Malawi Integrated HIV,

Syphilis and Hepatitis B

Rapid Testing

Testing Algorithms: HIV,

Syphilis & HBsAg
 Learning Objectives
By the end of this session, participants should
be able to:
 Define the term algorithm.

 Demonstrate how to determine HIV,

Hepatitis B, Syphilis status based on
approved algorithm.
 Explain how to correctly determine HIV
status in a variety of testing scenarios
Rapid Testing Algorithm
 An algorithm is a sequence of steps to
follow to establish a person’s status.
 Currently Malawi uses 3 different tests,
performed in serial (Sequence) for HIV

Always follow the sequence of the tests

as defined in the algorithm
 3 Test Algorithm

 Positive HIV status is determined when all the 3

tests are reactive
 If test 1 is non reactive the HIV status is negative
 If test 1 is reactive and test 2 non reactive repeat
test 1 same visit.
 If test 1 is non reactive, the HIV status is
negative
 If it is reactive, the outcome is inconclusive
 If test 1 is reactive, test 2 is reactive but test 3 is
non reactive the outcome is inconclusive 4
 National Testing Algorithms
Importance of using National Testing
Algorithm
 Country-wide standardization

 Simplified procurement
 Simplified supply management
 Uniform training
 Quality monitoring
HIV Test Performance

 No test is 100 % accurate

 Always follow sequence of tests in the
algorithm
 A combination of results (an algorithm) is
essential to diagnose HIV infection
Malawi HIV Testing Algorithm(1)

Determine (T1)
Reactive Non-reactive
High risk event
in last 72hrs:
Uni-Gold (T2) PEP

Ongoing high-
Reactive Non-reactive risk: PrEP,
VMMC, etc

Bioline HIV (T3) Repeat Test 1- Same visit

Reactive Non-reactive
Repeat whole 3 test algorithm after
2 weeks, If repeat still inconclusive:
DBS for reference lab

Start ART as soon as

client is ready
(Within 2 weeks)
Malawi HIV Testing Algorithm(2)
Unigold (T2): Non-Reactive
Repeat Test 1-same visit

Determine (T1)

Reactive Non-reactive

Repeat whole 3
test algorithm High risk event in last
after 2 weeks, If HIV Inconclusive Negative 72hrs: PEP
repeat still
Ongoing high-risk:
inconclusive:
PrEP, VMMC, etc
DBS for
reference lab
Malawi HIV Testing Algorithm(3)
Determine (T1) Reactive

Blood sample
Uni-Gold (T2) Sedia Asante (RTRI)

Long term Recent Negative

infection

Bioline
Non-Reactive DBS for VL
Reactive HIV (T3)
<1000 1000+

Long term Recent

Infection Infection
Repeat Test 1- Same visit
….See testing algorithm 2
Malawi HIV Testing Algorithm(4)
HIV Testing Client Flow in Registers
 2023 Malawi HIV, Syphilis and Hepatitis B Integrated Rapid Testing and Counselling Guidelines

HIV Testing Client Flow in the 2023 Registers 2023 HIV Diagnostic Algorithm for: Never tested, Last self-test (neg, pos, inc), Last professional test (neg, inc, exp infant) 2023 HIV Diagnostic Algorithm for Last Professional Positive Clients
Has the client ever been tested for HIV? If yes, was the most recent test:
Diagnostic Algorithm Recency Surveillance * Diagnostic Algorithm
 Self-test or professional test? Documented results are preferred, but reported results are acceptable.

Blood Draw 1
Blood Draw 1
* Syphilis and hepatitis B tests are done in parallel with
 Document previous test status in Initial Testing Register.
 Regardless of previous test status: all clients follow the full serial 3-test algorithm HIV test 1 in certain entry points. Recency testing is only
Syphilis done in selected facilities
HIV Test 1 HIV Test 1
Hepatitis B * R = reactive
LT = long-term
Rec = recent R = reactive
Most recent: Most recent: NR R NR= non-reactive NR R
Never tested Neg = negative NR= non-reactive
Self-test Professional test
I n f or me d Co ns e nt

Blood Draw 2
Blood Draw 2
Negative, Initial positive*, New Recency
HIV Test 2 HIV Test 2
Negative, Positive or Invalid
Positive, New inconclusive, Test
Exposed infant, Positive or NR R LT Neg NR R
Inconclusive re-test Rec

Blood Draw 3
Blood Draw 3
Initial Register
HIV Test 1 HIV Test 1 HIV Test 3 DBS for VL HIV Test 1 HIV Test 3
* Initial Positive: Clients with a
NR R NR R <
positive HIV test 1 result 1000 1000 NR R NR R
(entered in the Initial Testing +

Interpretation

Interpre tation
HIV Test 1 positive Register) who did not complete
͞Initial positive͟Ύ the full 3-test algorithm Long-term Recent
(confirmatory testing). This may Negative Inconclusive Positive (Ignore) Negative Inconclusive Positive
Infection Infection
happen with community-based
testing.
Confirmatory Register
HIV Test 2, 3, 1, Recency

Result Given

Result Given
New New Positive Inconclusive Positive
Negative None
Inconclusive or Exp. Infant Re-test Re-test
New inconclusive, New positive, Patients on ART
HIV negative
Inconcl. re-test Positive re-test (once per year)
Repeat whole 3- Start ART as soon Continue / start ART as soon as client is ready
 High risk event in last 72hrs: PEP, re- (No routine follow-up) Repeat whole 3-test algorithm after 2 weeks
test algorithm as client is ready (within 2 weeks). HIV exposed infant if client is <12

Referral

Referral
test after 4 weeks If repeat is still inconclusive: DBS for reference lab
after 2 weeks (within 2 weeks) months. All children under 24 months who start or
** Self- tests may be  Ongoing risk: re-test after 12 months DBS result provides final diagnosis, except:
Send DBS to Ref. If repeat is still HIV exposed *All children under 24 months who start or re-start ART re-start ART need a confirmatory DNA-PCR using a
distributed for use by  Client on PrEP: re-test 3-monthly If DBS is negative and client is on ART: interrupt ART, repeat
Lab if repeat Index register inconclusive: DBS infant if client is need a confirmatory DNA-PCR using a new DBS sample. new DBS sample. This should be collected on the
partners or others, regardless  Refer high-risk for VMMC, PrEP, etc. 3-test algorithm after 3 months.
inconclusive for reference lab <12 months* This should be collected on the day of starting ART. day of starting ART.
of the recipients own HIV
status. However, never give
self-tests for self-use by
clients with a previous
positive or inconclusive test Contact Register
result.
Syphilis Screening Hepatitis B (surface antigen) screening
2023 Diagnostic Algorithm 2023 Diagnostic Algorithm
Self-test Distribution
Register**

Need for HBV

syphilis te st
Need for

test
Not eligible Eligible* Not eligible Eligible*

HIV Risk Assessment

Syphilis test

HBV test
Hepatitis B surface
Syphilis Rapid Test
antigen rapid test
Low risk Ongoing risk High risk
(moderate)
 No sex / abstinence  Any of the 6 substantial risk factors defining PrEP need, but client is NR R NR R
 Consistent and correct  Stable partner with not, or not consistently, using PrEP:

HBV infection
Ask: previous
treatment?

condom use with all unknown HIV 1. Current or recent STI: in last 6 months, self-report or clinical
Treated for syphilis Never treated for

risk
partners status without diagnosis Low High*
in the past syphilis before
 Consistent PrEP use* (any other high-risk 2. Transactional sex: paid or received money or goods for
partners) sexual partners condomless sex (incl. sex workers and clients)
 Stable known HIV  Born / breast 3. Condomless sex with a known HIV infected regular partner who is
negative partner who feeding from HIV not on ART or with viraemia 1000+ on their most recent VL result
Refer to lab for

HIV status***
confirmation

does not engage in risky infected mother on 4. Condomless sex with regular partner with unknown HIV status Lab tests for active Lab tests not
behaviour ART who has other high-risk sexual partners. infection** available*** HIV negative or
inconclusive HIV positive
 Stable HIV infected 5. Condomless anal intercourse with non-regular partner NR R
partner who is taking ART 6. Injecting drug use with needle sharing
with viral load <1000  Rape (regardless of HIV status of perpetrator)
copies/ml on their most  Condomless sex with non-regular partner (known pos. or unknown
Other tests and re- Full course of 3 Enroll in HBV clinic
recent result. HIV status) No syphilis treatment. Enroll in HBV clinic
test appointment HBV vaccinations for reporting.
Referral

Referral
 Occupational exposure: needle stick injury, etc. Other tests and re-test for diagnostic
Treat for Syphilis based on risk (unless already Start or continue
 Born / breastfeeding from HIV infected mother not on ART appointment based on risk follow-up /
assessment and completed in the ART for HIV and
assessment and guidelines treatment
HBV
guidelines past)
*Consistent PrEP use means taking oral or injectable PrEP exactly as prescribed for the minimum required time before and after all risky acts (see PrEP guidelines)
* Eligibility for HBV testing: see Table 5 in Integrated Testing Guidelines for who and when to test for Hepatitis B.
* Eligibility for syphilis testing: see Table 5 in Integrated Testing Guidelines for who and when to test for syphilis.
** Table 5 shows high risk groups who should be referred for a course of 3 HBV vaccinations unless they have
But: condomless sex carries high risk of unwanted pregnancy ** Lab test for active infection: Clients with a previous syphilis infection usually have a positive rapid test for life, even previously completed 3 HBV vaccinations: FSW, TG, MSW, MSM, PWID, prisoners, PrEP clients, children 0-14 years born
ART and PrEP are and STIs if the infection was cured. Additional lab tests (RPR or VDRL) are needed to confirm a new, active syphilis infection. to HBV positive women, STI patients, general population at ongoing HIV risk or after high-risk event, health workers,

 !
very effective  Some STIs can not be cured and may cause ugly sores on *** Lab tests not available: Lab tests for confirmation of active syphilis infection may not be available at all sites. In sex partners of HBV index clients, sex partners of STI patients, presumed hepatitis patients, in-patients.
HIV prevention genitals, long-term suffering, cancer and death (hepatitis this case, refer for presumptive syphilis treatment to ensure that any potentially new syphilis infection is treated. *** HIV status must be ascertained for all HBV positive clients. Perform a new HIV test using the full 3-test algorithm
methods if used B, herpes simplex, HPV, HTLV) unless the client is already known to be HIV positive.
consistently  Even curable STIs are often missed, causing infertility,
stillbirth, nerve and brain damage, etc.
 Discordant Test Results
What to do if Tests are Discordant
 If there are discordant test results, the final result
given to the client is inconclusive
 When client returns after 2 weeks, conduct the 3 test
algorithm in serial
 If the result is still inconclusive, prepare a DBS
specimen and send to reference lab
 Give client a date to return and receive DBS results
which should be ready after 4 weeks
 Take client’s phone number or address and contact
the client when results are ready
Invalid HIV test result
 A blank test or a test filled with red means
the test did not work well and is “invalid”
 This means it will not tell you if you have HIV or
not
 You need to repeat with a new Self testing device
or go to any HTS site for testing
 Do not re-use the same device

16
Further Interpretation for Uni-Gold
 Grey Lines:
 do not indicate the presence of antibodies to HIV;
always interpreted as non-reactive.
 Broken Lines
 Test Line: Broken pink/red test line is deemed initially reactive
on the presence of a control line
 but the sample must be repeated in duplicate (use 2 devices at once)
 Control Line: A broken pink/red control line does not affect
the validity of the test.
 Whole Blood Migration
 Presence of whole blood sample in the device window does not
affect the result if there is no obstruction in the test line region at
10 to 12 minutes.
 If the sample infringes on the test line region, the test is invalid and should be17
repeated.
Testing Algorithm: Example 1
Test 1 Test 2 & 3 HIV status

No 2nd & 3rd test

because
initial test was
HIV negative
non-reactive
 Testing Algorithm: Example 3
Test 1 Repeat Test 1 Test 2 & 3rd HIV status

No 2nd & 3rd

test
is needed HIV negative
because
repeat test
was valid and
non-reactive
Testing Algorithm: Example 2
Test 1 Test 2 Test 3 HIV status

123 123 HIV positive

20
Testing Algorithm: Example 4
Test 1 Repeat Test 1 HIV status
Test 2
Same visit
123
123 123 HIV Inconclusive

Repeat whole 3 test algorithm

after 2 weeks, If repeat still
inconclusive: DBS for reference
lab

21
Testing Algorithm: Example 4
Test 1 Repeat Test 1 HIV status
Test 2
Same visit
123
123
123 HIV Negative

22
Testing Algorithm: Example 5
Test 1 Test 2 Test 3 HIV status

123 123 HIV Inconclusive

Ask the client

to return after
2 weeks for
retesting

23
HIV Oraquick – reading results

POSITIVE NEGATIVE INVALID

Testing Algorithm: Recency -
Example 6

Recency Test Recency Status

or or
Invalid

• No need of repeating
if testing client
sample
• Repeat if testing QCs
25
 Testing Algorithm: Recency -
Example 7

Recency Test Recency Status

HIV Positive and Recent

• Collect a DBS
for confirmation

26
 Testing Algorithm: Recency -
Example 8

Recency Test Recency Status

HIV Positive and Long term

• No need of
collecting DBS
27
HIV Repeat Testing and
Retesting Guidelines
 Repeat Testing vs. Retesting
Term Definition
Repeat • Conduct same test a second time during
testing same visit
• Occurs when:
• 1st test is invalid or
• 1st and 2nd tests are discordant
Retesting • Client is asked to come back after a
specified period of time to be tested again
• Occurs when:
• Inconclusive test result is given
• Risk behaviour suggests testing again
is needed
Retesting Recommendations (1)
 When the client has inconclusive results:
 Retest after 2 weeks

 HIV negative with specific risks:

Risk Category Advise to:

Pregnant woman Retest in 3rd trimester and before

discharge after delivery
High Risk Event in last 3 months Retest in 4 weeks--rule out new
infection
STI patients Retest after 4 weeks and with every
new episode of STI
HIV negative person with ongoing Retest annually
risk
High risk event within last 72 Provide PEP as per guidelines
hours Retest after 4 weeks
Retesting Recommendations(2)
Risk Category Advise to:

Breastfeeding women Re-test at 6 or 9 months

with negative HIV test in FP/EPI. Subsequent
at delivery retesting will depend on
risk assessment.
PrEP clients Every 3 months

People in prisons Re-test according to risk

assessment
HBsAg & Syphilis Diagnostic
Flowcharts
Malawi Hepatitis B Algorithm
Malawi Syphilis Testing Algorithm-
RDT
 Key Points
 An algorithm is a sequence of steps to follow to establish
a person’s status
 The national HIV testing algorithm in Malawi is serial, in which:
 Determine HIV-1/2 is test 1
 UniGold HIV-1/2 is test 2 and
 Bioline HIV-1/2 is test 3
 An HIV positive status must be based on three reactive tests—
Determine, Unigold and Bioline HIV
 Retesting recommendations are based on risk
 Syphilis and Hepatitis B tests in Malawi are done using
 Determine Syphilis Rapid Test
 Determine™
HBsAg