HIV Rapid Test Procedures and Instructions

 
Check kit before use. Use only items that have not expired or been damaged.
Bring kit and previously stored specimens to room temperature prior to use.
Always use universal safety precautions when handling specimens.  Keep work areas clean and organized.
This outline does not replace the product insert or your standard operating procedure (SOP).
 
Determine HIV -1/2 Rapid Test
(For use with whole blood, serum, or plasma)
 
Collect all necessary
supplies.
 
Use 1 strip per client. Record lot #
and expiry date in the register.
 
Label the test strip with
client ID number.
 
Store kit:
2 - 30° C
 
Pull off the protective foil
cover.
 
Collect  50 µl of specimen
using either a capillary tube or
precision pipette.
 
Apply the specimen to the
absorbent pad on the
strip.
 
For whole blood only add drop
of chase buffer to the specimen
pad.
 
Wait 15 minutes (no longer
than 60 minutes) before
reading the results.
 
Read and record the results
and other pertinent info on
the worksheet.
 
Reactive
2 lines 
of any
intensity appear
in 
both
 the
control
 and
patient
 areas.
 
Non-reactive
1 line 
appears in
the 
control
 area
and no line in the
patient area.
 
Invalid
No line appears in the
control
 area.
Do not report invalid
results. Repeat test with
a new test device even if
a line appears in the
patient area.
 
Check kit before use. Use only items that have not expired or been damaged.
Bring kit and previously stored specimens to room temperature prior to use.
Always use universal safety precautions when handling specimens.  Keep work areas clean and organized.
This outline does not replace the product insert or your standard operating procedure (SOP).
 
Uni-Gold HIV -1/2 Rapid Test
(For use with whole blood, serum, or plasma)
 
Store kit:
2 - 30° C
 
 Reactive
2 lines 
of any
intensity
appear in
both
 the
control 
and
test 
areas.
 
Non-reactive
1 line 
appears in
the 
control 
area
and no line in
the test area.
 
Invalid
No line
appears in the
control 
area.
Do not report
invalid results.
Repeat test
with a new
test device
even if a line
appears in the
test area.
 
Collect test items and
other necessary lab
supplies.
 
Remove device from package
and label device with client
identification number.
 
Collect specimen  (blood
or plasma or serum using
the disposable pipette.
 
Add 2 drops (approx. 60µl)
of specimen to the sample
port in the device.
 
Add 2 drops (approx. 60µl)
of the appropriate wash
reagent to sample port.
 
Wait for 10 minutes (no longer
than 20 min) before reading
the results.
 
Read and record the results
and other pertinent info on
the worksheet.
 
C
 
T
 
C
 
 
Check kit before use. Use only items that have not expired or been damaged.
Bring kit and previously stored specimens to room temperature prior to use.
Always use universal safety precautions when handling specimens.  Keep work areas clean and organized.
This outline does not replace the product insert or your standard operating procedure (SOP).
 
Bioline HIV -1/2 Rapid Test
(For use with whole blood, serum, or plasma)
 
Store kit:
1 - 30° C
 
 
Collect test items
and other necessary
lab supplies.
 
Remove device from package
and label device with client
identification number.
 
Use a precision pipette
to collect 10 µL of
serum or plasma
 
Use a disposable capillary
pipette to draw 20 µL of
whole blood up to fill line
 
Apply the serum, plasma or
whole blood specimen to the
sample well of the test device.
 
Add 4 drops of the
Assay diluent to the
sample well.
 
Start timer and read the test results
within 10 to 20 minutes. Don’t read
test results after 20 minutes.
 
Read and record the results and
other pertinent info on the
worksheet.
 
Reactive
Presence of 
2
(“C”, “1” and
“2”)
 or
more lines
within the
Result window.
 
Non-reactive
1 line 
appears
in the 
control
(“C”) 
area and
no line in the
Test area.
 
Invalid
No line 
appears in
the 
control (“C”)
area. Do not report
invalid results.
Repeat test with a
new test device
even if a line
appears in the client
area.
 
 
 
 
 
 
 HIV1              HIV 2          HIV 1/2
 
Finger Prick – JOB AID
 
Position hand palm-side up.
Choose  least calloused finger
(either middle or ring finger)
 
Apply intermittent pressure
to help the blood flow
 
 
 
Wipe away the 1st drop of
blood with  a sterile gauze pad
or cotton ball
 
If necessary, apply
intermittent pressure on
opposite side of finger for
blood to flow
 
Apply a gauze pad or cotton
ball to the puncture site until
the bleeding stops
 
Ask client to rub/massage
hands together.  Ensure
the clients hands are warm
to touch.
 
Properly dispose of all
contaminated supplies.  Do
not retrieve anything from
the waste containers.
1
2
3
 
Collect all necessary
lab supplies.
 
Examine tube. Make sure
the green colored dried
specimen is present and
sits at the bottom of the
tube.
 
If not, tap the tube until
the specimen is visible at
the bottom.
 
DRIED TUBE SPECIMEN (DTS) – JOB AID
4
5
6
 
Open the tubes only
when the specimen
appears at the
bottom
.
 
Using a disposable
pipette, add 5 drops
(~200µL)  of “PT buffer”
to the dried tube
specimen.
 
Cap the tubes.
7
8
9
 
Tap the tubes to
mix well.
 
Leave tubes standing
upright at room
temperature
overnight.
 
The next day, tap
tubes to mix and test
according to testing
procedures and
algorithm.
 
Note:
Reconstitute only when you are ready to test the DTS panel the next day.
Record the results on the Results submission form and send to the reference lab.
 
