rHIVda-Rapid HIV

Diagnostic Algorithm
rHIVda:

is a testing algorithm of sequential

combination of two to three test (immuno-
assay and /or rapid tests)that can reliably use
to confirm HIV test result.
Is a testing combination that can be done on
an initially reactive sample.
General Objective :

To provide policies and guidelines in the

conduct of rapid HIV diagnosis at health facility
setting

 To provide a quicker result to confirm HIV result

 To increase access , reduce undiagnosed cases
 To increase immediate linkage to medical care and
treatment
rHIVDA Testing Algorithm
Non-CrCL (OTHER
HIV Testing
Laboratories)
Certified rHIVda
ConfirmatoryLaboratory

(+) (-)
Screening Test Nonreactive
Refer
Release result
(T0)

If T0 is a 3rd
generation test Nonreactive
Test 1 (-) Release result as HIV NEGATIVE
(T1)
Repeat test after 6 weeks *
If T0 is a
4thgeneration
(+) test

Test 2 (-) Nonreactive, Release result as HIV NEGATIVE

(T2) Recommend repeat test after 6 weeks*
Send sample to NRL-SLH/SACCL

(+)

(-)
Test 3 Consider as INCONCLUSIVE**
(T3) Do not release the result
Refer sample/patient to NRL-SLH/SACCL

(+)

Release Result as
HIV POSITIVE

* Repeat test using new sample to

verify the antigenemia in T0
**Validation of the performance of tests
in T1 and T2 is required
Scope of application:

 The administrative Order covers all HIV providers ,

coordinators , managers and supervisors of HIV clinics
and /or testing laboratories , all government and private
facilities offering HIV testing for diagnostic purposes. The
rHIVda is intended to be used in both the general and key
populations.
General Guidelines:

 Clinical laboratories of HTS shall be assessed for their qualification to implement

rHIVDa and monitored for their continued compliance to the QMS standard
criteria. The certification for rHIVda laboratories shall require compliance to the
standard criteria set by the NRL- SLH/SACCL (Bio-freezer for specimen
handling and storage)
 Clinical laboratories of Treatment/Satellite Hubs, Social Hygiene Clinics as well
as designated private clinical laboratories that have qualified as CrCLs will
undergo training on rHIVda Implementation.
 HIV testing laboratories that are non-CrCLs shall refer reactive specimens to the
CrCLs following the existing guidelines and procedures.
 The selection of the rapid HIV test kits and development of diagnostic algorithms
is the responsibility of the DPCB/NASPCP and the NRL- SLH/SACCL.
General Guidelines:
 Quality management systems of all CrCLs shall be developed and maintained.
 Supervision and technical support shall be provided to all CrCLs and all HTS that express intent to
establish rHIVDa implementation.
 HTS involved in the diagnosis and care of PLHIV are encouraged to set-up within their systems
provision for rHIVda.
 Pre- and post-HIV test counseling shall be appropriately conducted to all clients seeking HIV testing.
 Right to confidentiality of information of persons seeking HIV testing shall be observed by all health
care workers and shall maintain safety and security of documents, reports and records in the CrCLs.
 All initially reactive and confirmed PLHIV shall be linked to prevention, treatment and care services.
 All CrCLs shall be capacitated to use the eHARP for timely reporting of data gathered in the required
EB Forms A and A-MC.
Testing is done in the HIV Testing facility
Testing facility is assessed with proper certification
and LTO that is certified by NRL-SACCL
The test is performed by a certified Medical HIV
Proficient Medical Technologist
Time line for roll-out
 -Policy
End of 2017-all treatment hubs and at least 40 category A cities

2018- remaining cat A sites

2019-cat Band C sites
2020- ALL are rHIVda sites

-by the end of 2017 – Draft of MOA between DOH and LGU
-2018: Signed MOA
REGULATION
 CERTIFICATION
All rHIVda sites compliant for certification
2018-all rHIVda sites must be certified- category A Sites
2019-remaining category sites

 Licensed to Operate – all rHIVda sites shall secure LTO

A 2 year timeline is given for completion of requirements for LTO
FINANCING- Test kits approved by BFAD will be provided by
the program
Roles and responsibilities of DOH-
Regional Office:
 a. Local Health Support Division (Program)
 Advocate the setting up of rHIVda in local government units in areas identified
to have current or potentially high-prevalence rate of HIV.
 Provide training, mentoring and coaching to CrCLs following national program
policies and direction.
 Conduct monitoring and evaluation activities and supervise implementation of
rHIVDa.
 Strengthen linkage and continuum of community-based and hospital-based
services of diagnosis, medical care and Antiretroviral Therapy.
 Provide technical assistance to testing sites to ensure their readiness for licensing
and accreditation (laboratories, clinical facilities) or site registration (stand-alone
sites, community programs).
 b. Regulations, Licensing and Enforcement Division (RLED)
 Inspect all facilities conducting rHIVDa.
 Issue License to Operate to facilities that meet standards and
requirements for rHIVDa.
 Monitors compliance to regulatory standards.
 Conduct surveillance of unlicensed laboratory facilities.

 c. Regional Epidemiology and Surveillance Units (RESU)

 Monitor rHIVda implementation.
 Conduct surveillance of cases.
 Assist LGUs in the mapping of hotspots.