Variability of reporting and lack of adherence to consensus guidelines in human T-lymphocyte immunophenotyping reports: results of a case series.

Percentages and absolute counts of CD4+ lymphocytes, as determined by T-lymphocyte immunophenotyping (TLI), are prognostic, as well as diagnostic, of the course of human immunodeficiency virus type 1 infections and are important indicators for initiating Pneumocystis carinii pneumonia prophylaxis and antiretroviral therapy. In December 1990, we requested that a nonrandom sample of 17 laboratories provide us with typical reports of their TLI results from an immunodeficient patient and from a patient whose TLI results were within the laboratory's normal reference ranges. We also searched published literature and documents proposed by professional organizations for recommendations regarding T-lymphocyte testing and reporting. This article compares guidelines for reporting TLI results, as proposed by the National Committee for Clinical Laboratory Standards in Document H42-P, with samples of reports obtained in our case series. Most reports follow some, but not all, of the proposed guidelines. A majority of the laboratories provided interpretations of the results in their reports. We found considerable variation in normal reference ranges. We describe this variation in detail for the CD4+ T-lymphocyte counts and CD4+ T-lymphocyte percentages. This article describes some of the TLI result report forms currently being used and identifies important quality issues in this rapidly expanding area of clinical laboratory testing.

HTLV-I among U.S. Marines stationed in a hyperendemic area: evidence for female-to-male sexual transmission.

Among 5,255 active duty United States Marines on permanent tour in Okinawa, Japan, screened for human T-cell leukemia/lymphoma virus type I (HTLV-I) seropositivity, 3 (0.06%) were confirmed by Western blot analysis to have core and envelope reactivity. All three seropositive individuals have a history of prolonged sexual contact with Okinawan women, and two of the three individuals are married to seropositive Okinawan wives. Two gave a prior history of gonorrhea, while all three were negative for syphilis (MHA-TP) and hepatitis B. No other risk factors associated with HTLV-I seropositivity in the United States were identified. A banked sample from one individual, obtained 8 months after initial sexual relations with his HTLV-I-seropositive Okinawan spouse and 20 months before being retested in the survey, showed a pattern suggesting seroconversion. Although based on small numbers, these data suggest that female-to-male transmission of HTLV-I occurs in the absence of other cofactors, e.g., ulcerative genital lesions.

Content and design of laboratory report forms for human immunodeficiency virus type 1 antibody testing.

In a pilot study involving proficiency testing for human immunodeficiency virus, markedly diverse and potentially confusing test report forms were encountered among participating laboratories. Therefore, a comprehensive study of human immunodeficiency virus type 1 report forms was conducted from state-licensed testing laboratories in California. Participants analyzed three serum samples of known human immunodeficiency virus type 1 antibody reactivity and reported their results on forms that they would normally submit to clinicians. Report forms from 84 laboratories were evaluated for content, design, and clarity. Differences were found among commercial, hospital, and public health laboratories. The significance of these findings is discussed. This technique also may be applied to evaluate laboratory report form design and content for other diagnostic test results.

Prevalence of human T cell lymphotropic virus types 1 and 2 (HTLV-1/2) in selected Tijuana subpopulations.

To assess the prevalence of human T cell lymphotropic virus type 1 and 2 (HTLV-1/2) infections among potentially high-risk populations in the city of Tijuana, Mexico, the prevalence of specific antibodies was determined and information on risk behaviors was obtained between June and October 1988. The study involved 631 presumably healthy individuals, randomly selected from a study population recruited sequentially from prisoners, prostitutes, and injecting drug users (IDUs), and randomly from homosexual and bisexual men. The presence of HTLV-1/2 antibodies was determined by enzyme immunoassay and an immunofluorescence method, and positive reactions were confirmed by a radioimmunoprecipitation assay and Western blot. The prevalence of HTLV-1/2 was 2% (2 of 105) among prostitutes, 7% (29 of 410) among prisoners, 1% (1 of 105) among homosexual/bisexual men, and 21% (22 of 106) among IDUs. To properly identify the specific HTLV type, a subsequent sample of 41 imprisoned IDUs were voluntarily and anonymously recruited in June 1990 and asked to donate 20 ml of whole blood. Twenty-two percent (9 of 41) were serologically positive for HTLV-1/2, and polymerase chain reaction analysis performed on peripheral blood mononuclear cells identified HTLV-2 as the specific virus prevalent in this group. Two individuals were positive for human immunodeficiency virus type 1 (HIV-1). One of these individuals was coinfected with HTLV-2.(ABSTRACT TRUNCATED AT 250 WORDS)

