnatory stimulus.
each series of test serums in the same way as in
Step 2. SPECIFIC PERFORMANCE CHARACTERISTICS It Illust be
4. Rotate slide back and forth for 2 minutes and stressed that the latex agglutination technique is more sensitive
read result under an indirect oblique light source. than precipitation in capillary lubes or in agar gel methods. thus
giving positive results at lower CRP levels. The CRP levels in
B. Method Il (Semi-Quantitative) set up at least 5 test patients with strongly positive CRP reactions had been detected
tubes and label 1 :2, 1 :4. 1:8, 1 :16, 1 :32, etc as high as 330 ing/L 5 while the CRP content of normal serum is
less than • 1 2 mg/L1.
2. Use diluted Glycine-Saline to serially dilute
sample to be titered according to standard The CRP latex Check •est was compared to another commercial
laboratory practice. CRP Latex •re •t and CRP Neophelometry Test, both produced by
3. Repeat all steps as in Qualitative method using Behrin . A total of 42 specimens were evaluated with the
these new samples. following results. The titres of the specimens were determinéd by
all three methods.
)RESULTS
Expected Result , CRP Test Behrin CRP Test
Positive reaction is indicated by agglutination. Since negative
results may be caused by antigen excess, the test should be Positive 14\14 12
repeated using a diluted serum sample in case prozone effect is Negative 27+\28 27\28
suspected. For the Semi-Quantitative method, multiplication of
the dilution factor with 6 mg/L will yield the approximate level The two specirnens were found to countain 7.8 and 6.5 mg/L
of CRP in the serum sample. CRP using the Behring nephelometry method.
The one negative specimen was found to contain 6.6 mg/L of
DILUTION CONCENTRATION (mg/L) CRP by the Behring nephelometry method.
1:1 (neat specimen, no dilution required) 6
12 BIBLIOGRAPHY
24 MacCleod. C.M. & O.T.Avery: J. Exper. Med. n.
48 191, 1950.
2. Singer,
OUALITY CONTROL PROCEDURE J.M... & c.M.
Positive and Negative Controls are supplied to permit users to Plotz: Am. J.
become familiar with the expected positive and negative results. Med.. 21. 888. 1956.
The positive control will produce, usually within I minute, 3. ScherfTath, F.: M. Perez-Miranda & H. Goetz: Blut
agglutination against a smooth background. The negative control 20. 296, 1970.
will produce no agglutination after the required two minute 4. Saxtad, J.. L.A. Nilsson & L.A Hanson: Acta
rotation. The negative result shold be used as a basis for Paediat. Scand. 59,25, 1970.
comparison. The relative degree of the smoothness of the CRP 5. Wood. H.F. & M.McCarty: J. Clin. Invest. 30,616,
reagent itself should be considered and incorporated in reading 1951.
the results. If the indicated results, using the positive and negative
controls, deviate from the expected results, the Fokus CRP
Antigen Check Test should not be used.

LIMITATION OF THE PROCEDURE

The strength of the agglutination reaction is not indicative of the 1 . Nißson, L.A., Acta Path. Microbiol.
CRP concentration. Weak reactions may occur with slightly Scand. 73, 129, 1968.
elevated or markedly elevated concentrations. A prozone
phenomena (antigen excess) may cause false negatives. It is
advisable, therefore, to check all negative sera by retesting at a
1:10 dilution. Reaction times longer than specified may prodüce
apparent false reactions. Only serum should be used in this test.
Specimens containing Rheumatoid Factor (RF) should not be
used. The presence of RF can be confirmed by using
commercially available RF Latex Check Test (e.g. Latex Test). N tCki
2