Children can't wait for health care reform.

There is widespread agreement that the American health care system needs comprehensive reform. This kind of reform will take time, however, and millions of Americans have urgent health care needs that must be met now. This is especially true for the nation's poor children, for whom the health care "safety net" has greatly eroded in the past decade. New Jersey's health care reform initiatives will ultimately provide for accessible preventive and primary pediatric care, with a community-based "medical home" serving as a child's gateway to the health care system. In the meantime, New Jersey has established programs dealing with such urgent problems as infectious childhood diseases, lead poisoning, AIDS, and infant mortality. While in the spirit of the state's long-range planning effort, these programs are up and running now, their impact maximized in this period of budgetary constraints through coalition- and network-building.

Automated microparticle enzyme immunoassays for IgG and IgM antibodies to Toxoplasma gondii.

Fully automated microparticle enzyme immunoassays (MEIA) for the IMx immunoassay analyser were developed to detect IgG and IgM antibodies to Toxoplasma gondii. The IgG MEIA results are expressed in International Units (IU) of IgG antibody interpolated from a six point calibration curve covering the range from 0 to 300 IU/ml. Reproducible results were obtained from a calibration curve stored in the instrument for at least one month. The qualitative IgM MEIA expresses results as an index using a single calibrator included in each run. The Toxo IgG MEIA and Toxo IgM MEIA were in 98% and 97% agreement, respectively, with the reference assays used. Twenty four sera can be completely processed in about 35 minutes.

Development of automated immunoassays for immune status screening and serodiagnosis of rubella virus infection.

The fully automated IMx immunoassay analyzer was used to develop a system for the detection of IgG and IgM antibodies to rubella virus for immune status screening and diagnosis of primary infections. Reagents and assay protocol software were developed using rubella virus sensitized microparticles as the solid phase to capture specific antibodies from serum samples. Anti-human IgG or IgM antibody coupled to alkaline phosphatase enzyme followed by methylumbelliferyl phosphate substrate was used to detect the presence or absence of antibodies specific to the antigens on the solid phase. To evaluate the efficacy of the IMx rubella IgG assay, immune status screening was performed with a clinical patient population of 501 sera. When compared to an IgG specific enzyme immunoassay and passive hemagglutination assay the agreement was greater than 99%. The IMx rubella IgM assay was utilized to determine the presence of rubella specific IgM antibodies in 462 sera. These results were compared to IgM specific enzyme immunoassay results and also demonstrated greater than 99% agreement. Seroconversion following rubella vaccination of susceptible individuals was demonstrated by IgG and IgM antibody responses as early as two weeks postvaccination. In addition to automation, the IMx system offers rapid assay times and calibration curve storage without sacrificing clinical efficacy.

TestPack Chlamydia, a new rapid assay for the direct detection of Chlamydia trachomatis.

TestPack Chlamydia (Abbott Laboratories) is a rapid enzyme immunoassay for the direct antigen detection of Chlamydia trachomatis in endocervical specimens. The assay is self-contained, requires no specialized equipment, and yields results in less than 30 min. The clinical performance of TestPack Chlamydia versus chlamydial cell culture was evaluated with a total of 1,694 paired endocervical specimens. Discordant samples were further investigated by immunofluorescent staining and by Chlamydiazyme immunoassay, with confirmatory procedures. The sensitivity of TestPack Chlamydia with less-than-48-h-old specimens was 76.5%, while culture sensitivity was 86.7%. TestPack Chlamydia specificity was determined to be 99.5%. These results indicate that TestPack Chlamydia is an accurate test for chlamydial infection, with a positive predictive value of 96.2%. This assay is suitable for low-volume chlamydial testing in physician offices, clinics, and smaller laboratories.

Evaluation of a rapid passive hemagglutination assay for anti-rubella antibody: comparison to hemagglutination inhibition and a vaccine challenge study.

A rapid passive hemagglutination assay (Rubaquick) was developed that detects antibody to rubella virus in serum specimens. The test result is read visually after an incubation period of 15-30 minutes. When compared with a hemagglutination inhibition assay, the Rubaquick assay results obtained from 1,470 sera were greater than 99% specific, sensitive, and accurate. Studies of 179 paired serum specimens obtained before and 27 days after rubella vaccination showed that if antibody was detectable by the Rubaquick assay in the prevaccination specimens, the vaccine induced a secondary response consisting of increasing IgG antibody reactivity in the absence of a positive IgM response. In contrast to the positive prevaccination specimens, a negative prevaccination result was associated with IgM antibody in 98 of the 133 postvaccination specimens. Seroconversion was noted in all cases in which the prevaccination specimen was negative by the Rubaquick assay.

Clinical evaluation of the sensitivity and specificity of a commercially available enzyme immunoassay for detection of rubella virus-specific immunoglobulin M.

A solid-phase capture antigen enzyme immunoassay (Rubazyme-M) was evaluated for sensitivity and specificity on sera from 1,200 blood donors, 51 patients with rubella, 2 infants with congenital rubella, 104 patients with other infections, and 126 patients with immunological abnormalities. The sensitivity was 100% for sera tested between days 3 and 40 after the onset of symptoms of rubella virus infection. Rubella virus-specific immunoglobulin M was detected at birth in sera from congenitally infected infants and persisted for several months. Positive Rubazyme-M responses were observed in some patients in the absence of rubella diagnosis (one blood donor, three other infections, and two immunological abnormalities), providing a test specificity of 99.6%. None of 67 patients with rubella virus-specific immunoglobulin G antibody and high levels of rheumatoid factor were positive in the test.

Signet ring cell carcinoma of bladder.

The ninth reported case of primary signet ring cell carcinoma of the bladder is described. This particular tumor, whose histology was examined repeatedly during its evolution, showed an interesting change in microscopic appearance after irradiation. The emerging features of signet ring cell carcinoma of the bladder are discussed.