COMB AIDS
RS
PURPOSE:- TO DESCRIBE STEP WISE INSTRUCTIONS OF
COMB AIDS IN THE LABORATORY.
SCOPE:- TO DEFINE ALL THE DETAILED INSTRUCTIONS OF
COMBAIDS.
RESPONSIBILITY:- IT IS THE RESPONSIBILITY OF THE LAB
TECHNICIAN TO PREPARE THE AND
GET IT APPROVED FROM INCHARGE.
INTENDED USE:-DOT IMMUNOASSAY INTENTED FOR THE
QUALITATIVE DETECTION OF IgG / Igm ANTIBODIES TO THE
HIV TYPE 1 AND 2 IN HUMAN WHOLE BLOOD , SERUM AND
PLASMA.
PRINCIPLE- THE IMOBILISED ANTIGEN- ANTIBODY COMPLEX IS
VISUALISED BY MEANS OF COLOUR PRODUCING REACTION.
SAMPLE WHOLE BLOOD, SERUM AND PLASMA CAN BE USED.
REAGENTS REAGENT 1- WASHING BUFFER
REAGENT 2- COLLIDAL GOLD SIGNAL
REAGENT
REAGENT3- SAMPLE DILUENT
REAGENT4- NEGATIVE CONTROL
REAGENT5- POSITIVE CONTROL
REAGENT6- ANTIGEN & CONTROL REAGENT
COATED COMBS.
ACCESSORIES
1. WASH RESERVOIR
2. 8 MICROWELL STRIPS
3. FOUR-ROW FRAME
4. DISPOSABLE PLASTIC DR0PPER
5. RUBBER TEATS
6. REFERENCE COLOUR INDEX
SETTING UP THE TEST:-
DILUTE THE CONCENTRATED WASHING
BUFFER (5X) TO I:5 WITH DISTILLED WATER BY ADDING 2ml
OF CONCENTRATED WASHING BUFFER TO 8ml OF DISTIILED
WATER.
ASSAY PROCEDURE
L THE KIT COMPONENT AND SAMPLES TO BE TESTED BROUGHT
TO ROOM TEMP.
1. SET THE FILTER PAPER SHEET ON THE TABLE.
2. MAKE THE 1% HYPOCHLORITE SOLUTION
3. MARK THE SAMPLE NUMBER ON MICROTEST WELL AND ADD
TWO DROPS OF SAMPLE DILUENT TO EACH MICROTEST WELL.
ADD TWO DROPS OF SAMPLE WITH THE HELP OF DISPOSABLE
PLASTIC DROPER/CONTROL TO EACH OF THE ABOVE WELLS
CONTAINING SAMPLE DILUENT.MIX SAMPLE WITH DILUENT BY
REPEATED ASPIRATION AND EXPELLING OR STIRRING WITH
DISPOSABLE PLASTIC DROPPPER.
5. TAKE REQUIRED NUMBER OF COMB AND MARK THE SAMPLE
NUMBER ON THE COMB.
6. PLACE THE COMB IN DILUTED SAMPLE BY HOLDING THE COMB
VERTICALLY WITH THE TEETH POINTING DOWN. SET THE TIMER
FOR 10 MIN.
IN THE MEAN TIME DILUTE THE CONCENTRATED WASHING
BUFFER (5X) TO I:5 WITH DISTILLED WATER BY ADDING 2ml
OF CONCENTRATED WASHING BUFFER TO 8ml OF DISTIILED
WATER.
AFTER 10 MIN REMOVE THE COMB AND BLOT VERTICALLY ON THE
ABSORBENT AND WASH FORWARD AND BACKWARD 10 TIMES IN
WASHING SOLUTION.
1. PLACE THE COMB IN THE WELL CONTAINING COLLIDAL GOLD
FOR 10 MIN.
10. TAKE THE COMB AFTER 10 MIN AND PLACE ON A CLEAN
SURFACE. ALLOW THE COMB TO AIR DRY COMPLETELY. AND NOTE
THE RESULT.
RESULTS: 1. PRESENCE OF PINK COLOURED DOT BOTH IN THE
TEST AND CONTROL INDICATE POSITIVE RESULT.
1. PRESENCE OF ONE DOT ON THE CONTROL INDICATES
NEGATIVE RESULT.
IF NO PINK COLOUR DOT APPEARED IN TEST & IN CONTROL THEN
THE TEST IS INVALID & HAS TO BE REPEATED.
