scholarly journals 1402Multicenter Clinical Evaluation of the Novel Alere i Strep Isothermal Nucleic Acid Amplification Test

2014 ◽  
Vol 1 (suppl_1) ◽  
pp. S369-S369
Author(s):  
Daniel Cohen ◽  
Michael Russo ◽  
Keith Vrbicky ◽  
Preeti Jaggi ◽  
William Gluckman ◽  
...  
2019 ◽  
Vol 6 (4) ◽  
pp. 1588
Author(s):  
Shashi Bala ◽  
Suresh Goyal

Background: The aim was to determine utility of Cartridge based nucleic acid amplification test (CBNAAT) in diagnosis of mycobacterium tuberculosis in children with neurotuberculosis diagnosed on the basis of clinical evaluation, CSF findings and neuroimaging.Methods: A prospective randomized controlled trial was conducted in Pediatric Department of RNT Medical College, Udaipur, Rajasthan, India from July 2017 to June 2018. Total 110 children of age group of 6 months to 18 years with the diagnosis of tubercular meningoencephalitis (TBME) on the basis of clinical evaluation, CSF examination and neuroimaging were included in the study.Results: A total 110 children were enrolled. Maximum number of cases admitted with TBME were among 1-5 years of age group (60.91%). CSF and gastric aspirate were examined by CBNAAT for MTB. 5 (4.55%) children had CBNAAT positivity in CSF. Gastric aspirate was positive among 16 (14.55%) children. None of the patient had CBNAAT positive result both in CSF and gastric aspirate.Conclusions: TBME is a major health problem in children below 5 years. Gene Xpert assay has the potential to significantly improve and escalate the diagnosis of smear-negative body fluid specimens. CBNAAT for mycobacterium tuberculosis was positive in 5 (4.55%) children from CSF and 16 (14.55%) from gastric aspirate. Negative CBNAAT should not prevent any patient with suspected features of TBME from starting anti tubercular treatment (ATT) as sensitivity of this test remains low. Final judgement to start ATT should be based on clinical, biochemical and radiological profile especially in CNS tuberculosis.


2015 ◽  
Vol 53 (7) ◽  
pp. 2258-2261 ◽  
Author(s):  
Daniel M. Cohen ◽  
Michael E. Russo ◽  
Preeti Jaggi ◽  
Jennifer Kline ◽  
William Gluckman ◽  
...  

Rapid detection of group A beta-hemolytic streptococcus (GAS) is used routinely to help diagnose and treat pharyngitis. However, available rapid antigen detection tests for GAS have relatively low sensitivity, and backup testing is recommended in children. Newer assays are more sensitive yet require excessive time for practical point-of-care use as well as laboratory personnel. The Alere i strep A test is an isothermal nucleic acid amplification test designed to offer highly sensitive results at the point of care within 8 min when performed by nonlaboratory personnel. The performance of the Alere i strep A test was evaluated in a multicenter prospective trial in a Clinical Laboratory Improvement Amendments (CLIA)-waived setting in comparison to bacterial culture in 481 children and adults. Compared to culture, the Aleri i strep A test had 96.0% sensitivity and 94.6% specificity. Discrepant results were adjudicated by PCR and found the Alere i strep A test to have 98.7% sensitivity and 98.5% specificity. Overall, the Alere i strep A test could provide a one-step, rapid, point-of-care testing method for GAS pharyngitis and obviate backup testing on negative results.


Sign in / Sign up

Export Citation Format

Share Document