ASTM E2146-01
Standard Guide for Detection of Nucleic Acid Sequences of the Human Immunodeficiency Virus HIV-1 by the Polymerase Chain Reaction Technique
- Standard No.
- ASTM E2146-01
- Release Date
- 2001
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- 2010-02
- Latest
- ASTM E2146-01
- Scope
This guide is intended for use in any laboratory utilizing PCR to amplify DNA sequences or RT-PCR to amplify RNA sequences of HIV from cells, tissues, or body fluids such as whole blood, sera and plasma.
The criteria used for the identification and evaluation of the amplification reactions should be administered by an individual trained in the use of molecular biological and microbiological techniques associated with PCR and HIV.
1.1 This guide covers considerations, criteria, principles and recommendations that should be helpful when developing, utilizing, or assessing PCR protocols to amplify and detect DNA (by PCR) or RNA [by reverse transcriptase PCR (RT-PCR)] from HIV. This guide is not a specific protocol for the detection of HIV. It is intended to provide information that will assist the user in obtaining quality and reliable data. The guide is closely related to and should be used concurrently with the general PCR guideline E 1873.
1.2 This guide has been developed for use in any molecular biology or biotechnology laboratory. This includes but is not limited to clinical and diagnostic laboratories involved with HIV detection.
1.3 This guide does not cover details of the various methods such as gel electrophoresis, that can be utilized to identify PCR-amplified HIV nucleic acid sequences, nor does it cover details of instrument (thermocycler) calibration.
1.4 This guide does not cover specific variations of the basic PCR or RT-PCR technology (e.g., quantitative PCR, multiplex PCR and in situ PCR).
1.5 This guide does not address the additional considerations necessary for the performance and validation of a quantitative PCR test for HIV.
Note 18212;Warning: Laboratory work involving certain clinical specimens and microorganisms can be hazardous to personnel.
Note 28212;Precaution: Biosafety Level 2 facilities are recommended for potentially hazardous work (2), and many laboratories use Biosafety Level 3 facilities when working with HIV. Safety guidelines should be adhered to according to NCCLS M29-A and other recommendations (2).
ASTM E2146-01 Referenced Document
- ASTM E1873 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique
ASTM E2146-01 history
- 2001 ASTM E2146-01 Standard Guide for Detection of Nucleic Acid Sequences of the Human Immunodeficiency Virus HIV-1 by the Polymerase Chain Reaction Technique
