Products/Aptima HIV-1 Quant Dx Assay

Aptima HIV-1 Quant Dx Assay

Hologic
PMA ApprovedCE-IVD

Quantification of HIV-1 RNA for monitoring antiretroviral therapy

Technical Specifications

PlatformPanther
MultiplexNo
Target Count1
Sensitivity≥99%
Specificity≥99%
Turnaround Time3 hr
Storage Temperature2–8°C
Shelf Life12 months

Pathogen Targets (1)

HIV-1/2· virus

Sample Types

Plasma

Detection Methods

NAAT

Regulatory Status

FDAPMA Approved

P150047

PMA

6/9/2016

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $25–$50

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.