Implementation and Performance of a Point-of-Care COVID-19 Test Program in 4,000 California Schools.

OBJECTIVE: To evaluate the feasibility and accuracy of an unprecedented COVID-19 antigen testing program in schools, which required a healthcare provider order, laboratory director, a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, as well as training of school personnel. STUDY DESIGN: Descriptive report of a point-of-care, school-based antigen testing program in California from 8/1/2021 through 5/30/2022, in which participants grades K-12 self-swabbed and school personnel performed testing. Participants included 944,009 students, personnel, and community members from 4,022 California K-12 schools. Outcomes measured include sensitivity and specificity (with polymerase chain reaction [PCR] as comparator), of the Abbott BinaxNOW™ antigen test, number of tests performed, and active infections identified. RESULTS: Of 102,022 paired PCR/antigen tests, the overall sensitivity and specificity for the antigen test was 81.2% (95%CI:80.5%-81.8%) and 99.6% (95%CI:99.5%-99.6%), respectively using cycle threshold (Ct) values <30. During January through March 2022, the highest prevalence period, the positive predictive value (PPV) of antigen testing was 94.7% and the negative predictive value was 94.2%. Overall, 4,022 school sites were enrolled and 3,987,840 million antigen tests were performed on 944,009 individuals. A total of 162,927 positive antigen tests were reported in 135,163 individuals (14.3% of persons tested). CONCLUSIONS: Rapidly implementing a school-based testing program in thousands of schools is feasible. Self-swabbing and testing by school personnel can yield accurate results. On-site COVID-19 testing is no longer necessary in schools, but this model provides a framework for future infectious disease threats.

Comparing visual inspection methods for parenteral products in hospital pharmacy: between reliability, cost, and operator formation considerations.

INTRODUCTION: The COVID-19 pandemic has led to unforeseen and novel manifestations, as illustrated by the management of drug shortages through the development of hospital production of sterile pharmaceutical preparations (P2S). Visual inspection of P2S is a release control whose methods are described in monographs of the European Pharmacopoeia (2.9.20) and the United States Pharmacopeia (1790). However, these non-automated visual methods require training and proficiency testing of personnel. The main objective of this work was to compare the reliability and speed of analysis of two visual methods and an automated method for detecting visible particles by image analysis in P2S. Furthermore, these methods were used to evaluate sources of particulate contamination during pre-production processes (washing, disinfection, depyrogenation) and production (filling, capping). MATERIALS AND METHODS: Three pharmacy technicians examined 41 clear glass vials of type I, 10 and/or 50 mL through manual visual inspection (MVI), semi-automated (SAVI), and automated (AVI) inspection. The vials were distributed as follows: (i) 16 vials of water for injection containing either glass particles (224 µm or 600 µm), stopper fragments, or textile fibres; (ii) five sterile injectable specialties; (iii) 20 vials of water for injection prepared under different pre-production conditions. RESULTS AND DISCUSSION: MVI and SAVI detected 100% of visible particles compared with 28% for AVI, which showed a deficiency in detecting textile fibres. All three methods correctly analysed P2S that did not contain visible particles. The three methods detected particles in vials maintained under International Organization for Standardization (ISO) 9 pre-production conditions. However, detections by (i) MVI and SAVI, and by (ii) AVI of particles contained in vials maintained under ISO 8 pre-production conditions were deemed satisfactory and unsatisfactory, respectively. CONCLUSION: The importance of visual inspection of P2S requires rapid, sensitive, and reliable detection methods. In this context, MVI and SAVI have proven to be more effective than AVI for a more competitive financial, training, and implementation investment.

Predictive stability, novel HPLC-MS analysis and semi-automatic compounding process for the emergency implementation of a production line of pancuronium in injectable solution.

During the early months of the COVID-19 pandemic, the international medical product supply chain was tight, causing breaks in the availability of neuromuscular blocking agents essential for the treatment of patients in intensive care units. The present study describes the pharmaceutical development of an injectable 2 mg/mL solution of pancuronium bromide (PC) in a very short lapse of time. The sterile solution was compounded into a good manufacturing practice grade A clean room, filtered (0.2 µm) and filled into 10 mL type I glass, manually sealed with bromobutyl rubber stoppers. A novel HPLC-MS stability indicating method for pancuronium quantification and its degradation product was developed and validated. This fast, sensitive and straightforward method was used to study the stability of the formulation using a semi-predictive method, enabling a very fast attribution of a temporary shelf-life, which was confirmed by a classic prospective stability study. The production line and the analytical tools set-up were performed in six weeks and the semi-predictive stability study was conducted in 90 days, allowing us to predict a shelf life, which was successfully confirmed by prospective study. In conclusion, using innovative methods, we were able to rapidly overcome the shortage of a critical drug.