ANNEXURE 1 MATERIAL PROVIDED WITH KIT:-
1. TEST DEVICE INDIVIDUALLY FOIL POUCHED WITH DESICCANT
2. ASSAY DILUENT
3. POSITIVE CONTROL
4. NEGATIVE CONTROL
5. CAPILLARY PIPETTE
6. PACKAGE INSERT
ACCESSORIES 1.WASH RESERVOIR
2. 8MICROWELL STRIPS
3. FOUR-ROW FRAME
4. DISPOSABLE PLASTIC DR0PPER
5. RUBBER TEATS
6. REFERENCE COLOUR INDEX
ANNEXURE 2
1% HYPOCHLORITE
ANNEXURE 3 EQUIPMENT
1. AUTO PIPPETE
ANNEXURE 4 SAFETY ISSUES
1. WEAR ALL PROTECTIVE BARRIERS LIKE
GLOVES
Comb aids rs
PROCEDURE:
1. SET THE FILTER PAPER SHEET ON THE TABLE.
2. MAKE 1% HYPOCHLORITE SOLUTION.
3. BROUGHT THE TEST KIT IN ROOM TEMP.
4. REMOVE THE TEST DEVICE FROM FOIL POUCH, PLACE
IT ON ON FLAT DRY SURFACE.
5. ADD 10ul SERUM OR PLASMA OR 20ul WHOLE BLOOD
SPECIMEN IN THE SAMPLE WELL.
6. ADD 4 DROPS (120ul) OF ASSAY DILUENT INTO THE
SAMPLE
WELL.
7.INTERPRET TEST RESULT IN 5-20 MIN.
WORK DESK INSTRUCTION
TRISPOT AIDSCAN
Bring all the kit and sample at room
temperature.
Set the filter sheet on the table.
Prepare hypochlorite solution.
Remove the required number of test device
from the pouch.
Place on a flat surface.
Label the test device.
Add 2 drop of buffer.
Add 2 drop of serum or plasma into the sample
window and allow soaking in.
Add 2 drop of gold conjucate into the sample
window.
Add 4 drop of buffer into the sample window.
Read result immediately do not after 5 min.
Sd bioline
PURPOSE :- TO DESCRIBE STEPWISE
INSTRUCTIONS OF Sd bioline
IN THE LABORATORY.
SCOPE :- TO DEFINE ALL THE DETAILED
INSTRUCTIONS OF. MERILINE.
IT IS THE RESPONSIBILITY OF THE LAB TECHNICIAN
TO PREPARE THE SOP AND GET IT APPROVED
FROM INCHARGE.
PRINCIPLE:- THE SD BIOLINE HIV TEST IS AN
IMMUNOCHROMATOGRAPHIC (RAPID) TEST FOR THE
QUALITATIVE DETECTION OF ANTIBODIES OF ALL
ISOTYPES (IgG, IgM, IgA) SPECIFIC TO HIV-1& HIV-2
SIMULTANEOUSLY IN HUMAN SERUM PLASMA .
SPECIMEN:- SERUM ,PLASMA..
PROCEDURE OF THE TEST:-
SET THE FILTER PAPER SHEET ON
THETABLE.MAKE1%HYPOCHLORITE SOLUTION.
HE TEST KIT IN ROOM TEMP.
1. REMOVE THE TEST DEVICE FROM FOIL
POUCH, PLACE IT ON A FLAT, DRY SURFACE.
2. ADD 10ul SERUM OR PLASMA OR 20ul
WHOLE BLOOD SPECIMEN IN THE SAMPLE
WELL.
3. ADD 4 DROPS (120ul) OF ASSAY DILUENT
INTO THE SAMPLE WELL.
4. INTERPRET TEST RESULT IN 5-20 MIN.
INTERPRETATION OF THE TEST:-
1. A COLOR BAND APPEARS IN THE LEFT
SECTION OF THE RESULT WINDOW TO SHOW
THAT THE TEST IS WORKING PROPERLY.THIS
BAND IS CONTROL LINE.
2. COLOUR BANDS WILL APPEAR IN THE
MIDDLE AND RIGHT SECTION OF THE RESULT
WINDOW.THESE BANDS ARE TEST LINE 2 AND
TEST LINE 1(2,1).
NEGATIVE RESULT
THE PRESENCE OFONLY CONTROLI WITH IN THE
RESULT WINDOW INDICATES A NEGATIVE
RESULT.
POSITIVE RESULTS
THE PRESENCE OF TWO LINES I AND TEST LINE 1
WITH IN THE RESULT WINDOW INDICATE A
POSITIVE RESULT FOR HIV 1.
THE PRESENCE OF TWO LINES I AND TEST LINE
2 WITH IN THE RESULT WINDOW INDICATE A
POSITIVE RESULT FOR HIV 2.
INVALID RESULT:- NO PRESENCE OF
CONTROL LINE I WITH IN THE RESULT WINDOW
INDICATES AN INVALID RESULT.
ANNEXURE 1 MATERIAL PROVIDED WITH KIT:-
1. TEST DEVICE INDIVIDUALLY FOIL POUCHED
WITH DESICCANT
2. ASSAY DILUENT
3. POSITIVE CONTROL
4. NEGATIVE CONTROL
5. CAPILLARY PIPETTE
6. PACKAGE INSERT
ANNEXURE 2
1% HYPOCHLORITE
ANNEXURE 3
EQUIPMENT
1. AUTO PIPPETE
ANNEXURE 4
SAFETY ISSUES
1. WEAR ALL PROTECTIVE BARRIERS LIKE
GLOVES
