Abdalla et al. (2009)
Brazil
|
Level II:
A comparison against independent, blinded reference standard among consecutive patients
Quality: High risk of bias
Patient selection Index test
Comparator ? Reference std
Flow and timing
Applicability: C1, P2
|
N=34 FFPE skin biopsy specimens from 32 consecutive patients suspected of cutaneous TB or atypical mycobacterial infection
Aged 14–79 years
14/32 male
|
Inclusion
All consecutive patients suspected of cutaneous TB or atypical mycobacterial infection who attended the Dermatologic Clinic of the University of São Paulo Medical School Hospital during the period January 2001 – January 2004
|
PCR using an assay based on oligonucleotide primers specific for the 65-kDa antigen gene of mycobacteria on DNA extracted from FFPE tissue to detect NTM
|
Results of AFB microscopy were obtained from patient records
|
Results of L-J culture were obtained from patient records
Also used a clinical reference standard defined as successful treatment for NTM
|
Bogner et al. (1997)
Germany
Multicentre study of AIDS treatment centres
|
Level III-1:
A comparison against independent, blinded reference standard among non-consecutive patients
Quality: Low risk of bias
Patient selection Index test
Reference std ? Comparator
Flow and timing
Applicability: C1, P1
|
N=540 blood specimens from 107 AIDS patient suspected of having MAC infection, recruited between May 1994 and May 1995, followed up for average of 17.2 ± 11 weeks
Mean age 40.3 ± 9.2 years
Majority male
|
Inclusion
HIV infection, age > 18 years, either symptoms suggestive of MAC disease without other explanation, or MAC positivity in one specimen but no symptoms
Exclusion
Patients with MTB or MAC disease in past, use of anti-TB drugs in previous 8 weeks, life expectancy of < 4 weeks and low Karnofsky index of < 50%
|
PCR (using not-commercially available PCR test kids by Roche) of blood samples to detect Mycobacterium avium
|
Not done
|
Culture of specimens grown in BACTEC 12B vials and on L-J media
|
Choi et al. (2012)
Korea
|
Level III-2:
A comparison with reference standard (not blinded or blinding not known)
Quality: Some risk of bias
Patient selection Index test
Comparator ? Reference std ?
Flow and timing
Applicability: C1, P2
|
N=531 respiratory specimens from 230 patients with suspected mycobacterial infection
482 sputum
49 BAL
|
Inclusion
People with suspected MTB as well as other mycobacteria in July and August 2011
|
Respiratory specimens tested with qPCT-based assay (PNAqPCR TB/NTM kit) targeting the 16S-23S rRNA internal transcribed spacer region to detect NTM
|
AFB microscopy with AUR stain
|
Respiratory specimens cultured in BACTEC MGIT 960 for 6 weeks at 36 ºC
|
Frevel et al. (1999)
Germany
|
Level III-1:
A comparison against independent, blinded reference standard among non-consecutive patients
Quality: High risk of bias
Patient selection Index test
Comparator Reference std
Flow and timing
Applicability: C1, P1
|
N=69 FFPE pulmonary and extrapulmonary samples from patients who were suspected of mycobacterial infections
|
Inclusion
229 FFPE samples from 141 patients who, either for clinical (51%) or histological (49%) reasons, were suspected of MTB or NTM infections initially included in study
|
Pulmonary and extrapulmonary specimens tested with PCR, targeting gene for 65-kDa heat shock protein to detect NTM
|
AFB microscopy using ZN staining was done routinely but results not reported
|
The microbiological results were obtained from patient records
|
Gamboa et al. (1997)
Spain
|
Level III-2:
A comparison with reference standard (not blinded or blinding not known)
Quality: Some risk of bias
Patient selection Index test ?
Comparator Reference std ?
Flow and timing
Applicability: C1, P1
|
N=136 blood specimens from AIDS patients suspected of having disseminated mycobacterial infection Median age 31 years (range 2–55) 80% male
|
Inclusion
Blood specimens and BM aspirates from AIDS patients who were suspected of having disseminated mycobacterial infections and were not receiving anti-TB therapy, and attended April–December 1996
|
Blood and BM specimens tested using the Roche Amplicor MAI PCR-based test to detect Mycobacterium avium and M. intracellulare
|
AFB microscopy using AUR and positive slides confirmed with ZN staining
|
BACTEC 13A cultures were incubated at 37 °C for 8 weeks, and examined for growth with the BACTEC 460 radiometer twice weekly for the first 2 weeks and once weekly thereafter
|
Gazzola et al. (2008)
Italy
|
Level III-2:
A comparison with reference standard (not blinded or blinding not known)
Quality: Some risk of bias
Patient selection Index test ?
Comparator ? Reference std ?
Flow and timing
Applicability: C1, P1
|
N=71 blood samples from 65 AIDS patients suspected of having disseminated mycobacterial infection
N=46 BM specimens from 41 AIDS patients
|
Inclusion
Between March 1999 and April 2004 all episodes of suspected disseminated mycobacterial infections in AIDS patients
|
Blood and BM specimens tested with PCR to detect Mycobacterium avium (no details provided)
|
AFB microscopy using ZN staining for BM specimens only
|
Culture of blood and BM specimens (radiometric BACTEC AFB system)
CRS was clinical diagnosis based on suggestive signs and symptoms plus histopathologic results and response to anti-MAC therapy
|
Kox et al. (1997)
The Netherlands
|
Level III-2:
A comparison with reference standard (not blinded or blinding not known)
Quality: Some risk of bias
Patient selection Index test
Comparator ? Reference std ?
