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8/12/2019 Operational Guideline for HIV 2 Diagnosis
1/14
8/12/2019 Operational Guideline for HIV 2 Diagnosis
2/14
Instructions to be followed byART centers for referring clients/patients for HIV 2 diagnosis
(RefertoFlowchart):
I. Clients/PatientswiththefollowingreportfromtheICTCSpecimenispositiveforHIVantibodies
(HIV
1and
HIV
2;
or
HIV
2alone)
(Annexure
8)
will
be
referred
to
the
nearest
ARTcentreforregistration.
II. TheARTcentrewillthenreferthesaidclient/patienttothedesignatedHIV2referrallaboratory asperAnnexure1
III. ThepatientmustcarryICTCreportandareferralslip(Annexure2)dulysignedbytheARTMedicalOfficeralongwithaphotoIDtothereferrallabonanyworkingdayfromMonday
toFridaybetween9:00AMto2:00PM.
IV. TheHIV2referrallabwillcollectfreshbloodspecimen(serum+plasma) forHIVserostatusconfirmation
V. SpecimenwillbetestedbyreferrallaboratoryasperthenationalalgorithmforHIV2serodiagnosis
(Annexure
3).
VI. Twocopiesofreport(Annexure4)willbesenttothereferringARTcenter(bothhard&softcopy)within 4 weeks
VII. CopyofthereporttoberetainedbythereferringARTcenter&originaltobehandedovertopatient/client
InstructionstobefollowedatHIV2ReferralLaboratories:
I. CheckICTCreport,ReferralslipfromARTcenter,photoIDandrelateddetailsintheformsII. Collect5mlbloodeachintwotubes oneplainandoneEDTAvacutainertubeIII. Separatetheserumfrombloodcollectedinplainvacutainer.Proceedasperthealgorithm
forHIV2asperAnnexure3
IV. StorethebloodcollectedinEDTAvacutainerat200C.OnlythosesampleswillbesendtoApexlaboratorywhoseresultisindeterminateeitherforHIV1,HIV2 orHIV1&2by
Westernblot(Annexure5:PCRrequisitionform).ThesesampleswillbetestedatApex
laboratorybyMoleculartests.
V. ReportstobesenttoreferringARTcenterbybothassoftcopy(e mail)andahardcopy.Hardcopyofthereporttobepreparedintriplicate.Originalandacopytobesenttothe
referringARTcentreandonecopytoberetainedintheReferrallabforrecords.
VI. UtilizationofkitdetailstobesubmittedtoApexlaboratoryeveryquarterlyasperAnnexure6
8/12/2019 Operational Guideline for HIV 2 Diagnosis
3/14
FlowchartForreferringthePatientforHIV2Testing
Clients/Patients
(withICTC
Report
Specimen
is
positive
for
HIV
antibodies
(HIV
1and
HIV
2;
or
HIV
2alone)
andReferralslip]
ARTCenter
DesignatedHIV2referrallaboratory
Collectfresh
blood
specimen
TestasperthenationalalgorithmforHIV2serodiagnosis
ReportingtoreferringARTcenter(bothhard&softcopy)
RetainacopyofreportatARTandhandoveroriginalreporttopatient
8/12/2019 Operational Guideline for HIV 2 Diagnosis
4/14
Annexure1:DesignatedHIV2referrallaboratories
Sr.No. ReferringARTcenters Nameoflaboratory ContactName&Address
1 Maharashtra,Mumbai,
Dadra&NagarHaveli,
Daman&
Diu,
Goa
NARI,Pune Dr.A.R.Risbud
ScientistF
NationalAIDS
Research
Institute
NACOlaboratory
PlotNo.73,GBlock,MIDC,
Bhosari,Pune411026
Ph.No:02027331200Ext.
Email:[email protected]
2 Bihar,WestBengal,
Jharkhand,Sikkim,
SchoolofTropical
Medicine(STM),
Kolkata
Dr.BhaswatiBandopadhyay
NRLIncharge
Dept.ofVirology,4th
Floor,
SchoolofTropicalmedicine,108,C.R.Avenue
Kolkata700073.
Ph.No:03322198538
Email:[email protected]
