Rapid HIV Testing in Delaware

1
CONTACT INFORMATION Robin L. Gorman Delaware
Public Health Laboratory 30 Sunnyside
Road Smyrna, DE 19977 Robin.Gorman_at_state.de.us Tel
302.653.2870 Fax [phone]
Rapid HIV Testing in Delaware
Frederick P. Franze, MT (ASCP), Robin L. Gorman,
MLT (ASCP), Jane P. Getchell, DrPH
ABSTRACT
INITIAL CONCERNS
QUALITY ASSURANCE
DELAWARE
In March 2003, the Delaware Division of Public
Health began rapid HIV-1 antibody testing at one
of the four STD clinics within the state. All
four sites were performing the test by June 2003.
Each of these clinics conducts moderate
complexity testing under a single CLIA
certificate that allows multiple state
laboratories to engage in limited public health
testing under one certificate. Prior to
implementation, the HIV program office worked
with the Public Health laboratory to develop a
comprehensive quality assurance program for rapid
HIV testing. The technical supervisor (TS) for
the STD clinics was tasked to develop appropriate
logs and training materials necessary to train
the staff. To decrease the chance of error,
clinics were trained and authorized to begin
testing one at a time. Beginning December 2004,
a community-based organization was authorized to
begin testing through a contract with the HIV
program office. This site is required to follow
the same training and QA as the state STD
clinics. Documents used for rapid testing
(training, QC, etc) were designed utilizing the
CDC QA guidelines. OraSure Technologies provided
training to our TS, who then provided training to
all public health staff involved in testing.
Training was conducted in the following manner
first the laboratory staff were trained to
perform the test and competency assessment was
documented, then the HIV program office held a
meeting with lab staff, clinicians and counselors
to discuss protocols for testing and reporting.
Once it was determined that all staff were ready
to begin, permission was granted to begin testing
patients. The first 100 patients tested using
rapid tests were backed up with ELISA to validate
the method. The virology section of the Public
Health laboratory put together several sets of
unknowns for proficiency testing. All staff
wishing to perform rapid testing were required to
successfully interpret the results of these
samples. Quality assessment consists of the
following - On-going QC measures as required by
the manufacturer - Proficiency testing using the
CAP Anti-HIV-1 antibody waived survey (RHIVW) -
CDC MPEP for rapid testing - Semi-annual
inspections of the five laboratories involved in
testing by the TS All preliminary positive rapid
tests are sent to the state public health
laboratory for confirmatory Western Blot
test. For calendar year 2004, Delaware tested
6141 patients, with 78 confirmed preliminary
positives and two false positive rapid tests. All
five testing locations successfully passed all
proficiency testing surveys and no erroneous
results due to technician error were reported.

• Training Who would be responsible for training
  clinic staff to perform testing? Who should be
  trained?
• - The technical supervisor for the STD clinic
  labs was tasked with the responsibility
• - Initially, only lab techs would be trained to
  perform the test.
• Validation How do we want to validate the test?
• - The first 100 patients tested using rapid tests
  were backed up with ELISA testing
• Quality Control At what intervals should QC be
  performed?
• - External quality control to be done at the
  following intervals
• Weekly for staff who perform the test on a daily
  basis
• Each day of testing for staff who perform the
  test on an irregular basis.
• - Quality control is to be performed whenever a
  new lot of kits is received put into use.
• - Whenever testing personnel suspect there may be
  a problem with the test kits.
• Proficiency Testing (PT) What PT surveys should
  be performed?
• - All sites were enrolled in the College of
  American Pathologists PT survey for rapid HIV
  testing (RHIVW)
• - All sites participate in the CDC Model
  Performance Evaluation Program (MPEP) for rapid
  HIV testing.
• - Survey participation and performance is
  monitored by the technical supervisor.

