title: Molecular detection of Mycobacterium tuberculosis from sputum transported in PrimeStore(®) from rural settings.
abstract: METHODS
  Mopani District, South Africa.
  
  
  OBJECTIVE
  To explore remote, molecular detection of Mycobacterium tuberculosis from sputum transported using PrimeStore(®) Molecular Transport Medium (PS-MTM) compared to settings where microscopy or Xpert(®) MTB/RIF is used as the baseline test.
  
  
  METHODS
  Two sputum specimens were collected from patients with cough of ⩾ 2 weeks at clinics in rural South Africa. Shortly after expectoration and before processing using Xpert, microscopy and liquid culture, a flocked swab was swirled in each of these specimens and placed in PS-MTM. Swabs were stored and transported to the United States at ambient temperature for real-time PrimeMix(®) polymerase chain reaction (PM-PCR).
  
  
  RESULTS
  Of 132 patients, 23 (17%) were positive on microscopy, 39 (30%) on Xpert and 44 (33%) by PS-MTM/PM-PCR. Concordance of PS-MTM/PM-PCR with positive microscopy and Xpert was respectively 96% and 85%. Of 107 microscopy-negative samples, 22 (21%) were positive using PS-MTM/PM-PCR, while 11/91 (12%) Xpert-negative samples were PS-MTM/PM-PCR-positive. PS-MTM/PM-PCR positivity was significantly higher than smear microscopy positivity (P < 0.001), but similar to Xpert (P = 0.33).
  
  
  CONCLUSIONS
  PCR testing of specimens transported in PS-MTM would enhance TB diagnosis in settings where smear microscopy is the baseline diagnostic test, and could provide an alternative in settings where Xpert testing is not available.
authors: Longhorn Vaccines & Diagnostics, San Antonio, Texas, USA.
authors: L T
authors: LT
authors: Daum
authors: Anova Health Institute, Johannesburg, South Africa; Department of Medical Microbiology, University of Pretoria, South Africa; Department of Medical Microbiology, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors: R P H
authors: RP
authors: Peters
authors: Department of Medical Microbiology, University of Pretoria, South Africa.
authors: P B
authors: PB
authors: Fourie
authors: Anova Health Institute, Johannesburg, South Africa.
authors: K
authors: K
authors: Jonkman
authors: Longhorn Vaccines & Diagnostics, San Antonio, Texas, USA.
authors: S A
authors: SA
authors: Worthy
authors: Longhorn Vaccines & Diagnostics, San Antonio, Texas, USA.
authors: J D
authors: JD
authors: Rodriguez
authors: National Institute for Communicable Diseases, National TB Reference Laboratory, Sandringham, South Africa.
authors: N A
authors: NA
authors: Ismail
authors: National Institute for Communicable Diseases, National TB Reference Laboratory, Sandringham, South Africa.
authors: S V
authors: SV
authors: Omar
authors: Longhorn Vaccines & Diagnostics, San Antonio, Texas, USA.
authors: G W
authors: GW
authors: Fischer
mesh_terms: D000328:Adult; D017954:Africa South of the Sahara; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D004269:DNA, Bacterial / Q000032:analysis; D054908:Extensively Drug-Resistant Tuberculosis / Q000175:diagnosis / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification*; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods; D012424:Rural Population; D013048:Specimen Handling / Q000379:methods*; D013183:Sputum / Q000382:microbiology*; D017216:Telemedicine / Q000379:methods*; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis / Q000453:epidemiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000453:epidemiology; D014481:United States; D055815:Young Adult
chemical_list: D004269:DNA, Bacterial