[A comparative study of the sensitivity and specific activity of an immunoenzyme test system for determining class-M antibodies to the hepatitis A virus]. / Sravnitel'noe izuchenie chuvstvitel'nosti i spetsificheskoi aktivnosti immunofermentnoi test-sistemy dlia opredeleniia antitel klassa M k virusu gepatita A.

The diagnostic value of the first experimental production batches of assay kit "DIAGN-A-HEP", produced at the Institute of Poliomyelitis and Viral Encephalitides (USSR Acad. Med. Sci.) and intended for the determination of IgM to hepatitis A virus (HAV) in the enzyme immunoassay (EIA), has been studied in comparison with that of the internationally known and widely approved commercial EIA system "HAVAB-MEIA" for the determination of antibodies to HAV (the product of Abbott, USA). The study has revealed that the EIA kit "DIAGN-A-HEP" is highly sensitive and specific, and the diagnostic value of this kit is not inferior to that of the commercial assay system "HAVAB-MEIA". On the basis of this study the use of the EIA kits "DIAGN-A-HEP" in medical practice has been allowed by the decree of the Ministry of Health of the USSR.

[The immunogenicity of a cultured inactivated hepatitis A vaccine]. / Immunogennost' kul'tural'noi inaktivirovannoi vaktsiny gepatita A.

A trial of inactivated hepatitis A viral vaccine of heteroploid cell culture origin is described. The vaccine preparation was tested in guinea pigs and tamarins. The animals were immunized intramuscularly four or three times, respectively. The efficacy was judged by induction of anti-HAV antibody persisting for at least 12 months in guinea pigs, and development of immunity to subsequent virus challenge (monkeys only). The challenge dose of HAV was unable to produce any signs of HAV infection in the vaccinated tamarins, although the booster effect was observed in some animals. The study demonstrated that the tested batches of the vaccine were highly immunogenic.

[Trial of a Soviet diagnostic kit for determining class M immunoglobulins to the hepatitis A virus by immunoenzyme analysis (an anti-HAV IgM test system)]. / Ispytanie otechestvennogo diagnosticheskogo komplekta dlia opredeleniia immunoglobulinov klassa M k virusu gepatita A immunofermentnym analizom (test-sistema na anti-VGA IgM).

The authors have studied the effectiveness of the first Soviet test system for the diagnosis of hepatitis A by means of the enzyme immunoassay (Diagn-A-Hep), developed at the Institute of Poliomyelitis and Viral Encephalitides, Moscow, under the conditions of different epidemic situations. In the process of this trial the high specificity and sensitivity of this test system, established earlier in the certification and commission trials, have been confirmed. Diagn-A-Hep has proved to be highly effective in the diagnosis of acute forms of hepatitis A and permitted its detection in patients during the incubation period, as well as in patients with anicteric and asymptomatic subclinical forms. Besides clinical diagnosis, the kit Diagn-A-Hep may be used in large-scale seroepidemiological surveys of the immune structure of the population, as well as in detection of HAV in different material under test.

[Development of a Soviet diagnostic kit for determining class M immunoglobulins to the hepatitis A virus by immunoenzyme analysis (a test system for anti-HAV IgM)]. / Razrabotka otechestvennogo diagnosticheskogo komplekta dlia opredeleniia immunoglobulinov klassa M k virusu gepatita A immunofermentnym analizom (test-sistema na anti-VGA IgM).

A new test system Diagn-A-Hep for the laboratory diagnosis of hepatitis A (HA) by means of the enzyme immunoassay has been developed at the Institute of Poliomyelitis and Viral Encephalitides (Moscow). The sensitivity and specificity of the newly developed test system have proved to be similar to those of the well-known commercial diagnostic system HAVAB manufactured by Abbott Laboratories (USA). Diagn-A-Hep permits the diagnosis of HA with 96-100% effectiveness both in patients with the acute form of the disease and in patients with its anicteric or inapparent forms. This system is simple and convenient, it may be employed in inadequately equipped laboratories or even under field conditions. The rules for the selection of immunobiological preparations to be included in the test system have been worked out.