Multicenter Evaluation of the Clinical Performance and the Neutralizing Antibody Activity Prediction Properties of 10 High-Throughput Serological Assays Used in Clinical Laboratories.

As the coronavirus disease 2019 (COVID-19) pandemic second wave is emerging, it is of the upmost importance to screen the population immunity in order to keep track of infected individuals. Consequently, immunoassays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with high specificity and positive predictive values are needed to obtain an accurate epidemiological picture. As more data accumulate about the immune responses and the kinetics of neutralizing-antibody (nAb) production in SARS-CoV-2-infected individuals, new applications are forecast for serological assays such as nAb activity prediction in convalescent-phase plasma from recovered patients. This multicenter study, involving six hospital centers, determined the baseline clinical performances, reproducibility, and nAb level correlations of 10 commercially available immunoassays. In addition, three lateral-flow chromatography assays were evaluated, as these devices can be used in logistically challenged areas. All assays were evaluated using the same patient panels in duplicate, thus enabling accurate comparison of the tests. Seven immunoassays examined in this study were shown to have excellent specificity (98 to 100%) and good to excellent positive predictive values (82 to 100%) when used in a low (5%)-seroprevalence setting. We observed sensitivities as low as 74% and as high as 95% at ≥15 days after symptom onset. The determination of optimized cutoff values through receiver operating characteristic (ROC) curve analyses had a significant impact on the diagnostic resolution of several enzyme immunoassays by increasing the sensitivity significantly without a large trade-off in specificity. We found that spike-based immunoassays seem to be better correlates of nAb activity. Finally, the results reported here will add to the general knowledge of the interlaboratory reproducibility of clinical performance parameters of immunoassays and provide new evidence about nAb activity prediction.

Antizona and antisperm antibodies in women with endometriosis and/or infertility.

OBJECTIVE: To measure the levels of antigamete antibodies in serum and peritoneal fluid of women with endometriosis and/or infertility. DESIGN: Antibody activity against human sperm and porcine oocytes was analyzed in selected subgroups of women. SETTING: Clinic of reproduction. PATIENT(S): Women with endometriosis and/or infertility. INTERVENTION(S): No treatment was implemented before peritoneal fluid and blood sample collection. MAIN OUTCOME MEASURE(S): Quantitative ELISA. RESULT(S): Four groups of women (n = 98) were analyzed for the presence of antizona and antisperm antibodies: infertile with endometriosis (n = 30), idiopathic infertility (n = 28), fertile with endometriosis (n = 20), and healthy fertile controls (n = 20). Antibodies were analyzed simultaneously in serum and peritoneal fluid. No statistically significant differences in antibody levels were detected in serum samples among the analyzed groups. The median values for antizona and antisperm antibodies in peritoneal fluid were significantly higher in women with idiopathic infertility than in the control group. In women with unexplained infertility, a high degree of correlation (Spearman) was found between the presence of antizona antibodies in peritoneal fluid and serum (r = 0.579). A positive predictive value of 80% was calculated for the presence of antizona antibodies (>5 ng/oocyte) in the peritoneal fluid of patients with infertility. CONCLUSION(S): Antizona antibodies locally produced in the peritoneal fluid have diagnostic value for infertility status; however, they cannot be treated as a marker or prognostic factor for minimal endometriosis and/or its treatment.

Morphology and steroidogenesis of cultured granulosa cells from endometrioidally changed ovaries.

The aim of the study was to see the function of follicular cells collected from ovaries of women suffering from endometriosis. The material was granulosa cells taken from 11 patients operated on 3rd and 4th degree of endometriosis. Antral granulosa cells were harvested from 34 medium-size (5-10 mm in diameter) follicles located on the cysts' walls or in the cysts' vicinity. Using the culture method, morphology and steroid secretion was estimated. Morphological properties of the cells in the culture did not differ significantly from that of healthy ones. All cells formed a monolayer and achieved different degrees of luteinization. Steroidogenesis of these granulosa cells was defected, particularly in the production of progesterone and testosterone.

Morphology and steroidogenesis of cultured granulosa cells obtained from ovaries of women treated with ionizing radiation.

