Preparation for the Assay
- Allow all reagents and samples to warm to room temperature (20-30°C) before use. Remove reagents from foam holders. Do not heat reagents in a water bath.
- All reagents are ready for use as supplied. Gently mix the reagents before use; avoid foaming.
- Gently mix the LATEX REAGENT before each use to ensure homogeneity.
Assay protocol - Qualitative
- Using the stirrer pipets, dispense one free-falling drop (0.05 ml) of each serum sample onto a separate circle on the test slide. Use a fresh stirrer pipet for each sample. When using the stirrer pipet, keep it in a vertical position to ensure accurate delivery. Repeat by adding one free-falling drop of REACTIVE or NONREACTIVE CONTROL from the dropper vials supplied. Note the location of each sample by using the numbers located below and to the right of each circle.
- Expel the contents of the LATEX REAGENT dropper and refill. Add one drop of the reagent to each serum specimen and to each control.
- Using the flat end of the stirrer pipets, mix each specimen and control serum with the LATEX REAGENT, in a circular manner, over the entire area in the circles of the slide.
- Gently tilt and rotate the slide for two (2) minutes and observe for agglutination. All test results should be compared to both REACTIVE and NONREACTIVE CONTROLS.
Assay Protocol - Semiquantitative
Prepare serial dilutions of patient serum, in GLYCINE-SALINE SOLUTION, in test tubes as follows:
Testing on additional dilutions should be performed as needed.
Using each dilution as a separate test specimen, apply the samples to the slide as described in step 1 of the “Qualitative Assay Protocol” and proceed with steps 2 through 5 of the “Qualitative Assay Protocol”. Include undiluted sample if not tested previously on that day with the same lot of LATEX REAGENT.
Reactive: Agglutination indicates a CRP concentration of greater than or equal to 6 mg/L in the serum sample.
Nonreactive: Smooth or finely granular suspension with no visible agglutination.