jan
21
2013

[Nicox] AdenoPlus à la une du très célèbre et très suivi journal JAMA (The Journal of the American Medical Association)

Une étude publiée ce mois-ci dans le très célèbre et très suivi journal JAMA (The Journal of the American Medical Association) confirme l’efficacité du test oculaire d’Adenoplus et le gain de temps et d’argent qu’il permet d’économiser par un diagnostic précis et rapide.

Pour rappel, en juin 2012, NicOx S.A. et Rapid Pathogen Screening, Inc (RPS®) ont conclu un accord de licence donnant à NicOx l’accès aux tests diagnostiques innovants de RPS®. Par cet accord, NicOx obtient les droits mondiaux de tests uniques réalisables en cabinet de consultation, dans le domaine oculaire.

Après une publication « Papier » auprès de nombreux spécialistes internationaux de l’ophtalmologie, l’article de cette étude est depuis quelques jours consultable depuis la page d’accueil du site JAMA (cf ci-dessous).

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Accès direct => Sensitivity and Specificity of the AdenoPlus Test for Diagnosing Adenoviral Conjunctivitis
Équipe projet : Robert Sambursky, MD; William Trattler, MD; Shachar Tauber, MD; Christopher Starr, MD; Murray Friedberg, MD; Thomas Boland, MD; Marguerite McDonald, MD; Michael DellaVecchia, MD, PhD; Jodi Luchs, MD

Des chercheurs (cf ci-dessus) de la clinique des yeux de Manatee Sarasota en Floride, dirigés par Robert Sambursky (Spécialiste de la cornée, de la cataracte et de la chirurgie laser) ont comparés Adenoplus aux tests traditionnels existants.

Résumé de cette étude / Source : http://www.medscape.com/viewarticle/777710 :

« The first article, evaluates the adenovirus test (AdenoPlus, Rapid Pathogen Screening Inc), which detects the most common cause of viral conjunctivitis. Adenovirus-associated conjunctivitis may lead to significant ocular morbidity and is associated with substantial healthcare costs.

Researchers led by Robert Sambursky, MD, a cornea specialist at the Manatee Sarasota Eye Clinic and Laser Center in Sarasota, Florida, compared this recently US Food and Drug Administration–cleared second-generation test with traditional gold standard tests.

« Ophthalmologists and optometrists that have access to a slit lamp biomicroscope and who should be the experts are somewhere between 25% to 60% accurate at making a differentiation between a viral and bacterial disease…and that impacts treatment, » Dr. Sambursky told Medscape Medical News.

For the multicenter trial, the researchers recruited 128 patients (76 females, 52 males) with a clinical diagnosis of acute viral conjunctivitis in a prospective, sequential manner within 7 days of developing a red eye. Patients ranged in age from 5 to 90 years, with a mean duration of symptoms among patients from each center of between 2.8 and 3.7 days.

Tear samples were collected with the test device as well as for testing by viral cell culture with confirmatory immunofluorescence assay (CC-IFA) and for polymerase chain reaction (PCR). If either CC-IFA or PCR were positive, the patient was considered definitively positive for adenoviral conjunctivitis. If both were negative, the patient was considered negative for adenoviral infection. The AdenoPlus test, which requires only 10 minutes to develop after sample collection, was read by an independent healthcare professional masked to the clinical examination results.

High Sensitivity and Specificity

Of the 128 patients, 36 were positive by either CC-IFA or PCR. Cell culture has been the traditional definitive test for adenovirus infection. « Compared to [that] gold standard, AdenoPlus has a 90% sensitivity and a 96% specificity, » Dr. Sambursky said. « When you actually compare it to PCR, that specificity goes up to about 98% and still maintains a good sensitivity in the mid-80s. » Compared with CC-IFA, the test had a positive predictive value of 88% and a negative predictive value of 97%. Compared with PCR, the positive predictive value was 94% and the negative predictive value was 95%.

« [T]he rapidity is a major advantage » of the new test, Dr. Sambursky said. Making a diagnosis early allows withholding inappropriate antibiotics from patients with viral disease instead of treating them empirically, thereby reducing the potential for developing antibiotic resistance, complications, and toxicities. « [N]ot treating is as important as treating effectively, » he noted.

Stephanie Marioneaux, MD, a cornea specialist in private practice in Chesapeake, Virginia, and an expert spokesperson from the American Academy of Ophthalmology, commended the trial for comparing AdenoPlus with the gold standard tests, which « are so burdensome, and they are not readily available to your average clinician, » she told Medscape Medical News. « [W]hereas this now makes the test much more widely accessible. » She noted that the researchers used appropriate patient eligibility criteria, a wide age range of patients, and masked examiners.

Dr. Marioneaux said the test « will add a lot to the clinician’s ability to rapidly diagnose something that is extremely contagious and is often very difficult to diagnose. » Getting infected patients out of the office quickly is an advantage, she said, because the virus is highly contagious and can persist on surfaces for weeks. »

Découvrir JAMA (The Journal of the American Medical Association) : About JAMA Ophthalmology

cox-18012013

La tendance à CT et MT reste haussière. Le repositionnement stratégique dans le domaine de l’ophtalmologie devrait commencer à porter ses fruits dans les mois à venir. A noter également que NICOX sera présent à la 15ème « BIO CEO & Investor Conference » qui se déroulera les 11-12 février 2013 à New-York.

A relire également : Nicox, en 2013 il faudra compter sur AdenoPlus !




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