Prevention of hepatitis B transmission in Indo-Chinese refugees with active and passive immunization.

Hepatitis B is a cause of disability and death worldwide, with high rates of perinatal transmission in third world countries, including those of Indochina. Prevention of transmission by active and passive immunization has been available since 1982. This study looked at the serological response of Indo-Chinese refugees to these products in an outpatient primary care clinic and at the compliance problems found in this setting. The carrier rate of all patients screened was 81/446 (18.5%), with 37/233 (15.8%) of prenatal patients as carriers. Newborns whose mothers were carriers were started on an immunization program. The combination of HBIG and vaccine was more than 90% effective in inducing immunity and preventing the carrier state; only two children of the 26 studied who received both active and passive immunization became carriers. Both failures were in children of HBeAg positive mothers. In contrast, those children exposed who had not received treatment (because of birth prior to 1982) had a 33% carrier rate. This success rate was found despite compliance problems in completing the immunizations on schedule. Only 23% of children received their vaccine within four weeks of the recommended schedule, with a mean delay of 1.3 months. Of the 79 children beginning immunizations, 11 moved before completion. All children remaining in San Diego completed the regimen. Thus, the benefits of giving the passive and active immunization to infants of hepatitis B carriers were clear. However, compliance problems jeopardize the effectiveness of a hepatitis B immunization program in this population.(ABSTRACT TRUNCATED AT 250 WORDS)

Methods for a model blind proficiency testing system.

The method developed for establishing a blind proficiency testing (PT) system is presented. The Laboratory Assurance Program of the Graduate School of Public Health at San Diego State University is developing and pilot testing innovative strategies that will evaluate and improve the performance of clinical laboratories. To date, a total of 32 laboratories have been incorporated into this program along with 12 counseling and testing sites. From June 1988 to December 1989, five blind PT surveys for human immunodeficiency virus type 1 antibody testing were conducted, representing 306 proficiency specimens entered into the testing system as simulated patient specimens. Despite the difficulties and expense involved, we found the system to be acceptable and to have certain advantages over conventional methods of external testing.

T-lymphocyte immunophenotyping blind proficiency testing: a model system for CD4+ T-cells.

OBJECTIVE: To develop and evaluate methods and results for blind proficiency testing for CD4+ T-cells by T-lymphocyte immunophenotyping. DESIGN: A model system was developed to submit duplicate specimens for T-lymphocyte immunophenotyping as if they were routine patient specimens rather than proficiency specimens. Testing results were compared both interlaboratory and intralaboratory. The model system was designed to gather information on not just the analysis, but other segments of the total testing process. SETTING: Research facilities at the Graduate School of Public Health, San Diego State University, San Diego CA. PARTICIPANTS: 1) A healthy adult volunteer donating one pint of blood. 2) Laboratories offering T-lymphocyte immunophenotyping. MAIN OUTCOME MEASURES: 1) Feasibility of blind proficiency so that PT specimens are received, analyzed, and reported by laboratories without being identified as 'proficiency specimens.' 2) The ease and cost of such a system. 3) The comparability of results and report content among laboratories. RESULTS: A total of twenty-two laboratories received blind proficiency specimens. The model developed to submit specimens and receive results proved feasible. The interlaboratory coefficient of variation for CD4+ count for the four survey years ranged from 10% to 66% and for the CD4+ percent ranged from 4% to 15%. The per specimen cost in this blind proficiency testing was $437.65, approximately seven and a half times the cost for nonblinded proficiency testing or performance evaluations. CONCLUSIONS: Blind proficiency as a tool to compare laboratory test results for T-lymphocyte immunophenotyping is feasible but adds costs. The model system is useful to examine more of the laboratory total testing process than the analysis segment.