3 Delhi,Haryana,Himachal
Pradesh,Jammu
&Kashmir,Punjab,
Chandigarh,Rajasthan
NationalCentrefor
DiseaseControl
(NCDC), Delhi
Dr.R.L.Icchpujani
NRL Incharge, Centre of AIDS & Related
Diseases, NationalCentreforDiseaseControl,
22 ShamnathMarg,NewDelhi110054.
Tele/Fax:011 23934517
Email:[email protected]
4 AndhraPradesh IIPM,Hyderabad Dr.UmaDevi
NRL
In
charge
InstituteofPreventiveMedicine,
BSQCDepartment,Narayanguda, NearYMCA
Hyderabad500029
Ph.No:04027568167
Email:[email protected]
5 UttarPradeshand
Uttaranchal
NIB,Noida Dr. RebaChabra
NRLIncharge
NationalInstituteofBiologicals
A32,Sec 62,NOIDA(UP)201307
Ph.No:01202400022/2400072
Ext.2380/2173
Email:[email protected]
6 Assam,Meghalaya,
ArunachalPradesh
Guwahati Medical
College&Hospital
Dr.NabaKr.Hazarika
Dept.ofMicrobiology,
GauhatiMedicalCollege&Hospital,
Guwahati781032
Ph.No:03612529457
Email:[email protected]
8/12/2019 Operational Guideline for HIV 2 Diagnosis
5/14
7 Odisha SCBMedicalCollege&
Hospital,Cuttack
Dr.AshokaMahapatra
SCBMedicalCollege&Hospital,
Cuttack,Orissa751007
Ph.No:06712410041
Email:[email protected]
8 Gujarat BJMedicalCollege,
Ahmedabad
Dr.M.M.Vegad
Head&Prof.Dept.ofMicrobiology,
B.J.MedicalCollege,Asarwa,
Ahmedabad,Gujarat380016
Ph.No:07922683721
Email:[email protected]
9 Kerala,Lakshwadweep TD medical college,
Alapuzha
Dr.AnithaMadhavan
SRL,DepartmentofMicrobiology.
Govt.TDmedicalcollege,
Alapuzha,Kerala
688005
Ph.No:04772282015
Email:[email protected]
10 Madhya Pradesh &
Chattisgarh
Gandhi Medical
College,Bhopal
Dr.DeepakDube
SRLIncharge,DepartmentofMicrobiology,
GandhiMedicalCollege,
BarakktullahVishwavidyalaya,
SultaniaRoad,Bhopal 462001.
Ph.No:07552730502
Email:[email protected]
11
Karnataka
NIMHANS,Bangalore
Dr.
Anita
Desai
AssistantProfessor
Dept.ofNeurovirology,NIMHANS,
HosurRoad,Bangalore560029.
Ph.No:08026995778Ext.
Fax:08026564830
Email:[email protected]
12 Manipur,Nagaland,
Tripura,Mizoram
RIMS,Imphal Dr.Ng.BrajachandSingh
NRLIncharge
DepartmentofMicrobiology,
RegionalInstituteofMedicalScience,P.O.
Lamphelpat,Imphal
(west),
Manipur
795004
Ph.No:03842414750 Ext181
Email:[email protected]
13 TamilNadu&
Pondicherry,Andaman&
Nicobarislands
MadrasMedical
College,Chennai
Dr. Vasanthi
Prof&OfficeIncharge, HIVNRLLaboratory,
TowerBlock1,RoomNo.106,
MadrasMedicalCollege,Chennai600003
Ph.No:04425383445Ext.
Email:[email protected]
8/12/2019 Operational Guideline for HIV 2 Diagnosis
6/14
Annexure2:ReferralSlipforHIV2testing
TobefilledinduplicatebyARTI/C/SMO/MO.Originalcopytobesentto
HIV2referrallaboratoryClient/patienttocarryICTCHIVreport&photoID
Name: Surname___________Middlename ____________ Firstname___________________
Date:_________________(DD/MM/YY) Gender: M/ F/TG Age:_________Years
ICTCPID
#___________
Pre
ART
Reg.
no.
______________
NameandpostaladdressofreferringARTcenter:
EmailIDofreferringARTcenter/MOincharge:
Name&SignatureofMedicalOfficerARTcenter:
8/12/2019 Operational Guideline for HIV 2 Diagnosis
7/14
Annexure 3: National HIV 2 Testing Algori thm
TestKitstobeusedatthereferrallab:
Rapid1:DetermineHIV1/2(FDAApproved) HIV1WesternBlot: NewLAVBlot1
Rapid2:
HIV
Tridot
HIV
2
Western
Blot
:New
LAV
Blot
2
Rapid3:ImmunocombBispotHIV1&2
TestingAlgorithmforHIV2samples
S.NO.
