scholarly journals Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays

Author(s):  
Rebeca Santano ◽  
Diana Barrios ◽  
Fàtima Crispi ◽  
Francesca Crovetto ◽  
Marta Vidal ◽  
...  

AbstractSerological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Rebeca Santano ◽  
Diana Barrios ◽  
Fàtima Crispi ◽  
Francesca Crovetto ◽  
Marta Vidal ◽  
...  

AbstractSerological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and the COVID-19 ELISA IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.


1987 ◽  
Author(s):  
W van den Berg ◽  
M Peters ◽  
C Breederveld ◽  
J W ten Cate ◽  
J G Koppe

The observation of AT III deficiency in premature neonates with Idiopathic Respiratory Distress Syndrome (IRDS), suggests a positive predictive value for a poor outcome. The underlying diffuse intravascular coagulation could generate serious hemorrhagic complications like Peri/Intraventricular Hemorrhage (IVH).A prospective study was performed in consecutively born neonates to assess the predictive value of low AT III for theoccurrence of IVH, (gr. III/IV), IRDS, and death. Eighty-one neonates were included in the study during a period of 5 months. AT III levels were determined immediately after birth by a chromogenic substrate assay. Values in umbilical cord blood were identical with values in capillary or peripheral vein blood samples taken within 6 hours after birth. There was no correlation between AT III values and gestational age (r: 0.18). Twenty-four neonates with IRDS showed a mean AT III value of 0.23 U/ml (S. D. ± 0.07 U/ml) which was significantly lower than a mean AT III value of 0.35 U/ml (S. D. ± 0.1 U/ml) for neonates without IRDS (p ≺0.00005). When IVH gr. III/IV was diagnosed in neonates having IRDS (8/24) no significant difference in mean AT IIIact was observed with respect to jnean AT III levels of remaining neonates without this complication. No death occurred in neonates without IRDS. Mean AT IIIact (0.21 U/ml) in neonates with IRDS who died (9/24) was low compared with mean AT III levels of neonates with IRDS who survived (0.25 U/ml), but did not reach significance (p≻0.1). Assuming a critical value of AT III of 20% a positive predictive value of 89% for IRDS, 44% for IVH, and 56% for death was calculated. It is concluded that low AT Illact levels have a high predictive value for IRDS.


BJS Open ◽  
2021 ◽  
Vol 5 (Supplement_1) ◽  
Author(s):  
Jacob Rapier ◽  
Steven Hornby ◽  
Jacob Rapier

Abstract Introduction The NUn score was created to try and predict the risk of anastomotic leak or major complications (using the Clavien- Dindo classification) from upper GI resections with an oesophageal anastomosis. A score of > 10 was used to predict an increased risk. In this study we attempt validation. Methods A database of 101 patients was studied, who underwent an Oesophagectomy for cancer between March 2017 and 2020. 72 patients had complete Post-operative day 4 bloods, needed to calculate the score. These patients were then studied for post-operative complications. Results A total of 12 patients had a NUn score of > 10 (16.67%). There was 1 death (1.37%) and 11 anastomotic leaks (15.28%). Of these the NUn score did not predict the death and predicted 8 of the 11 anastomotic leaks. From our data Conclusion From our analysis the NUNs score cannot be shown to be sensitive, specific or have useful positive predictive value. The average Nun score was not reliable, with confidence intervals crossing 10. There may be some merit in using the test for its negative predictive value, but further analysis into this is needed. The results of this audit are consistent with previous efforts at external validation.


2006 ◽  
Vol 95 (9) ◽  
pp. 1116-1123 ◽  
Author(s):  
Carlo Dani ◽  
Giovanna Bertini ◽  
Marco Pezzati ◽  
Luca Filippi ◽  
Alessandra Cecchi ◽  
...  

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 302
Author(s):  
Milo Gatti ◽  
Fabrizio De De Ponti

COVID-19 may lead to severe respiratory distress syndrome and high risk of death in some patients. So far (January 2021), only the antiviral remdesivir has been approved, although no significant benefits in terms of mortality and clinical improvement were recently reported. In a setting where effective and safe treatments for COVID-19 are urgently needed, drug repurposing may take advantage of the fact that the safety profile of an agent is already well known and allows rapid investigation of the efficacy of potential treatments, at lower costs and with reduced risk of failure. Furthermore, novel pharmaceutical formulations of older agents (e.g., aerosolized administration of chloroquine/hydroxychloroquine, remdesivir, heparin, pirfenidone) have been tested in order to increase pulmonary delivery and/or antiviral effects of potentially active drugs, thus overcoming pharmacokinetic issues. In our review, we will highlight the importance of the drug repurposing strategy in the context of COVID-19, including regulatory and ethical aspects, with a specific focus on novel pharmaceutical formulations and routes of administration.


PEDIATRICS ◽  
1987 ◽  
Vol 79 (6) ◽  
pp. 1005-1007
Author(s):  
Meenakshi K. Jhaveri ◽  
Savitri P. Kumar

Times of first stool passage were studied in 171 infants who weighed less than 1,500 g at birth. Delayed passage (greater than 48 hours) was noted in 20.4% of this group. Significant differences were noted between the delayed and nondelayed groups for gestational age, presence of severe respiratory distress syndrome, and the time of the first enteral feeding. In very low birth weight infants, delay in the passage of the first stool is a common occurrence. This delay is probably due to physiologic immaturity of the motor mechanisms of the gut, lack of triggering effect of enteral feeds on gut hormones, and the presence of severe respiratory distress syndrome, which may singly or in concert adversely affect gastrointestinal motility.


2006 ◽  
Vol 88 (2) ◽  
pp. 165-167 ◽  
Author(s):  
M Bradley ◽  
J Morgan ◽  
B Pentlow ◽  
A Roe

INTRODUCTION The aim of this study is to ascertain the accuracy of diagnostic ultrasound in the assessment of the occult abdominal and groin herniae. The authors have previously demonstrated its efficacy in diagnosing the type of clinical groin herniae but occult herniae provide a further diagnostic problem. PATIENTS AND METHODS A total of 113 consecutive patients were referred prospectively for ultrasound examinations with clinically suspected occult herniae. All positive scans were offered surgery whilst the negative results were offered further imaging or other diagnostic tests depending on the clinical criteria. The end point for negative scans was based on 18-month follow-up or resolution of symptoms. RESULTS Overall, 59 scans showed positive results for herniae and 56 of these had surgery. In the other three patients, two refused an operation, and one had no hernia detected at operation. In the remaining 57 scans, ultrasound offered alternative soft tissue diagnoses in 23 patients and surgical/endoscopic diagnoses accounted for a further 8 patients. CONCLUSIONS Ultrasound offered a diagnosis for the symptomology in 82 patients (70.6%) of which 59 were herniae. The positive predictive value for hernia is 98.3%. Twenty-six patients with no diagnosis or confirmation of herniae on follow-up showed symptom resolution in 22 cases, and four patients were treated by the pain clinic.


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