Lessons Learned From a COVID-19 Dog Screening Pilot in California K-12 Schools.

This diagnostic study describes a dog screening program used to identify COVID-19 infections among schoolchildren.

Multisystem Inflammatory Syndrome in Infants <12 months of Age, United States, May 2020-January 2021.

BACKGROUND: Multisystem inflammatory syndrome in children (MIS-C), temporally associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been identified in infants <12 months old. Clinical characteristics and follow-up data of MIS-C in infants have not been well described. We sought to describe the clinical course, laboratory findings, therapeutics and outcomes among infants diagnosed with MIS-C. METHODS: Infants of age <12 months with MIS-C were identified by reports to the CDC's MIS-C national surveillance system. Data were obtained on clinical signs and symptoms, complications, treatment, laboratory and imaging findings, and diagnostic SARS-CoV-2 testing. Jurisdictions that reported 2 or more infants were approached to participate in evaluation of outcomes of MIS-C. RESULTS: Eighty-five infants with MIS-C were identified and 83 (97.6%) tested positive for SARS-CoV-2 infection; median age was 7.7 months. Rash (62.4%), diarrhea (55.3%) and vomiting (55.3%) were the most common signs and symptoms reported. Other clinical findings included hypotension (21.2%), pneumonia (21.2%) and coronary artery dilatation or aneurysm (13.9%). Laboratory abnormalities included elevated C-reactive protein, ferritin, d-dimer and fibrinogen. Twenty-three infants had follow-up data; 3 of the 14 patients who received a follow-up echocardiogram had cardiac abnormalities during or after hospitalization. Nine infants had elevated inflammatory markers up to 98 days postdischarge. One infant (1.2%) died after experiencing multisystem organ failure secondary to MIS-C. CONCLUSIONS: Infants appear to have a milder course of MIS-C than older children with resolution of their illness after hospital discharge. The full clinical picture of MIS-C across the pediatric age spectrum is evolving.

Hepatitis C virus infection and spontaneous clearance in HTLV-1 and HIV co-infected patients in Salvador, Bahia, Brazil

ABSTRACTBACKGROUND: While 20-40% of patients with hepatitis C virus (HCV) monoinfection will spontaneously clear the virus, less is known regarding clearance with coinfections. HCV, human immunodeficiency virus (HIV), and human T-cell lymphotrophic virus 1 and 2 (HTLV-1/2) coinfection occurs due to shared routes of transmission and is prevalent in Brazil.OBJECTIVES:To compare the proportion of patients who have spontaneously cleared HCV in patients with HCV monoinfection to patients coinfected by HCV/HIV, or HCV/HIV/HTLV-1.METHODS:Using medical records from two clinics in Salvador, Brazil, including demographic data and serological markers of HCV, HIV and HTLV-I/II, cross-sectional data was obtained from 197 patients. Patients who were anti-HCV positive and HCV RNA negative, and who did not receive HCV treatment were defined as having cleared infection.RESULTS:Nineteen patients (9.5%) showed evidence of spontaneous HCV clearance; with clearance in 9 of 108 (8.3%) patients in the HCV monoinfected group, 5 of 68 (7.4%) patients with HCV/HIV, and 5 of 21 (23.8%) patients with HCV/HIV/HTLV. Demographic data were not associated with HCV clearance status. Patients coinfected with both HIV and HTLV-1 had increased odds (5.50; 95% CI 1.00, 30.17) of spontaneous clearance of HCV compared with patients who were HIV negative or of unknown HIV status.CONCLUSION:Our study found that patients coinfected with HIV and HTLV-1 were more likely to spontaneously clear hepatitis C virus than patients with HIV/HCV or HCV alone. The effects of HTLV coinfection on the immune response of such patients may be associated with these findings.

Hepatitis C virus infection and spontaneous clearance in HTLV-1 and HIV co-infected patients in Salvador, Bahia, Brazil.

