╨╧рб▒с>■  <>■   ;                                                                                                                                                                                                                                                                                                                                                                                                                                                ье┴7 Ё┐bjbjUU )27|7|ї      lFFFF║║║╬lll8д ░T╬T2яяяў∙∙∙∙∙∙Ж жn∙║яыяяя∙GFF█GGGяшFR║ўGяўGbGйrTШ"║s АMкu$ч├╬Ю l╫pWsД$0Te G sG╬╬FFFF┘ Catalogue Number Product Description CRP/010 Test Kit 50 CRP/012 Test Kit 100 INTRODUCTION CRP is a serum constituent originally defined by its ability to precipitate Pneumococcus C polysaccharide(. Characteristically, CRP appears in the serum of individuals in response to various inflammatory conditions and tissue necrosis and disappears as the causative conditions subside. It is routinely found in cases of bacterial infection(, active rheumatic fever( and many malignant diseases and is often seen in association with cases of rheumatoid arthritis, viral infections and tuberculosis. CRP has also been detected in patients following blood transfusions and surgical operations( as well as in patients with burns, pemphigus vulgaris and other bullaous lesions. KIT PRESENTATION Latex reagent sufficient for 50/100 slide tests (Yellow label). The latex reagent should be well shaken to ensure homogeneity. Positive Control (Red label). This serum is human positive CRP serum. This reagent is ready for use and will give positive results when tested with the Plasmatec CRP latex test. Negative Control (Blue label). This control is a negative CRP control serum. This reagent is ready for use and will give a negative result when tested with the Plasmatec CRP latex reagent. 10x Conc. Glycine Diluent Buffer (Green label). Add one part to nine parts distilled water before use. On dilution the diluent has a pH between 8.0 and 8.2. Pipette/ Stirrers/ Reusable agglutination slide. ADDITIONAL REQUIREMENTS Small glass or plastic test tubes / Serological pipettes STORAGE The reagents must be stored upright, well closed at 2-8║ C. SAMPLE PREPARATION Use fresh serum obtained by centrifugation of clotted blood. The sample may be stored at 2-8( C for 48 hours before performing the test. For longer periods of time the serum must be frozen. Haematic, lipaemic or contaminated serum must be discarded. TEST REAGENTS All the reagents must be allowed to reach room temperature before use. Do not freeze any of the reagents. QUALITATIVE METHOD Allow each component to reach room temperature. Gently shake the latex reagent to disperse the particles. Place a drop of undiluted serum onto the circle of the test slide using the disposable pipettes provided. Add one drop of the latex reagent next to the drop of serum. Using the other end of the pipette (broad end) spread the reagent and serum sample over the entire area of the test circle. Gently tilt the test slide backwards and forwards approximately once every two seconds for two minutes. Positive and negative controls should be included at regular intervals. Both are ready for use and do not require further dilution. At the end of the test rinse the test slide with distilled water and dry. Normal laboratory precautions should be maintained while handling patients samples. RESULTS Presence of agglutination indicates a level of CRP in the sample equal or > 6mg/l. The lack of agglutination indicates a CRP level < 6mg/l in the sample. SEMI-QUANTITATIVE DETERMINATION The semi-quantitative test can be performed in the same way as the quantitative test using dilutions of the serum in saline, phosphate buffered saline or glycine saline as follows:- Dilutions1/21/41/81/16Sample serum100( l---Saline100( l100( l100( l100( l (100( l ( 100( l (  100( lVolume of sample50( l50( l50( l50( l6xN║. Of dilution6x26x46x86x16Mg/I.U./ml12244896 Normal Levels :- Adults < 6mg/l RESULTS The titre is expressed as the reciprocal of the highest dilution showing macroscopic agglutination: e.g. if this occurs in dilution 3, the titre is 48 INTERPRETATION OF RESULTS The elevation of CRP levels above normal indicates tissue damage, inflammation, or both with greater reliability(. The CRP latex has been standardised to detect serum CRP levels at or above 6(g/ml, which is considered the lowest concentration of clinical significance. The regular monitoring of CRP levels is often used as a means of assessing disease activity and of guiding therapy. CRP determination is considered to be a greater practical significance than any other indicator of inflammatory disease. The erythrocyte sedimentation rate (ESR) for example, may become elevated as a result of non-inflammatory conditions. In these circumstances inflammatory disease may be excluded if CRP is absent. SAFETY PRECAUTIONS The reagents and controls contain less than 0.1% sodium azide as a preservative. Avoid ingestion and contact with skin or mucus membrane. Each donor used in the preparation of this kit was tested by a FDA approved method for the presence of HIV antibodies and Hepatitis B antigen and found to be negative. However normal laboratory precautions should be maintained while handling test reagents REFERENCES Tillet, W.S., and Francis, T., J. Exp. Med. 52:561 (1930) Dawson, S.E., Arch. Dis. Child 32:454 (1957) Anderson,H.C., and McCarthy, M., Am. J. Med. 8:445 (1950) Crockson, R.A., at al., Clin. Chrim. Acta 14: 435 (1966) Hayashi, H., and Loggrippo, G.A., H. Ford Hosp. Med. 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