MINISTRY OF HEALTH

SOP Title: : Procedure for Testing Rheumatoid Factor Version 1

SOP No: LGEN. 0027

XXX County.

Facility: _______ _________________

Standard Operating Procedure. SOP No: LGEN.

Version: 1.
Supercedes: N/A
Effective Date:

Title: Procedure for Testing Rheumatoid Factor

NAME. SIGNATURE. DATE.

PREPARED BY.

REVIEWED BY

APPROVAL
AUTHORITY.

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not controlled. Anyone using an uncontrolled copy is responsible for checking that they have the latest revision
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 MINISTRY OF HEALTH
1. Purpose This procedure describes the standard steps for serology testing of autoantibodies in serum for
rheumatoid factor.
2. Scope Used In the Ndaragwa Health Centre laboratory for diagnosis of Arthritis.
3.
4. Responsible Qualified Medical Lab Technologist is responsible for ensuring the effective implementation and
staff maintenance of this procedure.

5. Principle RF latex test is a rapid agglutination procedure, based on modification of the singer method
developed for the direct detection and the semi- quantitation on a slide of rheumatoid factors in
serum.
The assay is performed by testing a suspension of latex particles coated with human gamma
globulin against unknown serums. The presence or absence of a visible agglutination, indicates the
presence or absence of Rheumatoid factor or autoantibodies in the samples tested.

6. Reagents  RF Latex reagent

and Supplies  Pipettes
 Disposable Gloves
 Test cards
7. Equipment  Mechanical rotator
 Lab Stop watch
8. Sample and Refer to sample collection manual (SCM 02)
Container
Type
9. Special Treat all specimens as if potentially infectious and use appropriate personal protective equipments
Safety
precautions
10. Quality  Positive control: Human serum with an activity equivalent to approximately 25IU/ml.
Control  Negative control: Animal serum with an activity < 5IU/ml.
The control are provided with the kit.
Dispense 1 drop of positive control serum and 1 drop of negative control into two circles.
Mix the contents of each circle with a disposable stirrer while spreading over the entire area
enclosed by the ring. Use separate stirrer for each mixer.

11. Detailed  Bring the test reagents and samples to room temperature for around 15 minutes.
procedure  Mix the reagent vial gently. Aspirate several times to obtain a thorough mixing.
 Place 1 drop of the serum under test into one of the circles on the testing card.
 Add 1 drop of RF Latex reagent to each circle next to the sample to be tested.
 Mix the contents of each circle with a disposable stirrer while spreading over the entire
area enclosed by the ring. Use separate stirrer for each mixer.
 Rotate the slides by means of a mechanical rotator for a period of 2 minutes.
 Observe immediately under a suitable light source for any degree of agglutination.

12. Interferences  Use of haemolysed specimen.

and  False negative results may be given by patients in the early or in sub-clinical chronic phases

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 MINISTRY OF HEALTH
Limitation of the disease.
 Positive reaction do occur in conditions other than rheumatoid arthritis such as
mononucleosis, hepatitis, syphilis, and in elderly patients.
15. Result  Record results of investigation on serology book and transfer through LIMS. (Refer to
Reporting procedure for releasing of results .
16. Results  Non –Reactive: Smooth suspension with no visible agglutination as shown by negative
interpretatio control.
n  Reactive: Any degree of agglutination visible macroscopically.
17. Supporting  Sample collection manual SCM 02.
Documents  Procedure for releasing of results SP
18. References  Singer, J. M and Plotz, C. M. Am. J. Med. 21:888 (1956).
 Rheumatoid factor package insert, Abon biopharm co. ltd

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 MINISTRY OF HEALTH

AMMENDMENT SHEET
Proposed by Section Summary of changes Date of amendments

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not controlled. Anyone using an uncontrolled copy is responsible for checking that they have the latest revision
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 MINISTRY OF HEALTH
I have read, understood and agree to follow the procedure as documented:

S/No Name Signature Date

NOTE: This is a CONTROLLED document. Any documents that are not stamped in red “APPROVED” are
not controlled. Anyone using an uncontrolled copy is responsible for checking that they have the latest revision
of the document prior to use.
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