Flow and timing
Applicability: C1, P1
|
N=259 samples from 177 patients:
31 sputum specimens
87 biopsy specimens
37 lymph node biopsies
7 faeces specimens
6 urine specimens
10 blood samples
36 CSF specimens
6 ascitic fluid
15 pleural fluid
3 pericardial fluid
20 BAL
1 gastric lavage
|
Inclusion
Patients for whom difficulties with diagnosis were experienced or could be anticipated (e.g. with granulomatous disease, suspected extrapulmonary TB), immunocompromised patients (i.e. HIV-positive or with AIDS), immigrants and refugees from countries with high incidence of TB, and patients in whom mycobacterial infection other than by MTB was suspected
|
The PCR assays were performed at the Royal Tropical Institute, targeting the 16S DNA sequence to detect NTM, and results were reported to the clinicians within 3 days
|
AFB microscopy done according to standard methods at laboratories of hospitals to which patients were referred
|
Culture done according to standard methods at laboratories of hospitals to which patients were referred
CRS defined as clinical assessment after resolution of discrepancies
|
Mahaisavariya et al. (2005)
Thailand
|
Level III-1:
A comparison against independent, blinded reference standard among non-consecutive patients
Quality: High risk of bias
Patient selection Index test
Comparator ? Reference std
Flow and timing
Applicability: C1, P2
|
N=131 FFPE tissues from 111 patients
Only 120 specimens were cultured at time of processing
Mean age 34.6 years (range 2–73)
58 males
|
Inclusion
Patients with suspected mycobacterial infections (e.g. asymptomatic and slowly progressive skin lesions or cervical lymphadenitis with draining sinus) who attended the Granuloma Clinic, Siriraj Hospital, Mahidol University, Bangkok, between 1994 and 2000
Exclusion
Cases with leprosy and deep fungal infection
|
DNA extracted from FFPE specimens
One-tube nested and multiplex PCR using 16S rRNA sequence as the target to detect NTM
|
Histopathologic sections were reviewed blindly for AFB detection by two independent observers
|
Culture results were retrieved from the patient records
|
Matsumoto et al. (1998)
Japan
|
Level III-2:
A comparison with reference standard (not blinded or blinding not known)
Quality: Low risk of bias
Patient selection Index test
Comparator Reference std ?
Flow and timing
Applicability: C1, P1
|
N=141 bronchial wash specimens from 127 patients
All were HIV–
|
Inclusion
Retrospective analysis of bronchial washing specimens collected from patients suspected of mycobacteriosis, peripheral lung cancer or other miscellaneous pulmonary diseases from August 1995 to March 1997
Exclusion
Patients with a final diagnosis of TB
|
PCR using Amplicor PCR assay to detect Mycobacterium avium
|
AFB microscopy using ZN staining
|
Culture on Ogawa egg medium for up to 8 weeks
|
Ninet et al. (1997)
Switzerland
|
Level III-2:
A comparison with reference standard (not blinded or blinding not known)
Quality: High risk of bias
Patient selection Index test
Comparator Reference std ?
Flow and timing
Applicability: C1, P1
|
N=201 blood samples from HIV-infected patients
|
Inclusion
Retrospective study conducted in the Division of Infectious Disease, Hospital Cantonal Universitaire, Geneva, using blood samples from HIV-infected patients collected over a 2-year period
|
DNA isolated from blood was stored frozen prior to use in PCR with Amplicor MAI (Roche)
Tested for Mycobacterium avium, M. intracellulare and MTB
|
Not done
|
Culture of whole blood in BACTEC 13A medium
|
Phillips et al. (2005)
Ghana
|
Level III-2:
A comparison with reference standard (not blinded or blinding not known)
Quality: Low risk of bias
Patient selection Index test
Comparator Reference std ?
Flow and timing
Applicability: C1, P2
|
N=70 biopsy specimens from 70 patients
|
Inclusion
Punch biopsy specimens were obtained from subjects with a strong clinical suspicion of Mycobacterium ulcerans disease (Buruli ulcer) prior to treatment of the lesion by excision, who presented at St Martin’s Hospital, Agroyesum, Nkawie Hospital and Tepa Hospital between September 2003 and June 2004
|
PCR to detect M. ulcerans targeting IS2404
|
AFB microscopy using ZN staining
|
L-J slopes were incubated at 31 °C, and the cultures were examined weekly until visible growth occurred
CRS was defined as histological diagnosis, or a positive culture for M. Ulcerans
|
Tran et al. (2014)
USA
|
Level III-2:
A comparison with reference standard (not blinded or blinding not known)
Quality: Some risk of bias
Patient selection Index test ?
Comparator Reference std ?
Flow and timing
Applicability: C1, P1
|
N=464 respiratory specimens (sputum and bronchial washes)
|
Inclusion
Specimens received in the Mycobacteriology Laboratory at the Wadsworth Center, New York State, between 1 May 2012 and 1 February 2013 including MTB culture-positive specimens
|
MTBC-MAC multiplex qPCR using 1 forward primer, 5 reverse primers and 2 probes designed to detect the 16S-23S rRNA internal transcribed spacer region of all MAC strains
|
AFB microscopy using ZN staining
|
Specimens were cultured using the BACTEC MGIT 960 system
|
