Abbott RealTime HIV-1

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Product Description
SPECIFICATIONS
Product Description

Intended Use

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

  • FOR IN VITRO DIAGNOSTIC USE
  • Optimal performance of this test requires appropriate specimen collection, handling, preparation, and storage (refer to the SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE section of this package insert)
  • Human plasma specimens collected in ACD-A or EDTA tubes may be used with the Abbott RealTime HIV-1 assay.
  • Use of the Abbott RealTime HIV-1 assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Abbott m2000sp and the Abbott m2000rt instruments.
  • The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in this package insert.
  • A specimen with a result of "Target not detected" cannot be presumed to be negative for HIV-1 RNA.
  • As with any diagnostic test, results from the Abbott RealTime HIV-1 assay should be interpreted in conjunction with other clinical and laboratory findings.

Warnings and Precautions

  • This assay is not intended to be used as a screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
  • The Abbott RealTime HIV-1 reagents are intended to be used only on the Abbott m2000 System consisting of the m2000sp for sample processing and the m2000rt for amplification and detection.
  • Only use uracil-N-glycosylase (UNG) (List No. 6L18-67) when performing the uracil-N-glycosylase protocol.
  • Do not use expired reagents.
  • The Abbott m2000sp Master Mix Addition protocol must be initiated within 1 hour after completion of Sample Preparation. If the Abbott m2000sp master mix addition protocol is aborted, seal the Abbott 96-Well Optical Reaction Plate in a sealable plastic bag and dispose according to the m2000sp Operations Manual, Hazards section, along with the gloves used to handle the plate. Do not import the test order onto the m2000rt.
  • The appropriate PCR plate must be selected when samples are loaded into the m2000rt instrument. New reagent packs being used for the first time may be saved and stored for later use as described in this package insert.
  • The m2000rt protocol must be started within 50 minutes of the initiation of the Master Mix Addition protocol. If the Abbott m2000rt instrument run is not initiated within 50 minutes, or is interrupted or aborted, seal the Abbott 96-Well Optical Reaction Plate in a sealable plastic bag and dispose according to the Abbott m2000rt Operations Manual along with the gloves used to handle the plate.
  • Amplification reagent packs containing prepared master mix may be stored at –25 to –15°C, capped and protected from light, for up to 7 days before a second use. The IC may be used again within 14 days if the vial remains capped at –25 to –15°C, until the second use.
  • 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.

Rx Only

To learn more about RealTime HIV-1 please visit: https://www.molecular.abbott/us/en/products/infectious-disease/realtime-hiv-1-viral-load

SPECIFICATIONS
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)
Specificity 100%1
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
Sample preparation m2000sp
1The specificity of the RealTime HIV-1 assay was evaluated at three external sites by testing 514 HIV-1 seronegative plasma specimens from volunteer blood donors. HIV-1 RNA was not detected for all 514 specimens and the RealTime HIV-1 assay specificity was estimated to be 100% (514/514), (95% CI 99.28 to 100%).

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