Caracteristicas carga viral

ANNEX 1B

Summary of main characteristics of viral load technologies

NUCLEIC ACID BASED
COMPANY ROCHE ROCHE ROCHE ROCHE

Assay Name

AMPLICORTM HIV-1 Monitor® Test v1.5 RT-PCR, quantitativeCOBAS AMPLICORTM HIV-1 Monitor® Test v1.5 RT-PCR, quantitative

TaqMan HIV-1 Monitor Test v1.5 Real-Time RT-PCR, quantitative 40–10 Million copies/ml (95% confidence) Plasma, Serum 500 µl(Manual Extraction) 1 ml (Automated Extraction)

AMPLICORTM HIV-1 DNA Test v1.5* PCR, qualitative

Type of assay

Dynamic Range (copies/ml) Specimen Type Specimen volume

50–100,000 (UltraSensitive)400–750,000 (Standard) Plasma, Serum 200 µl (UltraSensitive) 500 µl (Standard)

50–100,000 (UltraSensitive) 500–1,000,000 (Standard) Plasma, Serum 500 µl (US. Manual Extraction) 750 µl (US,Automated Extraction) 200 µl (Std, Manual Extraction) 350 µl (Std, Automated Extraction) Gag

N/A

Whole Blood, DBS 200–500 µl

Area of HIV genome amplified HIV-1 subtypes amplified Time for resultCost/test1

Gag

Gag

Gag

Group M, subtypes A–H

Group M, subtypes A–H

Group M, subtypes A–H

Group M, subtypes A–H

7–8 hours $ 17–35/test $ 35–90/ test 9–21

6–8 hours $ 17–35/test$ 35–90/test 9–21

5–6 hours $ 17–35/test $ 35–90/test 21–84 (COBAS TaqMan 48 or 96) COBAS TaqMan 48 or 96 COBAS AmpliPrep – automated extraction (Optional)

7–8 hours $ 10–15 / test $ 15–30 /test 9–21

Number of samples/run Equipment required2

Thermocycler, ELISA Reader/Washer, Microcentrifuge Not supplied by Roche Total approx $25,000.

COBAS AMPLICOR (PCR) COBAS Ampliprep –automated extraction (Optional)

Thermocycler, ELISA Reader/Washer, Microcentrifuge Not supplied by Roche Total approx $25,000.

Equipment cost (US$)

COBAS AMPLICOR: $35,000–45,000 AmpliPrep: $80,000–100,000

COBAS TaqMan 48 or 96: $45,000–$60,000/ $120,000 AmpliPrep: $80,000– $100,000

* Research use only
1

Prices will vary considerably depending on quantities, infrastructure and...