PubMed · 3321178
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A Tuji, M Maeda. 1987. [Detection methods for immunoassay].. https://pubmed.ncbi.nlm.nih.gov/3321178/
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Astroviruses are small RNA viruses associated with pediatric gastroenteritis. A latex agglutination (LA) test is more convenient and rapid than electron microscopy, enzyme immunoassay (EIA) and reverse transcription-polymerase chain reaction (RT-PCR) for detection of astroviruses in stool specimens was developed by using polyclonal antibody against cultured serotype 1 astrovirus, and tested on astrovirus positive- and negative- samples collected between 1985 and 1993 in Ehime, Japan. Cultured serotype 1 astrovirus was detected by the LA test, but serotype 2, 3, 4, 5, 6, and 7 viruses could not be detected, although they yielded high titer of the viruses. When tested on the 27 clinical samples, all 8 serotype 1 astroviruses determined previously by EIA were positive by the LA test, however, 9 other serotype astroviruses and 10 astrovirus negative-samples were all negative. PT-PCR was found to be the most sensitive followed by EIA and LA test. Further development of LA test with other serotypes is necessary.
Technology with solid-phase enzyme immunoassay was markedly progressed. Kinds of solid-phase are as follows; (1) tube, (2) beads, (3) latex particle, (4) microtiter plate, (5) ferrite particle, (6) membrane. Recently, application of avidin/biotin system to the tube method was accomplished. As one of the B/F separation with beads method, spin washing method was also developed. Automated open system with the beads method was also developed. Microtiter plate using sponges as the solid-phase was routinely used for allergy tests (CAP-RAST). Multi-Access Open System (MAOS), applicable for various kinds of ELISA kit, will appear in Japan near future. Latex particle with ferrite plating and ferrite particle with glass coating were also used as the solid-phase of EIA. HCV-RIBA II and III systems using nitro-cellulose membrane as solid-phase were also described.
Although the basic concept for quality control of enzyme immunoassay (EIA) is the same as that of quality control of the usual chemical analysis, immunological analytic methods including enzyme immunoassay have some specific features depending on the method as compared with the chemical method. In addition to the usual QC method, therefore, it is necessary to add some QC techniques to control the variables derived from the method. In accuracy control of EIA, standard materials, reagents and analytical equipment will be the major sources of error. Points to be considered in accuracy control are described. In precision control of EIA, between-run precision is generally larger than within-run precision. In consideration of the characteristics, mean-Rs-R control chart method and Z-V control chart method appropriate for immunological method are described. Analytical sensitivity expressed as detectability and detection limits is very important in EIA. A procedure to determine the detection limits is described in detail. Between reagent lot difference in immunological reagent is considerably larger than that of chemistry reagent and a shift of the point on the control chart is not adequate to assess the reliability of the patient data. Therefore, an evaluation method of the between reagent lot difference is described. General procedures of precision control are not described here because the procedures are well known.