We report a 68-year-old man who received an IV inoculation of WBCs for an indium radionuclide scan containing 600 to 700 tissue culture infectious doses of human immunodeficiency virus type 1 (HIV-1) from an HIV-1-infected individual. The recipient immediately received zidovudine, then was switched to dideoxyinosine and interferon-alpha, but died of hepatorenal syndrome and hepatic encephalopathy 15 days later. HIV-1 cultures were positive from the recipient's blood on day 14 but not days 0, 1, and 8. At autopsy, cultures of parietal lobe isolated HIV-1. HIV-1 nucleic acid was present in several brain areas, but not in several other organs, by two independent laboratories using the polymerase chain reaction. The brain showed mild perivascular cuffing and a mild lymphocytic meningitis, but there was no evidence of glial nodules, giant cells, or white matter abnormalities. HIV-1 pg41 viral antigen was seen by immunoperoxidase staining in rare infiltrating cells within perivascular and subpial spaces. Thus, HIV-1 was isolated from brain 15 days after mistaken HIV-1 inoculation and 1 day after virus was first recovered from blood.

Breastfeeding has long been believed to protect against infection in infants, but protection against respiratory illnesses has not been consistently demonstrated in studies in developed countries. Between 1988 and 1992, the authors assessed the effect of breastfeeding on incidence and duration of respiratory illnesses during the first 6 months of life in a prospective study that actively tracked breastfeeding and respiratory illnesses. A cohort of 1,202 healthy infants, born in Albuquerque, New Mexico, between January 1, 1988 and June 30, 1990, from homes without smokers was enrolled. The daily occurrences of respiratory symptoms and breastfeeding status were reported by the mothers every 2 weeks. Illnesses were classified as lower respiratory illness (LRI) if wheezing or wet cough was reported; the remaining illnesses were classified as upper respiratory. The annualized incidence rates for LRI were 2.8, 2.6, and 2.1 during follow-up time with no, partial, or full breastfeeding, respectively, but the incidence rates for upper respiratory illness and lower respiratory illness combined were similar in the three categories. After adjustment for potential confounding factors, full breastfeeding was associated with a reduction in lower respiratory illness risk (odds ratio=0.81, 95% confidence interval 0.68-0.96). Median duration of all respiratory illnesses was 5 days for the fully breastfed infants during the first 6 months of life compared with a median of 6 days for not breastfed and partially breastfed infants. Multivariate analysis confirmed that breastfeeding significantly reduced the duration of respiratory illness. This pattern of reduced incidence of LRI and shorter duration of all respiratory illnesses suggests that breastfeeding reduces the severity of infant respiratory illnesses during the first 6 months of life.

Objectives The clinical performance of the BD Veritor™ System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Methods: Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO]), ≥18 years of age, were utilized to compare Veritor with the Lyra® SARS-CoV-2 PCR Assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO), ≥18 years of age, were utilized to compare performance of Veritor to that of the Sofia® 2 SARS Antigen FIA test (Sofia 2). Positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. Results: In study 1, PPA for Veritor, compared to Lyra, ranged from 81.8%-87.5% for 0-1 through 0-6 DSO ranges. In study 2, Veritor had a PPA, NPA, and OPA of 97.4%, 98.1%, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Conclusions: Veritor met FDA-EUA acceptance criteria for SARS-CoV-2 antigen testing (≥80% PPA point estimate) for the 0-5 and 0-6 DSO ranges. Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test allows for more rapid COVID-19 testing utilizing easy-to-collect nasal swabs, but demonstrated less than 100% PPA compared to PCR..

The spread of HCV among both HIV-infected and -uninfected MSM in the United States has been ongoing since the beginning of the HIV epidemic. In HIV-infected men with <500 CD4(+) T cells, the HCV incidence rate was inversely proportional to CD4 T-cell count.

Chronic hepatitis B (CH-B) is common among HIV-infected individuals and increases liver-related mortality in the absence of highly active antiretroviral therapy (HAART). The impact of CH-B on long-term HAART outcomes has not been fully characterized.Methods-To address this question, HAART initiators enrolled in the Multicenter AIDS Cohort Study (MACS) were retrospectively analyzed. Subjects were classified by hepatitis B category based on serology at the time of HAART initiation. The association of CH-B with mortality, AIDS defining illnesses, CD4 rise, and HIV suppression was assessed using regression analysis.

