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Document 2736
DOCN M94A2736
TI HIV-1 p24 quality assurance and standardisation of enzyme immuno assays.
DT 9412
AU Best SJ; Healey DS; Silvester C; Dax EM; National HIV Reference
Laboratory, Fairfield Hospital, Australia.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):236 (abstract no. PB0375). Unique
Identifier : AIDSLINE ICA10/94369839
AB AIMS: (i) To evaluate antigen assays for quantitative use with and
without immune complex disruption (ICD). (ii) To compare quantitative
results of quality assurance (QA) samples. (iii) To investigate whether
results obtained from different assays show improved comparability when
the same antigen standard is used to construct the standard curve in
each assay. METHODS: Five commercial p24 antigen assays were evaluated
using four p24 antigen preparations and 150 sera from HIV-1 positive
subjects, all in dilution series. The antigen preparations included one
recombinant protein (American Biotechnologies, Inc.) and three from
viral lysate. A whole viral lysate preparation from CSL Limited
(CSL-071) was chosen as a potential standard for national use in antigen
assays and sent, with three QA samples to the four laboratories of the
Clinical Trials Group. Results of QA samples were calculated from the
standard curves provided in the kits as well as from the standard curve
constructed from the CSL-071 dilution series. RESULTS: All assays
provided approximately linear results (correlation coefficients
0.96-0.99) with all antigens. This was not always true when ICD
procedures were used. The range of antigen concentrations over which the
readings were linear varied between native and recombinant antigens:
6-100 pg/ml and 10-1,000 pg/ml respectively. Results of QA samples
calculated from the CSL-071 dilution series were comparable between
laboratories and between assays but when calculated from kit standard
curves showed wide variation (e.g. mean 66pg/ml range 60-72pg/ml vs
100pg/ml with range 52-134pg/ml). CONCLUSIONS: (i) p24 EIAs are
generally suitable for quantitation but not always with ICD procedures.
(ii) Viral lysate and recombinant antigens behave differently in p24
antigen assays. (iii) Standard antigen preparations may be the most
appropriate method to achieve reproducible results.
DE Comparative Study Human HIV Core Protein p24/*BLOOD HIV
Seropositivity/*DIAGNOSIS/IMMUNOLOGY HIV-1/*IMMUNOLOGY *Immunoenzyme
Techniques Predictive Value of Tests *Quality Assurance, Health Care
MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).