[Procedures for optimizing the intralaboratory quality control in mass screening for hepatitis C virus antibodies].

The paper presents data on the optimization of intralaboratory quality control of tests for hepatitis C virus antibodies by enzyme immunoassay in the mass screening scope of studies. It is concluded that the control material prepared without assistance is suitable only to assess the convergence of the results of a study. The problems in the monitoring of the reproducibility of study results and in the standardization of on-line quality control involving the construction and keeping of control charts are solved by using standardized commercial materials and a computer-based data processing system.

[Absence of hepatitis C virus RNA in ambiguous results of mass blood screening for hepatitis C virus antibodies].

The purpose of the study was to elucidate whether hepatitis C virus (HCV) RNA was present in the blood of patients from a Moscow therapeutic-and-prophylactic institution with uncertain results of a study of anti-HCV that were obtained using the algorithm developed for mass screening. The two-stage scheme of testing the serum for anti-HCV, which was obligatory in accordance with the Order of the Ministry of Health of the Russian Federation, was supplemented by a study the samples having a low optical density samples and those with controversial results in the test systems with the expanded spectrum of detectable anti-HCV, the instructions of which comprises criteria for an uncertain result. Sera with uncertain results of anti-HCV tests were assessed by two polymerase chain reaction (PCR) techniques for HCV RNA. The cDNA fragments complementary to HCV RNA were detected in the sera obtained from two elderly persons in PCR when a signal was recorded in agarose gel. The other real-time PCR failed to detect RNA in none sera with an uncertain result as to anti-HCV.

[The theory and practice of using in-house control in screening and verification studies for the diagnosis of HIV infection]. / Teoriia i praktika primeneniia in-house-control v skriningovykh i veriferikatsionnykh issledovaniiakh po diagnostike VICh-infektsii.

Three batches of two diagnostic test kits for the in-house control (IHC) HIV infection were made up of the 8 pools of sera, containing antibodies to all antigens of HIV-1 (4) and HIV-negative sera (4) obtained from healthy donors. All sera used for this purpose did not contain antibodies to viruses of hepatitis A, B, C. In the process of the preparation of the batches of diagnostic test kits for IHC 500 individual donor sera and more than 100 of individual sera of HIV-infected persons were studied. The sera under study were also tested for the presence (absence) of specific antibodies to HIV-1,2 and viruses of hepatitis A, B, C. The evaluation of IHC in 300,000 tests under the conditions of a screening laboratory and 550 verification tests was done. The study revealed that the use of IHC makes it possible to improve the conditions of work with commercial diagnostic test kits, to introduce the semiquantitative determination of the level of specific antibodies on verification tests and, on the whole, to standardize the tests.