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3.3.2 Anti HCV Testing (Rapid Method)

The SOP describes the testing procedure for detecting antibodies to Hepatitis C virus in human serum or plasma using a rapid visual test, including the responsibilities, materials, step-by-step procedure, interpretation of results, documentation requirements, and references. The test is a mandatory screening for blood units before transfusion to identify any reactive samples containing HCV antibodies.

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333 views4 pages

3.3.2 Anti HCV Testing (Rapid Method)

The SOP describes the testing procedure for detecting antibodies to Hepatitis C virus in human serum or plasma using a rapid visual test, including the responsibilities, materials, step-by-step procedure, interpretation of results, documentation requirements, and references. The test is a mandatory screening for blood units before transfusion to identify any reactive samples containing HCV antibodies.

Uploaded by

BALAJI
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Model SOP

Standard Operating Procedure

Name of the facility / activity : TTI Testing of Blood unit for Anti HCV
Antibodies by Rapid Method.

SOP no. Effective Date Pages Prepared by Authorised by


3.3.2 27-11-2000 4
Version Review Period Date of Review Reviewed by Number of copies
VI 2 years 01-01-2014 10
LOCATION : TTI Laboratory
SUBJECT : TTI Testing
FUNCTION : Rapid visual test for the qualitative detection of antibodies to Hepatitis C
virus in Human Serum / Plasma.
DISTRIBUTION: Supervisor in charge of TTI testing laboratory
Master File

1. SCOPE & APPLICATION:


HIV is a mandatory test for blood unit screening before it is transfused. This is carried
out on all donor units’ samples.

2. RESPONSIBILITY:
It is the responsibility of technician from TTI Testing lab to carry out the test and
report as required.

3. MATERIAL REQUIRED:
1. Disposable gloves
2. Test Kit ( HCV Tridot Device )
3. Kit insert
4. Blotting paper
5. Paper napkin

Specimen
 Clotted blood / serum sample

Prepared By Approved By
4. PROCEDURE:
Recommendations for the user
(i) The procedural sequence of additions should be strictly adhered to avoid any
discrepant results.
(ii) Bring all the reagents and specimens to room temperature (20-25°C) before
beginning the test, as the immunological sequence of reactions which take place
during different procedural steps shows best performance at room temperature.
DO NOT HEAT OR REPEATEDLY FREEZE/THAW SPECIMEN.
(iii) Place the required number of HCV TRI-DOT test devices at the working area.
(iv) Cut open the pouch and take out the device for performing the test. Write the
sample identification number to be tested on the device for correct correlation
with results.
(v) While adding sample/reagents to the device, be sure to ALLOW EACH SOLUTION
TO SOAK IN BEFORE ADDING THE NEXT SOLUTION. However, drops of each
solution should be added in continuous stream to wet the entire area of
membrane. If the sample does not soak-in within 40-60 seconds, observe the
sample for any suspended particulate matter.
If present, centrifuge the sample at 10,000 r.p.m. for 15 mins. and use a fresh
device to re-run the test. Refer to "SAMPLE / SPECIMEN PROCESSING".
(vi) All solutions and sample should be added to the CENTRE OF MEMBRANE.
(vii) For consistent results ensure FREE FALLING OF DROPS on the membrane holding
the vial/dropper vertically for proper volume.
(viii) Disinfect and DISCARD THE USED DEVICES IMMEDIATELY AFTER READING
RESULT considering it as potentially infectious.

Prepared By Approved By
ASSAY PROCEDURE

Step No. 1
Add 3 drops of Buffer Solution to the centre of the device.
Step No. 2
Hold the dropper vertically downwards and add 1 drop of patient's sample (50 01
serum or plasma) using the sample dropper provided. (use a separate sample dropper
for each specimen to be tested).
Step No. 3
Add 5 drops of Buffer Solution.
Step No. 4
Add 2 drops of Protein-A conjugate.
Step No. 5
Add 5 drop of Buffer Solution.
Step No. 6
Read result immediately and discard the device immediately considering it to be
potentially infectious.

IMPORTANT: It is important to allow each solution to soak in the test device before
adding the next solution.

INTERPRETATION OF RESULTS
NON REACTIVE RESULT
1. Appearance of only one dot at the control region “C” indicates that the sample is
NON-REACTIVE for antibodies to HCV.

REACTIVE RESULT
1. Appearance of two dots, one at the control region “C” & other at the test region
“T1”, indicates that the sample is REACTIVE for antibodies to HCV.
2. Appearance of two dots, one at the control region “C” & other at the test region
“T2” indicates that the sample is REACTIVE for antibodies to HCV.

Prepared By Approved By
3. Appearance of all the three donts, one each at “C” “T1” & “T2” region indicates
that the specimen is REACTIVE for antibodies to HCV.

INVALID RESULT
If no dot appears after the completion of test, either with clear background or with
complete pinkish / purplish background the test indicates ERROR.
This may indicate a procedural error or deterioration of specimen / reagents or
particulate matter in the specimen. The specimen should be retested on a fresh device
(Refer sample / specimen processing).

5. DOCUMENTATION:

In the daily worksheet and rapid testing documentation its important to write;
1. The date on which the test is run.
2. The name of the kit used.
3. Lot No. and expiry date of the kit.
4. Initials of the technologist who performed the test.
5. Initials of the Supervisor who verifies the result.
6. Reactive units are marked in red.

Transfer the results to TTI register and in case of reactive samples immediately issue
instructions or make sure personally to remove the unit along with the components
prepared.

6. REFERENCES:
i. Technical Manual of the American Association of Blood Banks – 15th Edition,
2005.
ii. Kit insert.

7. END OF DOCUMENT

Prepared By Approved By

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