The object of the study was the morphology and steroidogenesis of cultured granulosa cells obtained from 6 women aged 28-39 years who, because of Ib cervix carcinoma, were treated with ionizing radiation and later underwent surgery. It was observed that the granulosa cells were viable, had strong proliferative ability, and formed a monolayer on day 2 of culture. Contrary to our expectations, these cells produced larger amounts of steroids in culture than the control cells harvested from normal ovaries in late follicular phase. It was also found that the cells treated with ionizing radiation responded to exogenous gonadotropins with higher production of progesterone and estradiol than the controls. It is concluded that the increase in metabolic activity by granulosa cells from ovaries which had been indirectly affected by ionizing radiation is manifested by the stimulating influence of radiation on steroidogenesis.

Endometrial receptivity: expression of alpha3beta1, alpha4beta1 and alphaVbeta1 endometrial integrins in women with impaired fertility.

Advances in immunohistochemical methods with the specificity of poly- and monoclonal antibodies allow the description of the endometrial receptivity, which is characterized by the ability of secretion of phase specific proteins and glikoproteins by epithelial and stromal cells. We studied the differences in the expression of alpha3beta1, alpha4beta1 and alphaVbeta1 integrins in endometrium of women with recurrent miscarriages and women with unexplained infertility. The endometrial tissue was collected during hysteroscopy performed between 7th and 9th day after ovulation. The immunohistochemical evaluation of alpha3beta1, alpha4beta1 and alphaVbeta1 integrin expression was determined in all endometrial biopsies. Staining intensity of alpha3beta1 in glandular epithelium and endometrial stroma was similar in both groups. In women with recurrent miscarriages we noted a lower concentrations of the alpha4beta1 and alphaVbeta1 integrins during the midluteal phase than in women with unexplained infertility. Moreover, integrins alpha4beta1 and alphaVbeta1 were expressed more frequently in glandular epithelium and endometrial stroma of women with unexplained infertility than those of women with recurrent miscarriages. However, alphaV(2)1 staining in endometrial stroma was stronger than that of alpha4beta1. It can be concluded, that these integrins may play an important role in the implantation process.

[Evaluation of autoantibodies against oocyte theca cells in peritoneal effusion and serum of women with endometriosis]. / Ocena autoprzeciwcial przeciw oslonce przejrzystej oocytu w plynie otrzewnowym i surowicy kobiet z endometrioza.

The aim of the study was evaluation of presence of the antibodies against theca of the oocyte in peritoneal effusion and in serum in fertile and infertile women with minimal endometriosis in luteal phase of the menstrual cycle. Antibodies were measured by means of ELISA method. Median of the antibodies against theca was three-fold higher in peritoneal effusion in infertile women. No differences were stated in serum.

[Evaluation of peritoneal fluid in women with endometriosis]. / Ocena plynu otrzewnowego u kobiet z endometrioza.

An analysis of the peritoneal fluid in women with endometriosis was undertaken. Peritoneal fluid was collected during laparoscopy from the Douglas pouch. The quantity, color of the fluid as well as macrophages number, concentration and activity were assessed. Conclusion is that no one of the listed parameters of peritoneal fluid could be considered as an endometriosis marker.

[May GM-CSF influence the ability to fertilize oocytes?]. / Czy GM-CSF moze wplywac na zdolnosc do zaplodnienia oocytów?

The aim of this work was to evaluate the concentration of granulocyte-macrophage colony stimulating factor (GM-CSF), IL-1 beta IL-6 and TNF alpha in follicular fluid obtained from mature oocytes during in vitro fertilization scheme and to determine a correlation between GM-CSF concentration and the analyzed cytokines. Material consisted of 36 samples of follicular fluid which were divided into two groups: the first one--17 samples of follicular fluid obtained from follicles with successful oocyte fertilization and cleavage and the second one--19 samples of follicular fluid with unsuccessful fertilization. The concentration of GM-CSF as well as IL-6, IL-1 beta and TNF alpha in follicular fluid was evaluated by using the ELISA immunosorbent assays. The mean concentration of GM-CSF, IL-6, IL-1 beta was similar in both groups, however, the frequency of occurrence of these parameters as well as coexistence of GM-CSF with analyzed cytokines were higher in the second group i.e. in the follicular fluid with unsuccessful fertilization. We found a positive correlation between concentration of GM-CSF and IL-6 in follicular fluid of all samples. The authors suggested that activation of macrophages to an increased release of GM-CSF during disturbance of oocyte's maturation might implicate a relation between immune and endocrine systems with cytokine mediation.