Module 7. Proficiency Testing Programs
 
Handout # 7.1H1
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This content provides detailed instructions for conducting HIV rapid tests using three different kits: Determine HIV-1/2 Rapid Test, Uni-Gold HIV-1/2 Rapid Test, and Bioline HIV-1/2 Rapid Test. The instructions include steps such as specimen collection, test device preparation, result interpretation, and handling invalid results. Each kit has specific guidelines for sample collection and result interpretation, emphasizing the importance of following safety precautions and ensuring kit integrity. Images of the test kits are also included for visual reference.


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  1. Determine HIV -1/2 Rapid Test (For use with whole blood, serum, or plasma) Store kit: 2 - 30 C Check kit before use. Use only items that have not expired or been damaged. Bring kit and previously stored specimens to room temperature prior to use. Always use universal safety precautions when handling specimens. Keep work areas clean and organized. This outline does not replace the product insert or your standard operating procedure (SOP). Label the test strip with client ID number. Collect all necessary supplies. Use 1 strip per client. Record lot # and expiry date in the register. http://i1.ytimg.com/vi/wwcx2DVXHFM/hqdefault.jpg http://www.alere.co.uk/images/product/thumbs/1_prod_43ebe78a7aed2dfb478c3674bf662a3c.jpg Apply the specimen to the absorbent pad on the strip. Collect 50 l of specimen using either a capillary tube or precision pipette. Pull off the protective foil cover. For whole blood only add drop of chase buffer to the specimen pad. Read and record the results and other pertinent info on the worksheet. Wait 15 minutes (no longer than 60 minutes) before reading the results. Reactive 2 lines of any intensity appear in both the control and patient areas. Non-reactive 1 line appears in the control area and no line in the patient area. Invalid No line appears in the control area. Do not report invalid results. Repeat test with a new test device even if a line appears in the patient area.

  2. Uni-Gold HIV -1/2 Rapid Test (For use with whole blood, serum, or plasma) Store kit: 2 - 30 C Check kit before use. Use only items that have not expired or been damaged. Bring kit and previously stored specimens to room temperature prior to use. Always use universal safety precautions when handling specimens. Keep work areas clean and organized. This outline does not replace the product insert or your standard operating procedure (SOP). Collect test items and other necessary lab supplies. Remove device from package and label device with client identification number. Collect specimen (blood or plasma or serum using the disposable pipette. Add 2 drops (approx. 60 l) of the appropriate wash reagent to sample port. Wait for 10 minutes (no longer than 20 min) before reading the results. Add 2 drops (approx. 60 l) of specimen to the sample port in the device. Read and record the results and other pertinent info on the worksheet. Invalid No line appears in the control area. Do not report invalid results. Repeat test with a new test device even if a line appears in the test area. Reactive 2 lines of any intensity appear in both the control and test areas. Non-reactive 1 line appears in the control area and no line in the test area. C C T

  3. Bioline HIV -1/2 Rapid Test (For use with whole blood, serum, or plasma) Store kit: 1 - 30 C Check kit before use. Use only items that have not expired or been damaged. Bring kit and previously stored specimens to room temperature prior to use. Always use universal safety precautions when handling specimens. Keep work areas clean and organized. This outline does not replace the product insert or your standard operating procedure (SOP). Collect test items and other necessary lab supplies. Remove device from package and label device with client identification number. Use a precision pipette to collect 10 L of serum or plasma Apply the serum, plasma or whole blood specimen to the sample well of the test device. Add 4 drops of the Assay diluent to the sample well. Use a disposable capillary pipette to draw 20 L of whole blood up to fill line Start timer and read the test results within 10 to 20 minutes. Don t read test results after 20 minutes. Read and record the results and other pertinent info on the worksheet. HIV1 HIV 2 HIV 1/2 Reactive Presence of 2 ( C , 1 and 2 ) or more lines within the Result window. Non-reactive 1 line appears in the control ( C ) area and no line in the Test area. Invalid No line appears in the control ( C ) area. Do not report invalid results. Repeat test with a new test device even if a line appears in the client area.

  4. Finger Prick JOB AID Ask client to rub/massage hands together. Ensure the clients hands are warm to touch. Position hand palm-side up. Choose least calloused finger (either middle or ring finger) Apply intermittent pressure to help the blood flow Hold the finger and firmly place a new sterile lancet off-center on the fingertip Firmly press the lancet to puncture the fingertip Disinfect fingertip. Start in the middle and work outward to avoid contamination. Allow to dry Wipe away the 1st drop of blood with a sterile gauze pad or cotton ball If necessary, apply intermittent pressure on opposite side of finger for blood to flow Apply a gauze pad or cotton ball to the puncture site until the bleeding stops Properly dispose of all contaminated supplies. Do not retrieve anything from the waste containers.

  5. DRIED TUBE SPECIMEN (DTS) JOB AID Examine tube. Make sure the green colored dried specimen is present and sits at the bottom of the tube. If not, tap the tube until the specimen is visible at the bottom. Collect all necessary lab supplies. 2 3 1 Cap the tubes. Open the tubes only when the specimen appears at the bottom. Using a disposable pipette, add 5 drops (~200 L) of PT buffer to the dried tube specimen. 5 6 4 The next day, tap tubes to mix and test according to testing procedures and algorithm. Tap the tubes to mix well. Leave tubes standing upright at room temperature overnight. 7 8 9 Note: Reconstitute only when you are ready to test the DTS panel the next day. Record the results on the Results submission form and send to the reference lab. Module 7. Proficiency Testing Programs Handout # 7.1H1

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