operational guideline for hiv 2 diagnosis

8/12/2019 Operational Guideline for HIV 2 Diagnosis

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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


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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


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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


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


4 AndhraPradesh IIPM,Hyderabad Dr.UmaDevi

NRL

In

charge

InstituteofPreventiveMedicine,

BSQCDepartment,Narayanguda, NearYMCA

Hyderabad500029

Ph.No:04027568167


5 UttarPradeshand

Uttaranchal

NIB,Noida Dr. RebaChabra

NRLIncharge

NationalInstituteofBiologicals

A32,Sec 62,NOIDA(UP)201307

Ph.No:01202400022/2400072

Ext.2380/2173


6 Assam,Meghalaya,

ArunachalPradesh

Guwahati Medical

College&Hospital

Dr.NabaKr.Hazarika

Dept.ofMicrobiology,

GauhatiMedicalCollege&Hospital,

Guwahati781032

Ph.No:03612529457



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7 Odisha SCBMedicalCollege&

Hospital,Cuttack

Dr.AshokaMahapatra

SCBMedicalCollege&Hospital,

Cuttack,Orissa751007

Ph.No:06712410041


8 Gujarat BJMedicalCollege,

Ahmedabad

Dr.M.M.Vegad

Head&Prof.Dept.ofMicrobiology,

B.J.MedicalCollege,Asarwa,

Ahmedabad,Gujarat380016

Ph.No:07922683721


9 Kerala,Lakshwadweep TD medical college,

Alapuzha

Dr.AnithaMadhavan

SRL,DepartmentofMicrobiology.

Govt.TDmedicalcollege,

Alapuzha,Kerala

688005

Ph.No:04772282015


10 Madhya Pradesh &

Chattisgarh

Gandhi Medical

College,Bhopal

Dr.DeepakDube

SRLIncharge,DepartmentofMicrobiology,

GandhiMedicalCollege,

BarakktullahVishwavidyalaya,

SultaniaRoad,Bhopal 462001.

Ph.No:07552730502


11

Karnataka

NIMHANS,Bangalore

Dr.

Anita

Desai

AssistantProfessor

Dept.ofNeurovirology,NIMHANS,

HosurRoad,Bangalore560029.

Ph.No:08026995778Ext.

Fax:08026564830


12 Manipur,Nagaland,

Tripura,Mizoram

RIMS,Imphal Dr.Ng.BrajachandSingh

NRLIncharge

DepartmentofMicrobiology,

RegionalInstituteofMedicalScience,P.O.

Lamphelpat,Imphal

(west),

Manipur

795004

Ph.No:03842414750 Ext181


13 TamilNadu&

Pondicherry,Andaman&

Nicobarislands

MadrasMedical

College,Chennai

Dr. Vasanthi

Prof&OfficeIncharge, HIVNRLLaboratory,

TowerBlock1,RoomNo.106,

MadrasMedicalCollege,Chennai600003

Ph.No:04425383445Ext.



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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:


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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


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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


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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***


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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:


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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:


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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:


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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

operational guideline for hiv 2 diagnosis

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