- Vysis FISH
- Abbott REAL-TIME PCR
- Ordering Information
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|Product Name||Unit Size||Order Number||GTIN|
The Abbott RealTime HIV-1 assay is an in vitro reverse transcriptionpolymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) on the automated m2000 System in human plasma from HIV-1 infected individuals over the range of 40 to 10,000,000 copies/mL. The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
Limitations of the Procedure
Warnings and Precautions
IMPORTANT: Amplification reagents that will be used a second time must be stored at –25 to –15°C within 50 minutes of the initiation of the master mix addition protocol.
To learn more about RealTime HIV-1 please visit: https://www.molecular.abbott/us/en/products/infectious-disease/realtime-hiv-1-viral-load
|Abbott RealTime HIV-1Plasma|
|Limit of Detection||40 copies/mL for 1.0 mL sample volume
40 copies/mL for 0.6 mL sample volume
75 copies/mL for 0.5 mL sample volume
150 copies/mL for 0.2 mL sample volume
|Linear Range||40 copies/mL (1.6 log copies/mL) to 10 million copies/mL (7.0 log copies/mL)|
|Target region||Integrase region of polymerase gene|
|Subtype Detection||Group M subtypes A—H, Group O and Group N|
|Internal control||Non-competitive pumpkin RNA, added to lysis buffer during extraction|
|Standardization||Virology Quality Assurance (VQA) Laboratory of the AIDS Clinical Trial Group; World Health Organization (WHO) 1st International Standard for HIV-1 RNA (97/656)|
|Specimen Type||Plasma (ACD-A and EDTA)|
|Input volume||0.2 mL; 0.5 mL; 0.6 mL; 1.0 mL|
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