A validation study comparing the sensitivity and specificity of the new Dr. KSU H1N1 RT-PCR kit with real-time RT-PCR for diagnosing influenza A (H1N1)

A new test (Dr. KSU H1N1 RT-PCR kit) was recently developed to provide a less expensive alternative to real-time reverse transcriptase-polymerase chain reaction (RT-PCR). We report the findings of a validation study designed to assess the diagnostic accuracy, including sensitivity and specificity, o...

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Bibliographic Details
Published in:Annals of Saudi medicine 2011-07, Vol.31 (4), p.351-355
Main Authors: Binsaeed, Abdulaziz A, Al-Khedhairy, Abdulaziz A, Mandil, Ahmed M A, Shaikh, Shaffi A, Qureshi, Riaz, Al-Khattaf, Abdulaziz S, Habib, Hanan A, Alam, Awatif A, Al-Ansary, Lubna A, Al-Omran, Mohammed
Format: Article
Language:English
Subjects:
Adolescent
Adult
Body Temperature
Child
Child, Preschool
Confidence intervals
Cost-Benefit Analysis
Cross-Sectional Studies
Diagnosis
Female
Genomes
Health aspects
Hospitals, Teaching
Humans
Infant
Influenza A Virus, H1N1 Subtype - isolation & purification
Influenza, Human - diagnosis
Influenza, Human - virology
Male
Methods
Middle Aged
Original
Pandemics
Patients
Polymerase chain reaction
Primary Health Care
Real-Time Polymerase Chain Reaction
Reverse Transcriptase Polymerase Chain Reaction - economics
Reverse Transcriptase Polymerase Chain Reaction - methods
Saudi Arabia
Sensitivity and Specificity
Swine influenza
Time Factors
Validation studies
Young Adult
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Summary:A new test (Dr. KSU H1N1 RT-PCR kit) was recently developed to provide a less expensive alternative to real-time reverse transcriptase-polymerase chain reaction (RT-PCR). We report the findings of a validation study designed to assess the diagnostic accuracy, including sensitivity and specificity, of the new kit, as compared to real-time RT-PCR. Cross-sectional validation study conducted from 18-22 November 2009 at a primary care clinic for H1N1 at a tertiary care teaching hospital in Riyadh. Nasopharyngeal swab samples and data on socio-demographic characteristics and symptoms were collected from 186 patients. Swab samples were sent to the laboratory for testing with both real-time RT-PCR and the new Dr. KSU H1N1 RT-PCR kit. We measured the sensitivity and specificity of the new test across the entire sample size and investigated how these values were affected by patient socio-demographic characteristics and symptoms. The outcomes of the two tests were highly correlated (kappa=0.85; P
ISSN:0256-4947
0975-4466
DOI:10.4103/0256-4947.83212