Transcript Test Spot - SFHIV.ORG

INSTI HIV 1 Rapid Test
How To Run and Read
Overview
 Background Presentation
 Demo of the test
 You will practice running 2 tests
We will not be testing anyone in the room
 Proficiency Test - You will run 5 tests without
assistance
Run, read, and document 5 tests
Read results of 12 test images (?)
Pass / fail course, must get 100% to pass
What do you know about
rapid HIV tests?
Intro to INSTI Rapid Test
 Screening test
 Visual interpretation
 Looks for HIV antibodies
 Uses blood
 Results in 1 minute
In California….
 Individuals who have been trained by CDPH/OA and are
working in a OA-funded HIV testing site can run HIV/Hep C
rapid tests
OR
 Are working in an HIV testing site that meets these two
criteria:
 Utilizes HIV counseling staff who are trained by OA or its
agents and
 Has a quality assurance plan (QA) approved by the local health
department in the jurisdiction where the site is located and has
HIV testing staff who comply with specific QA requirements.*
 They must also be certified to perform finger sticks (or be
occupationally exempt, like nurses)
* QA requirements are specified in Section 1230 of Title 17 of the California Code of Regulations
Package Insert
 Contains instructions
 CLIA requires following
the manufacturer’s
instructions to the
letter!!
Subject Information Notice
 Contains information
about the test that is
relevant to the client
 Package Insert says,
“All subjects must
receive the Subject
Information Notice”
 Check in with your site
to see how this is
handled
Test Accuracy
 We’re going to talk about how well the test
works
 You do not need to memorize the details
- only need to know test is very accurate
 There are two components of test accuracy:
Sensitivity
Specificity
Specificity
 When a test finds something, it should be the
right thing
 Tests ability to detect a true negative
Specificity
Total
True
negatives
INSTI
negatives
Difference
% Specific
1408
1382
1375
7
99.5%
Not exact, but
very accurate
Sensitivity
 The ability of a test to find what it’s looking
for and not miss anything.
 Test’s ability to detect a true positive
Sensitivity
Total
Confirmed
positives
INSTI
reactives
Difference
% Specific
3507
820
817
3
99.6
INSTI
test
The test’s ability to
detect true positives
and not miss anything
Combining
Specificity and Sensitivity
An ideal test would find the right thing
(specificity)
and not miss anything
(sensitivity)
Think of a Tuna net….
A net that gets all the tuna and none
of the dolphins
Because the Test is
Highly Sensitive…
 We do not need to confirm negatives
 We do, however, always need to confirm
reactive and preliminary positives
2 Different Tests
INSTI
1st Test
_
Negative,
please come back
and see us in 6 months
+
++
OraQuick Test
Reactive, 2nd Test
_
Lab Testing
Both tests were reactive
your next step is to see
a doctor and we can
help you with that
With Clients…
 Emphasize that the
test is extremely accurate
 De-emphasize statistics and
percentages
 For example “This test is highly
accurate”
Quality Assurance
Requirements
 QA are practices and procedures which
ensure that every client receives an accurate
test result
 QA reduces human error as
much as possible
Components of
Quality Assurance
 Personal and logistical characteristics
 External controls
 Lab space
 Universal precautions
Must Have…
Steady hand
Good eye sight
Organizational skills
Adequate lighting
 Full/bright light, task light
 Do not use a flash light
External Controls
 Fluids made from
inactivated human
plasma
 Biohazards –
wear gloves!
 Negative,
Positive for HIV-1
External Controls are Used for:
 Training, we will use them today
 Determining if test is working properly
 Determining if lighting is adequate
 Determining if the test reader has sufficient
eye site
HIV-1 vs HIV-2
 Two different strains
 Both are transmitted the same way
 HIV-2 is less infectious
 HIV-2 progresses more slowly
 HIV-2 found in West Africa and is rarely found
elsewhere
HIV-1 vs HIV-2
 Two different strains
 Both are transmitted the same way
 HIV-2 is less infectious
 HIV-2 progresses more slowly
 HIV-2 found in West Africa and is rarely found
elsewhere
When to Run
External Controls
 New operator
 New test kit lot or shipment
 Two invalid results in a row
 Out of temperature range in testing area or
in storage area
 Every 40 tests or once a month
(whichever comes first)
Temperature
Control
 Perform test,
59 to 86 degrees
 If testing temperature is out of required
temperature range stop testing
 If out of temp range, run controls before
proceeding
 Store test: 59-86 degrees
Lab Space
A space for undisturbed test processing
 Your site is a lab
 Separate from counseling area
 No smoking, eating or drinking
Universal Precautions
The universal practice of avoiding contact
with patients' bodily fluids, (blood) by means
of the wearing of nonporous articles such as
medical gloves
Gloves
 Wear them when handling blood or blood
products
 TODAY – whenever you touch the
control fluid vials!!!!
 How often do
 you change them?
 How do you remove them?
Sharps: Handling & Disposal
 Medical instruments that are used to
puncture the skin (syringes, lancets,
needles)
 Dispose of sharps immediately,
in a hard red plastic bio bin!
 Do NOT dispose of sharps
in a red bio hazard bag
Biohazard Bags
Handling & Disposal
 Bandages, used cotton and
gauze, and gloves with body
fluids on them are bio
hazardous waste
 By law, if fluid cannot be
squeezed out of the cotton,
gauze, etc., the waste item
can be disposed of in regular
trash.
For Today’s Training
 Place pipettes and
used test kits in the
sharps container
 Place gloves and all
other trash in the
brown paper bag
Paperwork Needed
 Expanded Checklist
 Short Checklist (Competency
Assessment Test)
 Rapid testing log or lab slip
 Lab stickers
 HIV Testing Form
Always use blue or black ink only!
Basic
Materials
3 solutions
Test device
Pipette and lancet
Package
insert
The Test Device
Control spot
Test spot
THIS TAB DOWN
How to Run INSTI Controls
1.
2.
3.
4.
Bring controls to room temperature
Mix controls by swirling
Collect 50ul (microliters) in clean pipette
Transfer control sample to Sample Diluent bottle (#1- a
diluting agent)
5. Mix by inversion
6. Pour into center of membrane within 5 minutes (absorbs in
30 seconds)
7. Mix Color Developer (#2) by inverting
8. Check that Color Developer suspension is thoroughly mixed
9. Pour Color Developer into center of membrane (absorbs in
20 seconds)
10. Add Clarifying Solution (#3) to center of membrane, read
result immediately while membrane is still wet
11. Do not read if 5 minutes have passed after adding Clarifying
Solution
Why INSTI is a 1-Minute Test
 30 seconds for the first step
 20 seconds for the second step
 10 seconds or less for the third step
Trainers Demonstrate
 Trainer Reads
 Other Trainer preforms test
 Participants follow along
(Expanded Checklist)
Participants’ First Practice
 No food or drink
 Listen to detailed steps:
Only do what we tell you to do
The time it takes between introducing
the fluids is important
Do all steps in order
If you finish step a quickly, wait for
the next step, unless time-sensitive
Negative Result
 After Clarifying
Solution (#3) has
been absorbed,
control spot is
shaded, test spot
is not
 Light or dark, still
negative
THIS TAB DOWN
THIS TAB DOWN
Negative Result
Rarely a faint
ring will appear
around the test
spot. This is still
a negative result.
THIS TAB DOWN
Reactive Result
 After Clarifying
Solution (#3) has
been absorbed,
control spot is
shaded, test spot
is also shaded
 Test spot must be
completely
shaded, light or
dark
THIS TAB DOWN
Indeterminate Result
After Clarifying Solution (#3) has been absorbed:
control area
is not shaded
THIS TAB DOWN
membrane displays
“uniform tint” or “blue specks”
THIS TAB DOWN
THIS TAB DOWN
THIS TAB DOWN
What causes invalids?
 Human error (e.g., no specimen)
 Unknown
 Manufacturer error
 If you ever have an unusual result, do not
deliver it
What does it mean if a
client has an invalid test result?
What does the darkness of the
spots mean?
NOTHING
Results (change to INSTI)
Participants’ Second Practice
 Pair up
One person run a test at their own pace, using
the short checklist
Partner observe them and help only as needed
(e.g., if you see any steps that were missed, say
something)
Switch
 Use the checklist!!!!
Internal Control –
the Control Spot
 Internal control tells us:
 Specimen was adequately applied
 Proper absorption of solutions
Internal & external controls are standard lab
practice – not a sign of test kit unreliability
Test Spot
 It works with the external control fluids to:
tell us if the result is reactive or non-reactive
tell us if reader can see spots
tell us if there is proper lighting
tell us if the reader’s eyesight is adequate to
run the test
Controls Work Together
 If the internal control (control spot) & the
external controls (control fluids) both tell us the
test kit is working, why do we need both?
 Because they tell us something different!
The Control Spot tells us test kit is working
properly
The Test Spot tells us the test kit can detect
HIV antibodies when they’re present
Results of Practice Test
 Did you get the correct result?
 Any questions?
 The control fluid that we use provides a
“challenge sample”
A light test spot verifies lighting is OK
Verifies test kit detecting small amount of antibody
Darkness of test spot NOT related to viral load,
disease progression, or anything else about the
client
If a Client Asks to See the
Test Kit, What Would You Do?
 Say “No”
–
Why?
 Could compromise confidentiality
 Only trained personnel may read the test
 Test is disposed of in biohazard bag as soon as
it’s read
How Do You Correct a
Written Mistake?
 Use blue or black ink only on all forms
 A single crossed-out line, corrected entry written
clearly above, include date and initials of the
individual making the change
 At no time should an original entry be obliterated
or otherwise made illegible by a change on the
record
7:22pm T.K. 12/15/2011
End time: 7:12pm
Any questions?
Proficiency tests coming next….
INSTI HIV Test Proficiency:
Words of Caution
 Follow the checklist!!!!
 This is not a test of memorization
 Run five tests using five different controls
 Put your name on the top of your paper(s)
 Take your time, double & triple checking your work
 If you make a mistake on your paperwork
 and you catch it, you can fix it.
 and I catch it, you will have to come back another day
Additional Resources
 The current package insert (including instructions for
operation) for the BioLytical INSTI HIV1Rapid test
 http://www.biolyticalus.com/instructions.html
 The California Quality Assurance Guidelines are available
on the Office of AIDS website at:
http://www.cdph.ca.gov/aids