(SOP)STANDARD OPERATING PROCEDURE: RAPID PLASMA REAGIN TEST

                                        BLOOD CENTRE NAME

SOP Number	Effective date	Pages	Author	Authorised by
Version	Review Period	No. of copies	Reviewed by	Date

LOCATION   TTI Testing	SUBJECT Rapid Plasma Reagin test
FUNCTION     -VDRL Test	DISTRIBUTION – Supervisor in charge of TTI Testing Laboratory – Master File

1. SCOPE & APPLICATION

The samples from donors are tested for Transfusion Transmitted Diseases. These tests are mandatory.

2. RESPONSIBILITY

It is the responsibility of technician on sample receiving desk to ensure correct samples received from patients. The responsibility of carrying out the test is of the technician in the TTI Testing Laboratory.

3. REFERENCE

Kit Package insert.

4. PROCEDURE

4.1       Principle:

• Venedex is an antigenic cardiolipin based emulsion for detecting syphilis regains (antibodies) in serum, plasma and spinal fluid.

• Venedex emulsion contains cardiolipin, lecithin and cholesterol as its active components which produces a flocculation reaction with serum or plasma that contain syphilis antibodies(regains).

Reagent Storage:

Reagent is stable at 2-8⁰C. Bring to room temperature before use and gently stir the reagent

      Method:

1. Samples do not need in activation.

• Centrifuge the samples to be tested.

• Take a VDRL slide i.e. slide with twelve concave depressions, thoroughly clean and dry it.

• Arrange samples to be tested in a tube rack and label them serially.

• Using a pipette transfer 0.05ml of serum or plasma of the 1^st sample on the concave depression.
• Discard the tip.

• Attack a new tip to the pipette and deliver 0.05ml of the 2^nd  sample.

• Repeat this step for all the samples.

• Note the position of the samples added.

1. Lastly add the negative and positive controls.

1. Mix the Venedex reagent and add one drop to all the test samples, negative and positive controls contained in a VDRL slide.
2. Rotate the VDRL slide at 180 rpm for four minutes.

1. Examine macroscopically and microscopically for flocculation.

1. Repeat reactive and doubtful results again along with controls.

6. INTERPRETATION

Test results are reported by comparing it with positive control and negative control results.

• REACTIVE: Presence of flocculation indicates the presence of anti-lipoidalantibodies in test samples. Strength of flocculation depends upon the degree of positivity of the test samples.

• NON-REACTIVE: Absence of flocculation indicates the absence of antilipiodalantibodies in test samples. Strength of flocculation depends upon the degree of positivity of the test samples.

• DOCUMENTATION

The details of the VDRL test done each day is written in the VDRL register. The following entries are made:

• The date on which the test is run.

• The name of the kit used.

• Lot number and expiry date of the kit.

• Initials of the technologist who performed it.

The units tested are recorded in the register as per the arrangement in the test tube rack. The controls used are also recorded.

“R” (Reactive) is written across the reactive unit in red.

“NR” (Non Reactive) is written across the non-reactive units.

Results of controls in use are also recorded.

I.P.C.:Reactive (Internal Kit Positive Control).

I.N.C.:Non Reactive (Internal Kit Negative Control).

E.P.C.1:Reactive (Lab. External Strong Positive Control).

E.P.C. 2:Reactive(Lab. External Weak Positive Control).

E.N.C.Non Reactive (Lab. External Negative Control).

The record is then transferred to donor grouping register.

8. END OF DOCUMENT