[Laparoscopy in diagnosing and treating endometriosis]. / Laparoskopia w rozpoznaniu i leczeniu endometriozy.

Clinical study in 98 women with genital endometriosis was performed. In 33 patient endometriosis was treated by operative laparoscopy-electrocauterization of foci in 20 women, ovarian cyst resection in 9 and cyst extrication in 4. In 10 cases laparoscopy was followed by laparotomy. Very high correlation between endometriosis and infertility was found (71.4%). Very few patients conceived till now (28.57%). Searching in the time of laparoscopy very subtle foci of endometriosis was stressed.

[Laparoscopy in diagnosis and treatment of polycystic ovaries]. / Laparoskopia w rozpoznawaniu i leczeniu zespolu policystycznych jajników.

Value of the laparoscopy in diagnostic process and treatment of the polycystic ovaries was analysed. Authors have presented changes in the procedure which occurred after developing new technologies. The first results of the operative laparoscopy, with use of monopolar cauterization are described.

[Laparoscopy followed by laparotomy]. / Laparoskopia zakonczona laparotomia.

Authors have presented 45 clinical situations where laparoscopy was followed by laparotomy. Pre- and intraoperative diagnosis was analyzed. Dense adhesions were the most common indication to perform laparotomy (43%).

[Evaluation of fallopian tube function after microsurgical treatment]. / Ocena funkcji jajowodów po leczeniu mikrochirurgicznym.

Authors have presented long-term results of microsurgical treatment of female infertility. Operations of the abdominal ostium were successful in 28% (home taken baby), what is similar to the results presented in the literature. Poor outcome of the other types of the microsurgical operations was analysed. Comparison of the microsurgery with the different methods of the assisted medical procreation was performed (e.g. IVF-ET and GIFT), showing the advantages of the latest.

[The evaluation of IL-12 levels in peritoneal fluid and serum of women with endometriosis]. / Ocena stezenia IL-12 w plynie otrzewnowym i surowicy u kobiet z endometrioza.

We studied levels of IL-12 in peritoneal fluid and serum in patients with minimal, advanced and recurrent endometriosis compared to women without endometriotic lesions in pelvis minor. The aim of the study was to determine whether level of IL-12 detected in peritoneal fluid or serum changes with grading of severity of endometriosis. To assess IL-12 levels immunosorbent ELISA was used. There were no statistically significant differences in IL-12 levels in peritoneal fluid nor in serum in any of studied groups. There was higher concentration (without statistical significance) of IL-12 in peritoneal fluid of healthy women compared to women with endometriosis.

[Evaluation of valvular mechanisms in uterine openings using endoscopic methods]. / Ocena aparatu zastawkowego ujsc macicznych jajowodów przy uzyciu metod endoskopowych.

Endoscopic examination was made in 20 sterile women. Particular attention was drawn to the mechanism of uterine openings of the oviductus, viewed by hysteroscopy. Clinical condition end the flux of contrast via abdominal part of oviductus evaluated using laparoscopic technique. The hysteroscopic picture of valvular mechanisms is reliable element for evaluation of potency of oviductus. Combined laparoscopy and hysteroscopy brings a lot of information concerning the structure and function of oviductus.

[Microbiological flora cultured from peritoneal fluid of women in reproductive age]. / Flora mikrobiologiczna izolowana z plynu otrzewnowego u kobiet w wieku rozrodczym.

The aim of the study was to assess the presence of the microbes in peritoneal fluid of women in reproductive age. An investigation was performed on the group of 144 women operated laparoscopically in Division of Reproduction. The bacteria were cultured from 77 fluids (53.5%). The most common bacteria were: Staphylococcus epidermidis (34.1%) and Propionibacterium acnes (19.3%). In our group of patients 88 strains of bacteria were isolated. Sensitivity to antibiotics differed in many points. This situation does not allow to prepare any universal scheme of antibiotic therapy. We stress the necessity of assessing the type of bacteria and antibiotic resistance before the treatment get started. It seems to be especially important in pelvic pain syndrome and in pelvic inflammatory disease when operative procedure is necessary for bacteria isolation.