Analytic results of HIV-1 testing using blind proficiency testing.

The use of blind proficiency testing (PT) to examine analytic performance of human immunodeficiency virus type 1 (HIV-1) antibody testing. A total of 32 hospital, blood bank, public health, and commercial laboratories were included in this study. Test sera were introduced as clinical specimens for HIV-1 testing from private practitioners, group practices, clinics, and hospitals in Southern California. A total of 26 laboratories were located throughout California, with six laboratories located in six other states. Results from 306 enzyme immunoassay screening tests and 192 supplemental tests for HIV-1 were reported. Although one positive specimen was reported as indeterminate in almost 30% of results, screening and supplemental testing performances were excellent, with accuracy levels comparable to performance reported on open PT and performance evaluation surveys in the United States. The indeterminate results were attributed to the interpretive criteria used rather than to laboratory errors. Blind PT can be an important tool in improving the quality of total laboratory testing, the usefulness of laboratory results in patient care, and ultimately the health of the public.

Identification of nonanalytic issues in HIV-1 antibody testing using blind proficiency testing.

Blind proficiency testing was used to examine nonanalytic performance indicators for human immunodeficiency virus type 1 (HIV-1) antibody testing. Physician offices, clinics, and hospitals located throughout Southern California submitted simulated patient specimens to laboratories as routine test requests. A total of 32 laboratories were involved during five blind proficiency testing surveys. Turnaround time for a reactive specimen ranged from three to 17 days. Laboratory charges for evaluating a reactive specimen varied depending on the volume of testing, prevalence of reactive specimens, and whether screening and confirmatory tests were billed separately or as a package price. Charges for an enzyme immunoassay screening test plus supplemental tests ranged from $11.75 to $114.50, with a median of $31.00 for 24 laboratories that participated in one of the five surveys. Evaluation of laboratory report content revealed that 37% of the 16 screening reports and 71% of the 14 supplemental reports contained information that was unrelated to the patient results. Evaluation of the testing system documents the need to monitor multiple outcomes of the total laboratory testing process, not just the analytic testing phase.

AIDS update.

Acquired immunodeficiency syndrome (AIDS) is a new and frightening epidemic. Epidemiology has clearly delineated the mechanisms of spread as sexual intercourse, transfer of blood, and vertical transfer from infected mother to newborn child. Although much remains to be answered about infection with the AIDS virus, present information will allow containment of its spread while methods of controlling the threat, such as development of vaccine and therapy, are vigorously pursued.

[Sexual behavior and drug abuse in homosexuals, prostitutes and prisoners in Tijuana, Mexico]. / Comportamiento sexual y abuso de drogas en homosexuales, prostitutas y prisioneros en Tijuana, Mexico.