• The STD clinic labs perform testing under the
  CLIA Limited Public Health Use Exception
  (certificate).
• Allows multiple laboratories to engage in public
  health testing under one certificate.
• Provides unique opportunity to implement a
  comprehensive quality assurance program for all
  sites performing rapid HIV testing throughout the
  state. Performance is monitored via semi-annual
  inspections.
• DE Quality Assurance program consists of the
  following
• - Standardized SOPs for all testing sites.
• - All clinical staff trained to perform the rapid
  test must demonstrate competency prior to testing
  patients.
• - All sites are enrolled in College of American
  Pathologists PT surveys for rapid HIV-1 antibody
  testing (RHIVW).
• - All sites participate in the CDC Model
  Performance Evaluation Program (MPEP) for HIV
  rapid testing.
• - All sites test commercially prepared Quality
  Controls (Positive Negative) as specified in
  the SOP manual.
• - All Preliminary Positive specimens are sent to
  the Virology section of the DPHL for confirmatory
  Western Blot testing.
• - Discordant (false positive) rapid test results
  are investigated to ascertain the cause.

Testing Statistics 2004
Test Location County Population Total Tests Performed PP Confirmed
Porter State Service Center Wilmington (New Castle County) 515,074 2395 28 28
Beautiful Gate Outreach Center (community-based organization) Wilmington (New Castle County) 515,074 1019 25 25

Kent County Health Unit Dover (Kent County) 134,390 1782 6 6

Sussex County Health Unit Georgetown (Sussex County) 168,027 748 19 18
Shipley State Service Center Seaford (Sussex County) 168,027 197 3 2
TRAINING

• Division of Public Health
• STD Clinic Lab Inspection Report
• Facility ________________________ Date
  ______________
• Administrative ensure that the required manuals,
  logs certificates are available as required.
• a. Laboratory SOP manual
• Located in lab and available? Y N
• Reviewed by all staff performing tests? Y N
• (indicated by staff signature)
• b. Problem / Sharps Injury Log
• Located in lab? Y N
• Any entries requiring review/action? Y N
• c. Is the CLIA Laboratory Certificate of
  Compliance posted? Y N
• 2. Quality Control / Maintenance Records ensure
  that QC and maintenance records are completed as
  required, and available for review.
• a. Gram Stain QC performed as required? Y N
  N/A
• b. Syphilis Serology QC performed as required?
  Y N N/A
• c. Rapid HIV QC performed as required? Y N
  N/A
• d. Refrigerator, Incubator room temps
  recorded? Y N
• Are problems with QC/ maintenance documented as
  required and is
  the problem resolved? Y N

The OraQuick rapid HIV-1 antibody test training
program was implemented in the following manner
- OraSure Technologies provided initial training
to the technical supervisor for the STD clinic
labs. - The technical supervisor provided
training to the laboratory technicians at each of
the STD labs utilizing a video tape of the test
procedure and hands-on training. - To be
certified to begin patient testing, lab staff had
to demonstrate proficiency by accurately
interpreting the results of several unknown
specimens. - Documentation was accomplished
using a modified version of the CDC training
checklist for the OraQuick rapid HIV-1 antibody
test. - After staff were certified to perform
testing, the HIV program office and the Public
Health lab held a meeting with clinicians,
counselors and testing personnel to discuss
protocols for testing and reporting.
TEST RESULT OBSERVATIONS
Since beginning rapid testing in March 2003, the
five site labs have performed 9,058 tests. Of
the 117 tests reported as preliminary positive,
110 were confirmed by Western Blot. The remaining
seven tests were determined to be false positive
results. During this time the following
observations were made - Preliminary positive
rapid tests that were confirmed positive by
Western Blot usually demonstrated a clear, strong
band at the T region within two to five minutes
after the test began. - Several
false positive specimens were sent to OraSure
Technologies for evaluation. It was determined
that the patients had a non-specific binding
antibody that reacted with proteins used in the
test paddle matrix.
Delaware Public Health Laboratory Training
Checklist for the OraQuick Rapid HIV-1 Antibody
Test Employee _________________________________
Clinic ________________________ Trainer
____________________________________
Instructions Fill in dates when the trainee
observes and performs each objective or
procedural step, as applicable. (If a trainee
will not perform a specific task, enter N/A for
not applicable) The trainee should initial when
he/she feels the objective/procedure has been
mastered and the trainer when he/she thinks the
trainee has met the objective or performs the
specific procedure competently.
BACKGROUND

