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Simplexa vzv swab direct package insert

WebbThe Solana HSV 1+2/VZV Assay is a multiplex in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2), and Varicella-zoster virus (VZV) … WebbThe DiaSorin Simplexa™ Varicella Zoster Virus (VZV) Direct FDA approved assay is a rapid real-time PCR that enables the direct amplification, detection of VZV from both cutaneous and mucocutaneous swab specimens and CSF specimens. A well conserved region of the VZV DNA polymerase gene is targeted to identify VZV in the specimen.

Predicting Direct-Specimen SARS-CoV-2 Assay Performance Using …

WebbDEVICE: Simplexa™ VZV Swab Direct (20816101025712) Download: XML JSON Print Device Record History View all sections Close all sections Device Identifier (DI) Information Brand Name: Simplexa™ VZV Swab Direct Version or Model: MOL3655 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company … WebbThe Simplexa™ VZV Direct assay demonstrated high performance with excellent clinical agreement against PCR/bi-directional sequencing for CSF samples. Simplexa TM VZV … portadown to belfast airport https://thenewbargainboutique.com

May 13, 2024 - Food and Drug Administration

WebbOur Simplexa ™ VZV Swab Direct assay utilizes only 50 µl of cutaneous or mucocutaneous swab specimen. Broad coverage includes samples collected from lesion locations … Webb25 sep. 2024 · The Simplexa VZV Swab Direct assay enables direct detection of VZV DNA from both cutaneous and mucocutaneous swab specimens. It runs on DiaSorin's Liaison MDX instrument and complements its herpes simplex tests, such as the Simplexa HSV 1 & 2 Direct kit, the firm said. Webb7 jan. 2024 · Predicting Direct-Specimen SARS-CoV-2 Assay Performance Using Residual Patient Samples The Journal of Applied Laboratory Medicine Oxford Academic AbstractBackground. Diagnostic sensitivities of point-of-care SARS-CoV-2 assays depend on specimen type and population-specific viral loads. Evaluation of these portadown to belfast train

Simplexa Direct – Quick Protocol Guide - DiaSorin Molecular

Category:Comparative study of four SARS-CoV-2 Nucleic Acid

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Simplexa vzv swab direct package insert

510(k) Substantial Equivalence Determination Decision …

WebbThe Simplexa VZV Direct assay is a real-time polymerase chain reaction (PCR) system that enables the direct amplification and detection of VZV DNA from unprocessed cerebral … WebbThe Simplexa™ HSV 1 & 2 Direct kit contains reagents for 24 reactions. Each vial contains sufficient material for a single reaction. The kit contains the Reaction Mix, the …

Simplexa vzv swab direct package insert

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WebbDirect Amplification Disc. Simplexa ® Congenital CMV Direct Kit. The only FDA-cleared real-time PCR assay for the in vitro qualitative detection of cytomegalovirus (CMV) from both saliva swab and urine specimens … WebbThe Simplexa™ HSV 1/2 & VZV Universal Direct assay demonstrated greater than 98% positive percent agreement and greater than or equal to 99.0% negative percent …

WebbThe Simplexa HSV 1 & 2 Direct assay system is a real-time PCR that enables the direct amplification, detection and differentiation of HSV-1 and/or HSV-2 DNA from … WebbThe Simplexa® COVID-19 Direct has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. The test has been …

WebbThe Simplexa® COVID-19 Direct kit allows for fast results directly from nasal swab, nasopharyngeal swab, nasal wash/aspirate, and BAL specimens, eliminating traditional … WebbThe Simplexa VZV Swab Direct assay is a real-time PCR system that enables the direct amplification and detection of VZV DNA from unprocessed cutaneous and …

WebbSimplexa VZV Swab Direct, Simplexa VZV Positive Control Pack: DiaSorin Molecular LLC: K180559: HSV 1 & 2 ELITe MGB Kit; ELITe InGenius: ELITechGroup: K173798: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack: DiaSorin Molecular LLC: K162451: Solana HSV 1+2/VZV Assay: QUIDEL CORPORATION: K151906

Webb17 dec. 2024 · "With this release, we now offer a comprehensive menu of VZV and HSV tests from cerebrospinal fluid, mucocutaneous swab specimens, and cutaneous swab specimens," Michelle Tabb, chief scientific officer at DiaSorin Molecular, said in a statement. She said that customers can run all of the tests at the same time. portadown to belfast timetableWebb30 aug. 2024 · The DiaSorin Molecular Simplexa™ COVID-19 Direct assay system is a real-time RT-PCR system that en ables the direct amplification of Coronavirus SARS-CoV-2 RNA from nasopharyngeal swabs (NPS), nasal swabs (NS), nasal wash/aspirate (NW) or bronchoalveolar lavage (BAL) specimens. portadown to belfast train timetableWebbOur Simplexa ® HSV 1 & 2 Direct assay utilizes only 50 µl of sample and is cleared for BOTH CSF and mucocutaneous/cutaneous swabs. Broad coverage that includes samples collected from lesion locations … portadown to belfast international airportWebbOur Simplexa TM HSV 1 & 2 Direct assay utilizes only 50 µl of sample and is cleared for BOTH CSF and mucocutaneous/cutaneous swabs. Broad coverage that includes … portadown to dublin busWebbNeonatal surface swabs: Using a single regular flocked swab, swab conjunctivae, mouth, nasopharynx, and rectum. Break the swab into UTM and transport to the laboratory immediately. ... References: Simplexa HSV 1&2 Direct Package Insert. Rev. 04 ed. Cypress, CA: Diasorin Molecular 2024. p1-35 CLSI. portadown to cookstown busWebbDevice Classification Name. herpes virus (vzv, hsv1, hsv2), dna detection assay for cutaneous and mucocutaneous lesion samples. 22. 510 (k) Number. K192376. Device … portadown to dublin train timesWebbOur Simplexa ® VZV Swab Direct assay utilizes only 50 µl of cutaneous or mucocutaneous swab specimen. Broad coverage includes samples collected from lesion locations … portadown to belfast city airport