BACKGROUND: While 20-40% of patients with hepatitis C virus (HCV) monoinfection will spontaneously clear the virus, less is known regarding clearance with coinfections. HCV, human immunodeficiency virus (HIV), and human T-cell lymphotrophic virus 1 and 2 (HTLV-1/2) coinfection occurs due to shared routes of transmission and is prevalent in Brazil. OBJECTIVES: To compare the proportion of patients who have spontaneously cleared HCV in patients with HCV monoinfection to patients coinfected by HCV/HIV, or HCV/HIV/HTLV-1. METHODS: Using medical records from two clinics in Salvador, Brazil, including demographic data and serological markers of HCV, HIV and HTLV-I/II, cross-sectional data was obtained from 197 patients. Patients who were anti-HCV positive and HCV RNA negative, and who did not receive HCV treatment were defined as having cleared infection. RESULTS: Nineteen patients (9.5%) showed evidence of spontaneous HCV clearance; with clearance in 9 of 108 (8.3%) patients in the HCV monoinfected group, 5 of 68 (7.4%) patients with HCV/HIV, and 5 of 21 (23.8%) patients with HCV/HIV/HTLV. Demographic data were not associated with HCV clearance status. Patients coinfected with both HIV and HTLV-1 had increased odds (5.50; 95% CI 1.00, 30.17) of spontaneous clearance of HCV compared with patients who were HIV negative or of unknown HIV status. CONCLUSION: Our study found that patients coinfected with HIV and HTLV-1 were more likely to spontaneously clear hepatitis C virus than patients with HIV/HCV or HCV alone. The effects of HTLV coinfection on the immune response of such patients may be associated with these findings.

Hazardous alcohol consumption among young adult IDU and its association with high risk behaviors.

BACKGROUND: Heavy alcohol consumption has been associated with risk-taking behaviors in intravenous drug users (IDU). However, limited information exists on the relationship between alcohol use and injecting and sexual risk in young adult IDU (<30 years) who are at risk for hepatitis C virus (HCV) and HIV infection. METHODS: We conducted a cross-sectional study of young adult IDU in San Francisco (2006-2012) who had not previously tested positive for HCV. Participants completed a structured interview and HCV testing. We examined whether hazardous drinking (Alcohol Use Disorders Test-Consumption [AUDIT-C] 3-9 for women and 4-9 for men) and probable dependent drinking (AUDIT-C 10-12) levels were associated with injecting and sexual risk behaviors and HCV status, indicated by adjusted odds ratios (AOR) in separate models controlling for potential confounders. RESULTS: Of the 326 participants, 139 (42.6%) were hazardous drinkers and 82 (25.2%) were probable dependent drinkers; thus over two-thirds evidenced problem drinking. Being a hazardous drinker was significantly associated with injecting drug residue from another's drug preparation equipment (AOR 1.93). Probable dependent drinking was significantly associated with sharing non-sterile drug preparation equipment (AOR 2.59), and inversely, with daily/near daily injecting (AOR 0.42). Both heavy drinking levels were associated with having ≥2 sexual partners (AOR 2.43 and 2.14). Drinking category was not associated with HCV test results. CONCLUSION: The young adult IDU reported consuming alcohol at very high levels, which was associated with some unsafe sexual and injecting behaviors. Our study demonstrates the urgent need to intervene to reduce alcohol consumption in this population.

The impact of human T-cell lymphotropic virus I infection on clinical and immunologic outcomes in patients coinfected with HIV and hepatitis C virus.

BACKGROUND: HIV, hepatitis C (HCV), and human T-cell lymphotropic virus I (HTLV-1) are associated with high global burdens of disease, notably in resource-poor locales. They share similar routes of transmission and cause chronic infections with associated morbidity. We performed a cross-sectional study to assess the impact of HTLV-1 infection on clinical outcomes in HIV/HCV-coinfected patients. METHODS: We enrolled 102 (72.3%) with HIV/HCV coinfection (Group 1) and 39 (27.7%) triply infected with HIV, HCV, and HTLV-1 (Group 2). We reviewed medical records of two groups of patients followed in two outpatients services in Salvador, Brazil. We collected and compared demographic, behavioral-related information, immunologic, virologic, and histologic parameters for HIV-1 and HCV infection. RESULTS: Demographics, virologic, and immunologic characteristics were similar in the two groups; a higher proportion of triply infected patients (Group 2) reported any history of injection drug use compared with dually infected (Group 1) patients (75% vs 45.8%; P = 0.003). No differences were seen between groups in HIV clinical outcomes (CD4 count and viral load). Alanine aminotransferase levels were significantly higher in HIV/HCV-coinfected patients (P = 0.045). Liver fibrosis damage based on Metavir scores was similar between groups (0.97) but was worse with lower CD4 cell count (under 200 cells/mm) (P = 0.01). CONCLUSIONS: HIV/HTLV-1 and HIV/HCV coinfections may worsen clinical related outcomes, but virologic and immunologic outcomes were similar in both groups. Hepatic measures were worse in patients with more severe immunosuppression.