title: Comparison of Directigen Flu A+B with Real Time PCR in the Diagnosis of Influenza.
abstract: Early diagnosis and treatment of patients with influenza is the reason why physicians need rapid high-sensitivity influenza diagnostic tests that require no complex lab equipment and can be performed and interpreted within 15 min. The Aim of this study was to compare the rapid Directigen Flu A+B test with real time PCR for detection of influenza viruses in the Republic of Macedonia.
  
  
  
  One-hundred-eight respiratory samples (combined nose and throat swabs) were routinely collected for detection of influenza virus during influenza seasons. Forty-one patients were pediatric cases and 59 were adult. Their mean age was 23 years. The patients were allocated into 6 age groups: 0-4 yrs, 5-9 yrs, 10-14 yrs, 15-19 yrs, 20-64 yrs and > 65 yrs. Each sample was tested with Directigen Flu A+B and CDC real time PCR kit for detection and typisation/subtypisation of influenza according to the lab diagnostic protocol.
  
  
  
  Directigen Flu A+B identified influenza A virus in 20 (18.5%) samples and influenza B virus in two 2 (1.9%) samples. The high specificity (100%) and PPV of Directigen Flu A+B we found in our study shows that the positive results do not need to be confirmed. The overall sensitivity of Directigen Flu A+B is 35.1% for influenza A virus and 33.0% for influenza B virus. The sensitivity for influenza A is higher among children hospitalized (45.0%) and outpatients (40.0%) versus adults.
  
  
  
  Directigen Flu A+B has relatively low sensitivity for detection of influenza viruses in combined nose and throat swabs. Negative results must be confirmed.
authors.affiliation: Institute of Public Health
authors.forename: Golubinka
authors.initials: G
authors.lastname: Bosevska
authors.affiliation: Institute of Microbiology and Parasitology, Medical Faculty, Sts. Cyril and Methodius University
authors.forename: Nikola
authors.initials: N
authors.lastname: Panovski
authors.affiliation: Institute of Public Health
authors.forename: Elizabeta
authors.initials: E
authors.lastname: Janceska
authors.affiliation: Institute of Public Health
authors.forename: Vladimir
authors.initials: V
authors.lastname: Mikik
authors.affiliation: Clinic for Infectious Diseases and Febrile Conditions, Medical Faculty, Sts. Cyril and Methodius University, Republic of Macedonia
authors.forename: Irena Kondova
authors.initials: IK
authors.lastname: Topuzovska
authors.affiliation: Clinic for Infectious Diseases and Febrile Conditions, Medical Faculty, Sts. Cyril and Methodius University, Republic of Macedonia
authors.forename: Zvonko
authors.initials: Z
authors.lastname: Milenkovik
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D009980:Influenza A virus / Q000235:genetics / Q000302:isolation & purification*; D009981:Influenza B virus / Q000235:genetics / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis*; D008875:Middle Aged; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity