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Interpretasi Hasil Pemeriksaan

Laboratorium HIV

Agnes R. Indrati
Divisi Imunoserologi
Dept. Patologi Klinik
FK Universitas Padjadjaran/ RS Hasan Sadikin

Mr. X, 37 tahun.
Hasil pemeriksaan anti HIV Januari 2017:
Non reaktif dengan pemeriksaan anti HIV rapid test
reagen A
Anti HIV reagen A Sensitivitas 99%, spesifisitas 100%
Karena risiko tinggi (pemakai narkoba suntik sejak 7
tahun lalu), pemeriksaan anti HIV diminta diulang.
Pemeriksaan ulang dilakukan 3 bulan (April 2017)
kemudian dengan hasil sebagai berikut
Kasus (lanjutan)

Pemeriksaan metode Nama sensitivitas Spesifisitas Deteksi Hasil

I rapid A 99% 100% Ab & Reaktif
Ag p24
II rapid B 99% 99% Ab gp 140 Non
III rapid C 100% 98% Ab p24 Reaktif

Kesimpulan : Inkonklusif

Hasil pemeriksaan pertama dan kedua

berbeda (negative dan inkonklusif)
Hasil pemeriksaan kedua inkonklusif
Bagaimana menyikapi hasil pemeriksaan
Bagaimana urutan reagen pada tes HIV

Generasi pemeriksaan HIV + Antigen

Window period
Sensitivitas spesifisitas
Algoritme HIV terbaru
Tes konfirmatori
Pemeriksaan ulangan (retest)
HIV in Indonesia
HIV AIDS Situation in Indonesia

90-90-90 Target cascade



300000 39.9%

Estimated Knew their On treatment Virally
number of HIV status suppresed ?

(Kemenkes RI, Maret 2017)

key strategies for effective
HIV management

Early HIV ART Early Infant

Diagnosis Monitoring Diagnostic

ART Oportunistic
Initiation Infection
HIV serological assays
Window Period based on tests method
Performance Characteristic of HIV tests
HIV Test Algorithm in Indonesia

WHO recommendations retesting is warranted for the following

1. Individuals testing HIV-negative who:
 have ongoing risk for HIV infection
 pregnant, in high HIV prevalence settings; HIV-negative in the first
2. Individuals whose HIV status is inconclusive
 return in 14 days for additional testing to confirm their diagnosis
3. Individuals diagnosed HIV-positive
 should be retested to verify their HIV
 Retesting is not recommended for individuals on ART

Source: WHO, 2010 (12, 57) ; WHO, 2014 (12, 57)

Confirmatory testing

The HIV-1 Western blot and HIV-1 IFA  no longer part of the
recommended algorithm:
 false-negative or indeterminate results early in the course of HIV
 majority of HIV-2 infections misclassified as HIV-1 by the HIV-1
Western blot
 HIV-1 NAT confirmation
 additional laboratory tests (HIV-1 VL & CD4):
to confirm the presence of HIV-1 infection
to stage HIV disease
to assist in the selection of an initial ART
Confirmatory testing

Pemeriksaan virologis digunakan untuk mendiagnosis HIV

 bayi berusia dibawah 18 bulan.
 infeksi HIV primer.
 kasus terminal dengan hasil pemeriksaan antibodi negative namun gejala
klinis sangat mendukung ke arah AIDS.
 konfirmasi hasil inkonklusif atau konfirmasi untuk dua hasil laboratorium
yang berbeda.

PNPK 2019
Common causes of false results in HIV
serological assays
Common causes of false results in HIV
serological assays
Kasus (lanjutan)

 Hasil pemeriksaan follow up:

Jenis Pemeriksaan Januari 2018 Juli 2018 Satuan Nilai normal
Jumlah CD4 25 44 Sel/µL 410 - 1590
% 31 - 60
Viral Load 427505 124407 Copies/mL Virus terdeteksi:
Log 5,63 Log 5,09 • <40 (copies/ml)/
<1,60 Log
• 1,6-7,0 Log
• >7.0 Log

 Adherens kurang baik


Kenapa CD4 turun walaupun VL turun

Kapan kita harus periksa CD4 dan VL
Apakah harus memeriksakan CD4 kalau sudah
periksa VL
Perubahan/ dinamika CD4 dan VL pada
perjalanan penyakit
Kegagalan terapi
Metode pemeriksaan CD4, limit deteksi
Metode pemeriksaan VL, limit deteksi
Immunological and virological events
in natural course of HIV infection
Clinical, Immunological
& Virological failure
CD4 Evaluation