• In January 2003, the FDA approved the OraQuick
  rapid HIV-1 antibody test as a CLIA-waived test.
  In March 2003 the Director of the Division of
  Public Health gave approval to the HIV program
  office and the Public Health laboratory to begin
  implementing rapid HIV-1 testing throughout the
  state. The rationale for granting quick approval
  to implementation was based upon the fact that in
  calendar year 2002, approximately 10,000 HIV
  tests were performed (both anonymous and
  confidential), but 46 of the clients failed to
  return for their results. This created a
  situation whereby a large population is
  potentially at risk of infection and dont know
  it. It is believed that the primary reason for
  this high failure to return rate was the long
  turn around time (two weeks) for results. By
  implementing rapid testing at the clinic sites,
  clients will be able to learn their HIV status
  immediately, allowing clinic staff an opportunity
  to discuss risk reduction and behavior change.
• Beginning March 2003, STD clinics were authorized
  to begin testing, one at a time. As each site
  began testing, close, coordinated communication
  was maintained between the HIV program office,
  the Public Health lab and the clinic staff to
  resolve any problems or issues as they occurred.
  By June 2003, all four of the STD clinics were
  performing testing. In December 2003, a
  community-based organization (CBO) was authorized
  to begin testing.
• To facilitate implementation of rapid testing,
  the HIV program office worked with the Public
  Health laboratory to develop a coordinated
  approach. Responsibilities for each included
• HIV Program Office
• - Provide the funding to purchase test kits,
  controls, training materials and Proficiency
  Testing surveys.
• Determined which clinic sites would be
  authorized to perform the testing and who would
  be trained to perform testing (clinicians,
  counselors, etc).
• Public Health Laboratory
• - Designated the STD clinic lab technical
  supervisor as the authorized individual to train
  and certify public health staff to perform rapid
  testing.
• Developed the appropriate logs and training
  materials.
• Monitors the following quality assurance
  activities at each of the authorized testing
  locations quality control, PT surveys and
  technician performance.
• Maintains and distributes rapid testing supplies
  to test sites.

Objective / Procedural Step Date Performed Trainees Initial and Date Trainers Initials and Date
Read OraQuick procedure and view rapid test training video
Determine if requirements for acceptable testing environment are met (temperature, lighting, proper work space
Practice test with negative and positive external controls
Explain requirements for Subject Information brochure
Label test device components and appropriate paperwork
Collect finger-stick specimen, put loop into vial and mix correctly
Dispose of lancet and other biohazardous waste appropriately
Insert test device, time test, correctly interpret result
Record results on report form and log sheet route report form copies results appropriately
Record external quality control (QC) results in QC log
Evaluate a new OraQuick test kit lot number and record results in QC log
Collect send specimen for confirmatory testing at DPHL
Explain procedure to follow if QC results indicate a problem
Perform proficiency test proved by DPHL and obtain correct results

CONCLUSIONS
Through the use of the CLIA Limited Public Health
Use Exception (certificate), the Delaware Public
Health laboratory was given the unique
opportunity to implement and monitor a
comprehensive quality assurance program for all
sites performing the rapid HIV test throughout
the state. Key components of this QA program
include ? Standardized training program for all
testing sites ? Standardized quality control
requirements for all sites ? Standardized
proficiency testing program. ? Standardized
testing and reporting procedures for all clinic
sites. ? Standardized requirements for
confirmation testing of preliminary positive
results and follow-up of discordant results The
creation of a standardized quality assurance
program, run by a single technical supervisor,
who is able to monitor the performance at all
testing sites, has been instrumental in assuring
that no erroneous results due to technician error
have occurred.
REFERENCES

• OraSure Technologies, Inc. OraQuick Rapid HIV-1
  Antibody Test Package Insert (Rev. 10/03)
• CDC Quality Assurance Guidelines for Testing
  Using the OraQuick Rapid HIV-1 Antibody Test