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Arch Pathol Lab Med ; 146(6): 677-685, 2022 06 01.
Article in English | MEDLINE | ID: covidwho-1705033

ABSTRACT

CONTEXT.­: Moderna (mRNA-1272) and Pfizer (BNT162b2) SARS-CoV-2 vaccines demonstrate favorable safety and efficacy profiles, but direct comparison data are lacking. OBJECTIVE.­: To determine the vaccines' side effect profiles and expected antibody responses. These data may help personalize vaccine selection and identify individuals with a suboptimal vaccine response. DESIGN.­: One hundred forty-nine healthy, largely seronegative adults were assigned Moderna (n = 79) or Pfizer (n = 70). Following the second dose, participants completed a survey documenting their side effects. Serum was collected 0 to 4 days prior to dose 2, and 14 ± 4 days, 30 ± 4 days, 90 ± 10 days, and 180 ± 20 days after dose 2. Convalescent serum specimens were collected 32 to 54 days from donors after a polymerase chain reaction-confirmed SARS-CoV-2 infection (n = 20). Anti-spike antibodies were measured using the Roche Diagnostics Elecys Anti-SARS-CoV-2 S assay on a Roche cobas e801 instrument. RESULTS.­: Participants receiving the Moderna vaccine experienced side effects with greater frequency and severity. Both vaccines elicited a robust antibody response, but median signal was higher in Moderna recipients. Symptom severity decreased with age. Antibody response in Pfizer recipients negatively correlated with age. Antibody response decreased after 6 months (84% reduction in Moderna, 79% Pfizer), but values remained greater than for convalescent donors. Antibody response did not correlate with gender or symptom severity. CONCLUSIONS.­: Moderna may be preferred in individuals in need of greater immune stimulation (eg, older individuals), whereas Pfizer may be preferred in those concerned about vaccine reactions. Anti-spike antibody signal varies by vaccine, so specific reference intervals will be needed to identify individuals with a suboptimal response.


Subject(s)
COVID-19 Vaccines , COVID-19 , Adult , Antibodies, Viral , Antibody Formation , BNT162 Vaccine , COVID-19/prevention & control , COVID-19/therapy , COVID-19 Vaccines/adverse effects , Humans , Immunization, Passive , SARS-CoV-2 , COVID-19 Serotherapy
2.
J Appl Lab Med ; 6(2): 429-440, 2021 03 01.
Article in English | MEDLINE | ID: covidwho-795206

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel member of the coronavirus family that caused the global coronavirus 2019 (COVID-19) pandemic. The prevalence remains largely unknown because of early testing supply shortages. Although it cannot currently be used to determine level of immunity, antibody testing can contribute to epidemiological studies, identify convalescent plasma donors, or satisfy curiosity about previous exposure to the virus. METHODS: 407 samples collected from hospitalized inpatients with and without a confirmed SARS-CoV-2 infection, 170 remnant clinical specimens collected and frozen prior to the COVID-19 outbreak, and paired serum and plasma samples from 23 convalescent plasma donors were used to determine performance characteristics of the Abbott SARS-CoV-2 IgG and Roche Elecsys Anti-SARS-CoV-2 assays. The sensitivity, specificity, imprecision, interferences, and sample stability were determined. These assays were then used to characterize the antibody response in serial samples from 20 SARS-CoV-2 positive inpatients. RESULTS: Both assays exhibited 100% specificity (95% CI; 99.05-100.00), giving no positive results in 170 specimens collected before July 2019 and 215 specimens from patients without a confirmed SARS-CoV-2 infection. Differences between platforms were most notable in SARS-CoV-2 positive samples. Roche offered higher sensitivity in convalescent plasma donors at 95.7% (95% CI; 78.1-99.9) versus 91.3% (95% CI; 72.0-98.9) but Abbott detected antibodies in 2 immunocompromised patients whereas Roche did not. The Roche and Abbott platforms also exhibited different trends in antibody signal for a subset of patients. CONCLUSIONS: Both the Abbott and Roche platforms offer excellent specificity but different trends in antibody signal may reflect qualitative differences in the types of antibodies recognized by the 2 assays. Negative serologic results do not exclude previous SARS-CoV-2 infection.


Subject(s)
COVID-19 Serological Testing/instrumentation , COVID-19/diagnosis , Reagent Kits, Diagnostic , SARS-CoV-2/isolation & purification , Antibodies, Viral/blood , Antibodies, Viral/immunology , Antibodies, Viral/isolation & purification , COVID-19/blood , COVID-19/immunology , COVID-19/virology , Humans , Nucleocapsid/immunology , SARS-CoV-2/immunology , Sensitivity and Specificity , Seroconversion
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