[Examination of 17 beta-estradiol and progesterone levels in peritoneal fluid and blood serum of women with endometriosis]. / Badanie stezenia 17 beta-estradiolu i progesteronu w plynie otrzewnowym i surowicy krwi kobiet z endometrioza.

Authors have presented and assessment of estradiol and progesterone levels in peritoneal fluid and blood serum in women with endometriosis. Peritoneal fluid was collected during laparoscopy performed in luteal phase of the cycle. In this cycle ovulation was controlled in all women. An ovulation was confirmed ultrasonographically and laparoscopically in 45% of women with endometriosis and in 80% of that without the illness. Progesterone concentration in peritoneal fluid in women with endometriosis was significantly lower to the control (p < 0.01).

[Hysteroscopic evaluation of the uterine tubal opening]. / Histeroskopowa ocena ujsc macicznych jajowodów.

The hysteroscopic evaluation of uterine openings in 23 sterile women was described. The attention was paid to morphological features of obliterated uterine openings. The hysteroscopic examination of structural changes located in uterine openings seems to be a reliable method for evaluation of potency of oviducts. This procedure may help in choosing the proper way of therapy--microsurgery or IVF.

[Comparison of the frequency of selected gynecologic operations conducted as laparotomy and laparoscopy during 1993-1997]. / Porównanie czestosci przeprowadzania wybranych typow operacji ginekologicznych na drodze laparotomii i laparoskopii w latach 1993-1997.

UNLABELLED: The aim of the study was to compare frequency of four gynecological operations: myomectomy, tubal surgery, cystectomy and operative management of ectopic pregnancy, performed by laparotomy or laparoscopy, by the same team of surgeons. In the years 1994-1997 in Division of Reproduction Poznan University Medical School 647 cystectomies, 208 myomectomies, 68 tuboplasties and 50 surgical treatments of ectopic pregnancy were done. Among 973 operations--684 (70.3%) were performed by laparoscopy. There was a gradual tendency in increasing endoscopic procedures. Comparing the year 1994 and 1997 percentage of operations performed by laparoscopy significantly changed: In tuboplasty from 83% to 95%, cystectomy from 35.9% to 80.3%, ectopic pregnancy from 61.5% to 91.7% and myomectomy from 52.7% to 61.5%. Patient hospital stay decreased significantly after laparoscopic procedures (from 5.1 days to 3.25 days). During the study period open surgery followed laparoscopy only in 8 cases (1.1%) because of complications or technical difficulties. CONCLUSION: 1. Operative laparoscopy is a safe and effective procedure, in many cases replacing open surgery. 2. Shortening of hospital stay and recovery period after laparoscopy is one of the main advantages of this method of treatment.

[Laparoscopic myomectomy]. / Laparoskopowe leczenie miesniaków macicy.

OBJECTIVES: The aim of our study was clinical analysis of the factors influencing on laparoscopic myomectomy. STUDY DESIGN: Retrospective analysis of the operative protocols. MATERIAL AND METHODS: Two hundred nineteen women had laparoscopy because of unexplained infertility (n = 109) unexplained infertility and myomas (n = 41), myomas (n = 36), endometriosis suspicion (n = 20) ovarian cyst (n = 9) or pelvic pain syndrome (n = 4). RESULTS: Among 299 myomas 186 were extirpated during laparoscopy. In 39 cases suturing of the myometrium was necessary. Electrocautery was performed in 27 cases and laser-vaporisation in 8. In 28 women the operation was postponed because of small myomas and mainly poor operative technique (beginning of the learning curve). In two of them second laparoscopy was performed after GnRH therapy. An analysis of the factors which enable laparoscopic myomectomy was performed. The most important factors are: size and number of the myomas, localization in the myometrium, experienced hands and operative room equipment. CONCLUSIONS: Uterine myomas are one of the indications to operative laparoscopy. Meticulous analysis of the operative conditions as well as the assessment of the team experience should always precede laparoscopy.