The purpose of this study was to compare the diagnostic accuracy for the detection of infection between the culture of fluid obtained by sonication (SFC) and the culture of peri-implant tissues (PITC) in patients with early and delayed implant failure, and those with unsuspected and suspected septic failure. It was hypothesised that SFC increases the diagnostic accuracy for infection in delayed, but not early, implant failure, and in unsuspected septic failure. The diagnostic accuracy for infection of all consecutive implants (hardware or prostheses) that were removed for failure was compared between SFC and PITC. This prospective study included 317 patients with a mean age of 62.7 years (9 to 97). The sensitivity for detection of infection using SFC was higher than using PITC in an overall comparison (89.9% versus 67%, respectively; p < 0.001), in unsuspected septic failure (100% versus 48.5%, respectively; p < 0.001), and in delayed implant failure (88% versus 58%, respectively; p < 0.001). PITC sensitivity dropped significantly in unsuspected compared with suspected septic failure (p = 0.007), and in delayed compared with early failure (p = 0.013). There were no differences in specificity. Sonication is mainly recommended when there is implant failure with no clear signs of infection and in patients with delayed implant failure. In early failure, SFC is not superior to PITC for the diagnosis of infection and, therefore, is not recommended as a routine diagnostic test in these patients.
This cohort study assesses the concentration of SARS-CoV-2 antibodies in the breast milk of women who received vaccines for COVID-19 and their correlation with serum antibody levels.
INTRODUCTION
The recent approval of vaccines against COVID–19 has generated great concern among breastfeeding women, since these patients were excluded from vaccination clinical trials. The present study aimed to analyze the levels of specific SARS–CoV–2 antibodies in breast milk of mRNA–vaccinated women across time and their correlation with serum antibody levels.
METHODS
Prospective study including lactating women aged over 18 who were vaccinated against SARS–CoV–2 with the Pfizer–BioNTech® COVID–19 vaccine (BNT162b2). Paired serum and breast milk samples were simultaneously taken from each participant at three timepoints after receiving the vaccine: 2 weeks after 1st dose, 2 weeks after 2nd dose and 4 weeks after 2nd dose (Timepoints 1, 2 and 3, respectively). Levels of IgG antibodies against the spike protein (S1 subunit) were determined for each sample (Architect, Abbott®).
RESULTS
We collected and analyzed 52 serum and 52 milk samples from the first 18 study participants. Median (interquartile range) IgG(S1) levels for serum – milk pairs at each timepoint were 410 (208-606) – 1.7 (0-2.9) AU/ml at Timepoint 1, 11505 (8933 – 21184) – 52.2 (34.1–113) at Timepoint 2 and 8311 (5578–17419) – 41.7 (24.8–75.3) at Timepoint 3. Pearson′s correlation coefficient between breast milk and serum IgG(S1) levels was 0.71.
No major adverse reactions were observed in mothers or infants.
CONCLUSIONS
Breast milk from women vaccinated with mRNA–based Pfizer–BioNTech® vaccine contains specific anti–SARS–CoV–2 IgG(S1) antibodies, with levels increasing considerably after second dose. IgG(S1) levels in breast milk are positively correlated with corresponding serum levels.
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