ABSTRACT
Background: This case-control prospective study aimed to describe the effects of COVID convalescent plasma (CCP) therapy in patients diagnosed with coronavirus disease 2019 (COVID-19) pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, during the fourth trimester of 2020 in Venice Prefecture (North East Italy). Methods: Overall, 214 consecutive patients admitted to COVID-19 Hospitals of our district were enrolled. The confirmation of SARS-CoV-2 infection was made through the reverse transcription-polymerase chain reaction test in nasopharyngeal swabs. The severity of each patient’s clinical condition was determined following the Berlin score. The clinical data, laboratory test reports and imaging diagnosis of all patients were analyzed at hospitalization. All subjects were showing symptoms of severe COVID-19 pneumonia and were treated with conventional therapy;108 patients received standard therapy and 106 received standard therapy in combination with CCP. The endpoint was mortality at 30 days. Results: The two patient series were comparable for gender, age, risk factors, Berlin score, PaO2/FiO2. Both groups received standard therapy: NSAIDs, ventilator support, LMWH, steroids, antibiotics and antivirals;106 subjects were additionally administered CCP. The mortality rate at 30 days was 30.6% among subjects treated with standard therapy versus 30.2% among subjects treated with standard therapy plus CCP. Considering the radiological findings and ventilatory support data, it would appear that the disease was more severe in patients treated with ST plus CCP. Conclusions: This case-control prospective study showed that in a cohort of hospitalized patients suffering from severe COVID-19 pneumonia, the addition of CCP to the standard therapy did not impact the mortality rate at 30 days. However, we believe that further studies are needed to evaluate the effectiveness of convalescent plasma therapy.
ABSTRACT
Background. In this study SARS-CoV-2 serology was investigated, using two different ELISA assay, in a cohort of subjects convalescing after COVID-19 recruited for the establishment of a hyperimmune plasma bank. Methods. SARS-CoV-2 serology was investigated in 326 subjects using two commercial ELISA methods: CLIA, MAGLUMI 2019-nCoV IgG CLIA and DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG. Results. Using the MAGLUMI IgG assay 56 subjects 17% were negative and using the SORIN IgG assay 43 subjects (13%) were negative too. MAGLUMI IgG test and the SORIN IgG test showed an good agreement (Cohen's K index = 0.65). Conclusions. Among 326 subjects evaluated after a microbiologically confirmed symptomatic COVID-19 disease in a not negligible number of subject was impossible to demonstrate a humoral immune response In our experience, the MAGLUMI and SORIN tests have shown good agreement in identifying subjects with IgG antibodies to SARS-CoV-2. However, the quantitative response appears to be very little comparable. Moreover results obtained in this study further underline the need for an evaluation of the pre-analytical, analytical conditions and post-analytical and the need for better standardization and harmonization of diagnostic serological tests for SARS-CoV-2.
ABSTRACT
Background: In this study SARS-CoV-2 serology was investigated, using three different methods, in a cohort of convalescent patients from SARS-CoV-2 infection, recruited for the establishment of a hyperimmune plasma bank. Methods: SARS-CoV-2 serology was investigated in 326 subjects using three commercial methods: MAGLUMI (MAG) 2019-nCoV IgM CLIA, MAGLUMI 2019-nCoV IgG CLIA and DiaSorin (SOR) LIAISON SARS-CoV-2 S1/S2 IgG. Moreover, 143 subjects were tested using a plaque reduction micro neutralization assay. Results: MAG IgG test and SOR IgG test showed a good agreement (Cohen's K index = 0.65, CI 95% 0.55 - 0.78). Considering SOR IgG test versus micro neutralization test, the observed cut-off values were: 85 AU/mL for a neutralizing titer of 1/80;108 AU/mL for 1/160 titer and 144 AU/mL for 1/320 titer. Considering MAG IgG test versus micro neutralization test, the observed cut-off values were: 4 AU/mL for a neutralizing titer of 1/80, 5 AU/mL for 1/160 titer and 7 AU/mL for 1/320 titer. Conclusions: In our experience, the MAG and SOR tests showed good agreement in identifying subjects with IgG antibodies to SARS-CoV-2. Obtained results confirmed a good correlation between the antibody concentration detected by the SOR IgG and the neutralizing titer determined by the plaque reduction test.