C ervical cancer is caused by persistent infection with high-risk human papillomavirus (hrHPV). The incidence of invasive cervical cancer has been significantly reduced over the past 50 years by the widespread implementation of cytology-based screening using the Papanicolaou (Pap) test (1). However, because of the limited sensitivity of a single Pap test, cervical cancer and its precursors (cervical intraepithelial neoplasia grades 2 and 3 [CIN2 and CIN3, respectively]) remain significant public health issues. The recent development of assays that allow the detection of hrHPV DNA in cervical specimens has shown them to be more sensitive than the Pap test for the detection of CIN2 and CIN3 in a single screening round (2-4). To be clinically relevant, HPV assays should be based on clinical rather than on analytic sensitivity, since only a minority of HPV-positive women progress to highgrade cervical disease. Moreover, the clinical utility of an HPV test would be enhanced if it could also identify hrHPV-positive women who are at the highest risk of having or developing highgrade disease, because doing so has the potential to improve both sensitivity and specificity. Given the recent evidence for the significantly greater oncogenic risks of HPV16 and HPV18 relative to the other hrHPV types (5-8), an HPV test capable of specifically identifying these 2 genotypes might be expected to provide additional clinical value. Moreover, all HPV tests must demonstrate analytic sensitivity, accuracy, good reproducibility, and inclusivity and exclusivity.The cobas HPV test is a fully automated real-time PCR DNA amplification test that received approval by the Food and Drug Administration in April 2011 and was developed to maximize clinical utility. The cutoff for a positive result was determined based on the ability of the assay to detect histologically confirmed high-grade cervical disease, defined as cervical intraepithelial neoplasia (CIN), grade 2 or worse (ՆCIN2), rather than on the detection of a minimum number of viral copies. The unique test design also allowed simultaneous reporting of a pooled hrHPV result in addition to individual results for HPV16 and HPV18, the 2 most-oncogenic genotypes (5-8). Here, we report details on the development and validation of the cobas HPV test with emphasis on how its design and performance contribute to the establishment of clinical utility. MATERIALS AND METHODSAssay design and conditions. The cobas HPV test is a highly automated assay for the detection of hrHPV DNA in liquid-based cytology (LBC) specimens using real-time PCR technology with a set of 16 PCR primers (8 forward and 8 reverse) that amplify a ϳ200-bp fragment of the L1 gene from all 14 hrHPV genotypes. TaqMan probes labeled with 3 spectrally unique fluorescent dyes allow for the simultaneous detection of 14 hrHPV types from 3 separate channels with real-time PCR technology. Twelve hrHPV types (HPV31, are detected as a pool in channel 1, and the hrHPV16 and HPV18 genotypes are simultaneously detected individually in channel...

Introduction The LumiraDx severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2, was evaluated for diagnosing acute coronavirus disease 2019 (COVID-19) in adults and children across point-of-care settings (NCT04557046). Methods Two paired anterior nasal swabs or two paired nasopharyngeal swabs were collected from each participant. Swabs were tested by the LumiraDx SARS-CoV-2 antigen test and compared with real-time polymerase chain reaction (rt-PCR; Roche cobas 6800 platform). Sensitivity, specificity and likelihood ratios were calculated. Results were stratified on the basis of gender, age, duration of symptoms, and rt-PCR cycle threshold. Results Out of the 512 participants, aged 0–90 years, of this prospective validation study, 414 (81%) were symptomatic for COVID-19 and 123 (24%) swabs were positive for SARS-CoV-2 based on rt-PCR testing. Compared with rt-PCR, the 12-min nasal swab test had 97.6% sensitivity and 96.6% specificity, and nasopharyngeal swab had 97.5% sensitivity and 97.7% specificity, within 12 days of symptom onset, representing the period of infectivity. All (100%) samples detected within 33 rt-PCR cycles were also identified using the antigen test. Results were consistent across age and gender. The user error rate of the test system when used by minimally trained operators was 0.7% (95% confidence interval [CI] 0.1–3.7%). Conclusion The rapid, high-sensitivity assay using nasopharyngeal or anterior nasal sampling may offer significant improvements for diagnosing acute SARS-CoV-2 infection in clinic- and community-based settings. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-021-00413-x.

Nitrogen dioxide is an oxidant gas that contaminates outdoor air and indoor air in homes with unvented gas appliances. A prospective cohort study was carried out to test the hypothesis that residential exposure to NO2 increases incidence and severity of respiratory illnesses during the first 18 months of life. A cohort of 1,205 healthy infants from homes without smokers was enrolled. The daily occurrence of respiratory symptoms and illnesses was reported by the mothers every 2 wk. Illnesses with wheezing or wet cough were classified as lower respiratory tract. Indoor NO2 concentrations were serially measured with passive samplers place in the subjects' bedrooms. In stratified analyses, illness incidence rates did not consistently increase with exposure to NO2 or stove type. In multivariate analyses that adjusted for potential confounding factors, odds ratios were not significantly elevated for current or lagged NO2 exposures, or stove type. Illness duration, a measure of illness severity, was not associated with NO2 exposure. The findings can be extended to homes with gas stoves in regions of the United States where the outdoor air is not heavily polluted by NO2.