used anti-inflammatory or immunosuppresive drugs, including steroids, unless the disease activity is affected and it covers an exceptionally broad

 

Note

1. In vitro diagnostic reagent for laboratory and professional use only. Not for medicinal use.

2. All the reagents derived from human source have

been tested for HBsAg and anti-HIV antibodies and

are found to be non-reactive.

3. The Reagent contains sodium azide 0.1% as

preservative. Avoid contact with skin and mucosa.

On disposal, flush with large quantities of water.

4. The reagent can be damaged due to microbial

contamination or on exposure to extreme temperatures.

It is recommended that the performance of the reagent

be verified with the positive and negative controls

provided with the kit.

5. Shake the latex reagent well before use to disperse the

latex particles uniformly and improve test readability.

6. Only a clean and dry glass slide must be used. Clean

the slide with distilled water and wipe dry.

7. Accessories provided with the kit only must be used

for optimum results.

Specimen Collection and Preparation

No special preparation of the patient is required prior to

specimen collection by approved techniques.

Only serum should be used for testing. Should a delay

in testing occur, store the sample at 2 to 8°C. Samples can

be stored for up to a week. Do not use hemolyzed serum.

Material Provided with the Kit

Reagent

The RHELAX CRP latex reagent, positive control, negative

control.

Accessories

Glass slide with six reaction circles, sample dispensing

pipettes, mixing sticks, rubber teat.

Additional Material Required

Stopwatch, test tubes, a high intensity direct light source,

isotonic saline.

Test Procedure

Bring reagent and samples to room temperature before

testing.

Serology/Immunology 651

Qualitative Method

1. Pipette one drop of the test specimen (serum) on the

glass slide using a disposable pipette provided with

the kit.

2. Add one drop of RHELAX CRP latex reagent to the drop

of test specimen on the slide. Do not let the dropper

tip touch the liquid on the slide.

3. Using a mixing stick, mix the test specimen and the

RHELAX CRP latex reagent uniformly over the entire

circle.

4. Immediately start a stopwatch. Rock the slide

gently back and forth, observing for agglutination

macroscopically at 2 minutes.

Semiquantitative Method

1. Using isotonic saline, prepare serial dilutions of the

test specimen positive in the qualitative method 1:2,

1:4, 1:8, 1:16 and so on.

2. Pipette each dilution of the test specimen onto

separate reaction circles.

3. Add one drop of RHELAX CRP latex reagent to the drop

of test specimen on the slide. Do not let the dropper

tip touch the liquid on the slide.

4. Using a mixing stick, mix the test specimen and the

latex reagent uniformly over the entire circle.

5. Immediately start a stopwatch. Rock the slide

gently, back and forth, observing for agglutination

macroscopically at 2 minutes.

Interpretation of Test Results Qualitative Method

Agglutination is a positive test result and indicates the

presence of detectable levels of CRP in the test specimen.

No agglutination is a negative test result and indicates the

absence of detectable levels of CRP in the test specimen.

Semiquantitative Method

Agglutination in the highest serum dilution corresponds to

the amount of CRP in mg/dL present in the test specimen.

Concentration of CRP can be calculated as follows:

CRP (mg/dL) = S × D

where S = Sensitivity of the reagent, i.e. 0.6 mg/dL.

D = Highest dilution of serum showing agglutination.

Remarks

1. Markedly lipemic, hemolyzed and contaminated

serum samples could produce non-specific results.

2. Use of plasma rather than serum can lead to false

positive results.

3. The CRP is found to be present after the first trimester

of pregnancy and persists until delivery.

4. The CRP levels increase in women who are on oral

contraceptives.

5. The CRP response is not affected by the commonly

used anti-inflammatory or immunosuppresive

drugs, including steroids, unless the disease activity

is affected and it covers an exceptionally broad

incremental range upto 3000 times.

6. Do not read results beyond indicated testing time

limits.

7. Since CRP production is a non-specific response to

tissue injury, it is recommended that results of the test

should be correlated with clinical findings to arrive at

the final diagnosis.

8. In cases where an increase in CRP levels is suspected,

but the screening test shows a negative result,

semiquantitation should be done to rule out prozone

effect.