• staging & monitoring HIV patients

• initiation ART
• prophylactic therapy

POC CD4 T-cell counting devices

• compact, portable and use disposable cartridges
• venous and capillary blood
• Multiple internal quality control

Parekh et al. cmr.asm. January 2019, 32, 1.e00064-18


•well-trained •improve

Flowcy tometry
laboratory access,
technicians especially for
•good sample rural patients
transport • to reduce
systems patient loss to

Parekh et al. cmr.asm. January 2019, 32, 1.e00064-18

Point-Of-Care CD4 Counting Reduces
Pre-Treatment Loss-To-Follow-Up
Percent Of Patients Receiving Percent Of Patients Returning
CD4 Test Results After Initial CD4

Source: Jani et al. AIDS (2011)

Viral Load

 a nucleic-acid-based test
 monitor response to treatment, disease
progression & predict outcome
 access is very limited in RLS
 done in centralized facilities, expensive
instrumentation, technical skill
 high costs per assay


Viral Load to HIV management

• need to scale up
• the most effective method to
VL testing evaluate the response of ART

• improve access to VL testing

• improve patient care
testing management

Brook G. BMJ. Sex Transm Infect. 2018


benefit limitation
the cost per test is similar
relatively easy to use to most other
commercial VL assays

requires a relatively
already being used for
sophisticated laboratory
TB diagnosis

plasma samples ,
requires additional time
and resources
Correlation lab based vs POCT VL

 monitoring ART treatment

failure (>1000 copies/mL)
 Xpert system vs laboratory HIV
VL with plasma samples:
 98% concordance
 94% sensitivity
 99% specificity

Kulkarni et al. BMC Infect Dis. 2017; 17: 506 Brook G. BMJ. Sex Transm Infect. 2018
Kasus (lanjutan)

Istri mrs. Y hamil dan pada ANC trimester pertama

disarankan memeriksakan anti HIV.
Hasil Pemeriksaan mrs. Y:
 Anti HIV reaktif (3 metode dengan rapid)
 CD4 : 514 sel/µL
 VL : not detected
Melahirkan dengan cara spontan, menyusui dengan ASI
Hasil pemeriksaan bayi pada usia 2 bulan (8 minggu)
 Anti HIV (+)
 HIV DNA (+)
 Bagaimana pemeriksaan anti HIV pada ibu hamil?
 Apa interpretasi anti HIV pada bayi?
 Apakah perlu pemeriksaan HIV DNA? Bisakah VL
digunakan untuk diagnosis?
 Pemeriksaan HIV utk ibu hamil
 Algoritme pemeriksaan pada bayi/ anak <18 bulan
 Metode pemeriksaan PCR DNA
 Sampel Dried Blood Spot (DBS)
Algoritme Pemeriksaan HIV pada
bayi dan anak <18 bulan
Early Infant Diagnosis

 The WHO & UNICEF recommended virological testing for

infant HIV diagnosis (< 18 m of age)
 Quantitative viral RNA or qualitative proviral DNA
 Minimum sensitivity of 95% (preferably 98%) & specificity
of 99%.
 Virological testing for HIV-exposed infants at 4-6 weeks
of age or at the earliest opportunity thereafter
Early Infant Diagnosis

 The most widely-used test for EID is a DNA PCR molecular

test, which is also performed on sophisticated
laboratory-based instruments.
 HIV-1 DNA test detects HIV proviral DNA
 Alternatively the RNA PCR quantitative tests/ viral load
 Dried blood spot
Dried Blood Spot

 Greater stability than fresh whole blood / plasma

 Simplifies samples transport
 Cost effective.
expand testing access into peri-urban & rural settings

Murtagh et al. ASLM (2013)

Usage of DBS in HIV Virology

• easily obtained, stored, & training required is less
• more stable over longer periods
• DBS are more easily transported

• reduced sensitivity of viral RNA amplification
• in low viral loads, genotyping results is not accurate
• challenges surrounding the pre-extraction and
analytical stages need to be resolved
VL Comparison from Plasma & DBS
in Asia & Africa

Monleau et al. JCM