PIP: Results are presented of a sociodemographic and epidemiologic survey conducted between July-October 1988 in Tijuana, Mexico, among 3 subgroups believed to be at high risk of HIV infection. 383 female and 32 male prostitutes recruited at the Municipal Medical Services clinic in Tijuana, 376 male and 34 female prisoners recruited ate the State Penitentiary, 233 male homosexuals and bisexuals recruited in bars and other meeting places, and 11 drug addicts treated at a detoxification program were successfully interviewed. Although only 11 iv drug addicts were located and agreed to participate, 5 prostitutes, 85 prisoners, and 5 homosexual/bisexual reported histories of iv drug use. The homosexual/bisexual group was relatively younger and better educated,and had higher incomes than the other groups. The average age was 25.6 for homosexual/bisexuals, 29.5 for prostitutes, and 29 for prisoners. 82.7% of homosexual/bisexuals, 46.3% of prostitutes, and 44.4% of prisoners were single. Among prostitutes and prisoners, respectively, 6.5 and 25.9% were married and 22.2 and 18/5% were in consensual unions. The average number of years of schooling were 10.3 for homosexual/bisexuals, 5.6 for prostitutes, and 6.3 for prisoners. Male prostitutes reported the highest average number of sexual partners in the past year (261 +or- 341), prisoners reported the greatest frequency of iv drug users as sexual partners, and homosexual/bisexuals reported the highest frequency of receptive anal intercourse. 35% of respondents reported a history of sexually transmitted diseases. 36% of female prostitutes and 4% of prisoners reported using condoms regularly during vaginal intercourse. 25% of homosexual/bisexuals reported using condom regularly during anal intercourse. 31% of respondents reported having been tested previously for HIV antibodies,but only 41% of those knew the results. 72 homosexual/bisexuals, 56 prostitutes, and 126 prisoners reported having had sexual relations in the US. 80% of respondents reported consuming alcohol, 64% cigarettes, and 28% illegal drugs. The most frequently used illegal drug was marijuana. 68% of the 106 identified iv drug users continued to use drugs. The rest reported having used them since 1978. The introduction of HIV into these subpopulations has been slow but steady. Infection rates in this sample were .5% for prostitutes, 1.2% for prisoners, 11.6% for homosexual/bisexuals, and 1.9% for the 106 iv drug users.^ieng

[Development of a rehydration therapy in diarrheic disease. 1980]. / Desarrollo de una terapia de rehidratación en la enfermedad diarreica.

Intravenous rehydration is required only in patients with severe diarrhea due to V. cholerae who are in shock, with absent peripheral pulse and blood pressure; when the shock has been corrected, rehydration can be completed using an oral rehydration solution. The intravenous solution to be used is 5:4: 1 (5g of sodium chloride, 4g of sodium bicarbonate and 1g of potassium chloride per liter) or a comparable commercial alkaline solution. For oral rehydration a solution is used containing 3.5 g sodium chloride, 2.5g sodium bicarbonate, 1.5g potassium chloride and 20g of glucose (or 40g of sucrose) per liter. These fluids are administered in a volume replacing the amount lost before treatment was initiated and the fluids lost in the continuing diarrhea. With this management, a case fatality rate of 50% in the untreated falls to less than 1%. The addition of antibiotics such as tetracycline and furazolidone reduces the duration of diarrhea and the need for continuing fluid balance observation. Intravenous rehydration of severe diarrhea cases with normal saline solution or with 5% glucose solution increases the acidosis with resulting veno-constriction, which favors the pooling of blood in the heart and the pulmonary circulation leading to cardiac overload and then failure and circulatory peripheral collapse. When acidosis is corrected by the sodium bicarbonate solution and with adequate fluid replacement, normal hemodynamics are reestablished and the patient immediately recovers from the collapse. In cases of mild or moderate diarrhea, replacement entirely by oral rehydration of the estimated volume of lost fluid alone is usually sufficient. This management of diarrhea is applicable for diarrhea from any cause, including enterotoxigenic Escherichia coli, Rotavirus, Salmonella and Shigella as well as Vibrio cholerae.

Immunization and military medicine.

This lecture, a memorial to Joseph E. Smadel, reviews the involvement of the military in the development and use of immunizing materials. Smallpox and smallpox immunization in the military and the development and present status of immunization against typhoid, cholera, yellow fever, typhus, tetanus, diphtheria, plague, influenza, adenovirus, meningitis, rubella, and malaria are reviewed. Dr. Smadel's personal contributions to the significant achievements of the military program to civilian practice are emphasized.

Phage resistance in Vibrio cholerae.

Mukerjee cholera phages are being extensively used in the classification of vibrios. However, the studies reported here show that phage-resistant mutants that are exactly like the parent strains in all characteristics except phage reactions can easily be obtained. For this reason phage reactions should be considered only as a marker and not as the final arbiter in vibrio classification, e.g., in attempting to identify the El Tor vibrio. Confirmatory evidence should always be sought.It is also shown that routine phage work can be simplified by preparing phage-specific hosts and using them for the preparation of phage stocks without any fear of cross-contamination. The properties of phages prepared on the specific hosts are similar to those of phages prepared on the universal host.