T1 T2 T3
ActionrequiredResults WB
HIV1
Result
WBHIVDETERMINE HIVTRIDOT IMMNOCOMB
SCREENING HIV1 HIV2 HIV1 HIV2
1 NEG FollowupwithICTC
throSRL
2
POS
TESTBYBOTH
HIVTRIDOT
AND
IMMUNOCOMB
POS NEG POS NEG
Nofurthertesting
requiredasboth
differntiatingrapid
testsaregivingHIV1
result
8/12/2019 Operational Guideline for HIV 2 Diagnosis
8/14
3 POS POS POS POS POS
PerformHIV1&HIV2
WB(ToconfirmHIV
type)
POS NEG
NEG POS
POS POS
NEG NEG
POS IND
IND POS
IND IND
4 POS NEG POS NEG POSPerformHIV2WB(To
confirmHIV2status)
NEG
POS
IND
5 POS POS NEG NEG POS
PerformHIV1&HIV2
WB(ToconfirmHIV
type)
POS NEG
NEG POS
POS POS
NEG NEG
POS IND
IND
POS
IND IND
8/12/2019 Operational Guideline for HIV 2 Diagnosis
9/14
8/12/2019 Operational Guideline for HIV 2 Diagnosis
10/14
Annexure4:ReportFormattobeusedbyHIV2ReferralLaboratories
Tobefilledintriplicate.TwocopiestobesendtoreferringARTcenter
(oneforPatientandoneARTrecord)
NameoftheReferralLaboratory
Name:Surname___________Middlename ____________Firstname____________________
Date:_________________(DD/MM/YY) Gender: M/ F/TG Age:_________Years
ICTCPID# ___________ PreARTReg.no.______________
LaboratorySampleID___________________
NameofreferringARTcenter:
Dateofsamplecollection(DD/MM/YY)
Date
of
sample
testing
(DD/MM/YY)
TestNameRapid1
Rapid
2
Rapid
3HIV1WB HIV2WB
Nameofthekit
Result
FinalInterpretationofTestResult:
SignatureoflaboratoryIncharge Date:
POS:Positive, Neg:Negative,IND:Indeterminate,ND:NotDone,WB:WesternBlot
***ENDOFREPORT***
8/12/2019 Operational Guideline for HIV 2 Diagnosis
11/14
Annexure5:PCRRequisitionForm
NameoftheReferralLaboratoryrequestingPCR:
Name: Surname___________Middlename ____________Firstname____________________
Dateofsamplecollection:_________(DD/MM/YY)Gender: M/ F/TG Age:_________Years
ICTCPID# ___________ PreARTReg.no.______________
LaboratorySampleID___________________
NameofreferringARTcenter:
Address
of
referring
ART
center:
Serologicaltestresultatthereferrallaboratory:
SignatureoflaboratoryIncharge:
8/12/2019 Operational Guideline for HIV 2 Diagnosis
12/14
Annexure6:Inventoryforkitutilization
(TobesentquarterlytoApexlaboratorybyemail)
Date:
Nameofkit BatchNo./
Expirydate
No.ofkits
received
No.ofkits
used
Balance
DetermineTM
HIV1/2
HIVTridot
ImmunocombBispot
HIV1/HIV2
NewLav
Blot1
NewLavBlot2
SignatureofLaboratoryIncharge:
8/12/2019 Operational Guideline for HIV 2 Diagnosis
13/14
Annexure7: HIV2ReferralLaboratoryCumulativeMonthlyReportingFormat
NameofHIV2ReferralLaboratory:
HIV2ReferralLaboratorycumulativeMonthlyReportingFormat
Month/Year
Number
ofART
centers
referring
patients
Number
of
patients
received
Number
of
primary
samples
collected
Number
thatare
only
HIV1
Positive
Number
thatare
only
HIV2
Positive
Number
thatare
both
HIV1&
HIV2
Positive
Number
thatare
referred
toApex
labfor
further
testing
Number
thatare
HIV
Negative
Number
of
samples
thatare
rejected
SignatureofLaboratoryIncharge:
8/12/2019 Operational Guideline for HIV 2 Diagnosis
14/14
Annexure8:ICTCHIVTestReportingFormat
HIVTESTREPORTFORMNameandaddressofICTCcentre: (Formtobefilledinduplicate)
Name:Surname___________ Middlename____________ Firstname ____________________
Gender: M/ F/TG Age:_________Years PID# ___________ LabID#_____________
Dateandtimeblooddrawn:____________________(DD/MM/YY) ________________________(HH:MM)
TestDetails:
Specimentype
used
for
testing:
Serum
/Plasma
/Whole
Blood
Dateandtimespecimentested: ___________(DD/MM/YY) ___________(HH:MM)
Note:
Column2and3tobefilledonlywhenHIV1&2antibodydiscriminatorytest(s)used Nocellhastobeleftblank;indicateasNAwherenotapplicable.
Column1 Column2 Column3 Column4
NameofHIVtestkit
Reactive/Nonreactive(R
/NR) for HIV1
antibodies
Reactive/Nonreactive
(R/NR) for HIV2
antibodies
Reactive/Nonreactive
(R/NR) forHIVantibodies
TestI:
TestII:
TestIII:
Interpretationoftheresult: Tick()relevant
Specimenisnegative forHIVantibodies
SpecimenispositiveforHIV1antibodies
*SpecimenispositiveforHIVantibodies(HIV1andHIV2;orHIV2alone)
Specimen
is
indeterminate
for
HIV
antibodies.
Collect
fresh
sample
in
two
weeks.
*ConfirmationofHIV2sero statusatidentifiedreferrallaboratorythroughARTcentres
Name&Signature Name&Signature
LaboratoryTechnician LaboratoryIncharge
Endofreport