Accurate Detection of <i>Streptococcus pyogenes</i> at the Point of Care Using the cobas Liat Strep A Nucleic Acid Test

Wang, Fangnian; Tian, Yinbao; Chen, Lingjun; Luo, Robert; Sickler, Joanna; O, Liesenfeld; Chen, Shuqi

doi:10.1177/0009922816684602

Cited by 41 publications

(25 citation statements)

References 17 publications

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“…Culture was used as the gold standard of comparison, with RT-PCR also being performed for adjudication in cases where the results of all 3 tests (Alere i, BD Veritor, culture) did not agree. While other studies comparing molecular POCT methods to a mixed group of rapid antigen tests, culture (12), and a lab-developed test (13) and Alere i to culture (14) have been performed, to our knowledge, this is the first study comparing Alere i and a rapid antigen test head-to-head and analyzing the hypothetical impact on antibiotic utilization based on the test results.…”

Section: Discussionmentioning

confidence: 99%

Comparison of the Alere i Strep A Test and the BD Veritor System in the Detection of Group A Streptococcus and the Hypothetical Impact of Results on Antibiotic Utilization

et al. 2018

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Rapid detection of group A (GAS) is an integral component of treatment decisions in the clinic, especially in the pediatric population. We prospectively collected 216 specimens from symptomatic, predominantly pediatric patients and evaluated the performance of the Alere i Strep A test (Alere i; Alere Inc., Scarborough, ME) and the BD Veritor system (BD Veritor; Becton, Dickinson and Company, Sparks, MD), with culture results being used as a comparator. Real-time PCR (RT-PCR) was performed as an arbiter in discordant cases. Comprehensive chart review was also done to determine the hypothetical impact of the results on antibiotic use. Alere i had a sensitivity and a specificity of 100% and 91.3%, respectively, and BD Veritor had a sensitivity and a specificity of 76.2% and 93.6%, respectively, when the results were compared to those of GAS culture. Further analysis of discordant results using RT-PCR revealed that while BD Veritor missed 13 confirmed positive cases, Alere i detected 100% ( = 13) of the same cases. Analysis of assay agreement showed that Alere i and BD Veritor had only moderate agreement (agreement = 0.888 [95% confidence interval {CI}, 0.838 to 0.927]; kappa index = 0.689 [95% CI, 0.91 to 0.974]). We also found both the underutilization and the overutilization of antibiotics based on the results of molecular testing. Overall, Alere i showed superior performance over BD Veritor in the detection of GAS pharyngitis and could potentially assist in better antibiotic utilization.

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Section: Discussionmentioning

confidence: 99%

Comparison of the Alere i Strep A Test and the BD Veritor System in the Detection of Group A Streptococcus and the Hypothetical Impact of Results on Antibiotic Utilization

et al. 2018

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“…Similarly, the role of gram-negative bacteria should be investigated. The role of rapid detection systems for Group A Streptococcus has been validated (Gazzano et al, 2016;Hudson, Theron, Roditi, & Bloch, 1991;Wang et al, 2017) and we feel there could be a role for such kits in cleft palate surgery.…”

Section: Discussionmentioning

confidence: 96%

The spectrum of intraoral bacteria seen in patients with cleft palates in an African setting

Ramdial

Madaree

2018

MicrobiologyOpen

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Dehiscence or palatal fistula formation following palatoplasty is a complication that has grave consequences for the patient that include tissue loss, emotional distress to the parents and patient, and further medical costs. Palatal dehiscence or fistula formation is multifactorial following surgery-tension of wound closure, poor patient adherence to postoperative orders and wound infection are the most common causes for this. Oral colonization with pathogenic organisms could play a role in wound healing complications. Identification of intraoral bacteria among patients with cleft palates has thus far not been performed. To identify the spectrum of intraoral bacteria in cleft palate patients in an African setting; a retrospective, chart review was performed at Inkosi Albert Luthuli Central Hospital-a quaternary hospital in Durban, South Africa. All patients with unrepaired cleft palates who underwent palatoplasty in 2015 were included. Fifty-two patients were included. Preoperative throat/palatal swabs were taken prior to palatoplasty. The various bacteria cultured from the aforementioned swabs were cataloged. Various bacteria were cultured. In total, 23 patients (44.2%) had positive swab cultures. Eighteen cultures (34.6%) had gram-positive growth only, four cultures (7.7%) had gram-negative growth only, while one patient (1.9%) cultured both a gram-positive and a gram-negative organism. Streptococcus viridans was the most commonly cultured organism (19.2%) while beta-hemolytic streptococci were cultured from only 4 swabs (7.7%). Our study cataloged the commonly occurring bacteria found in unrepaired cleft palate patients in Africa. Further research into the clinical significance of each bacteria is advised.

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“…tantly, these tests have shown similar analytical sensitivity and specificity to routine NAATs performed in central clinical laboratories (1,5,6).…”

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confidence: 81%

Assessment of Test Performance and Potential for Environmental Contamination Associated with a Point-of-Care Molecular Assay for Group A Streptococcus in an End User Setting

et al. 2019

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Although U.S. Food and Drug Administration-approved and CLIA-waived point-of-care (POC) molecular systems are being implemented in routine clinical practice, instrument reliability, test performance in the hands of end users, and the potential for environmental contamination resulting from use of POC molecular systems have not been extensively evaluated. We performed a prospective evaluation of the Roche cobas Liat group A streptococcus (GAS) assay compared to routine real-time PCR. We evaluated test accuracy, instrument failure rate, and monitored for environmental contamination when testing was performed by minimally trained end users in an Express Care Clinic environment. The overall concordance of the Liat GAS assay with routine testing was 97.2% (455/468). The average Liat failure rate across three analyzers was 6.6% (33/501) (range, 3.7 to 11.6%), and no environmental contamination was detected during the course of the study. The cobas Liat platform and GAS assay demonstrated reliable performance in the end user setting and may serve as a rapid, POC option for routine diagnostic testing for certain infectious diseases, including GAS.

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Accurate Detection of Streptococcus pyogenes at the Point of Care Using the cobas Liat Strep A Nucleic Acid Test

Cited by 41 publications

References 17 publications

Comparison of the Alere i Strep A Test and the BD Veritor System in the Detection of Group A Streptococcus and the Hypothetical Impact of Results on Antibiotic Utilization

Comparison of the Alere i Strep A Test and the BD Veritor System in the Detection of Group A Streptococcus and the Hypothetical Impact of Results on Antibiotic Utilization

The spectrum of intraoral bacteria seen in patients with cleft palates in an African setting

Assessment of Test Performance and Potential for Environmental Contamination Associated with a Point-of-Care Molecular Assay for Group A Streptococcus in an End User Setting

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