Fluorescein diacetate and rapid molecular testing for the early identification of rifampicin resistance in Mali

2020 ◽  
Vol 24 (8) ◽  
pp. 763-769
Author(s):  
B. Diarra ◽  
T. Decroo ◽  
A. Somboro ◽  
G. Coulibaly ◽  
M. Tolofoudie ◽  
...  
Keyword(s):  
Predictive Value ◽  
Early Identification ◽  
Fluorescein Diacetate ◽  
Rifampicin Resistance ◽  
Smear Microscopy ◽  
Molecular Testing ◽  
Full Spectrum ◽  
Pulmonary Tb ◽  
Resistant Tuberculosis ◽  
Baseline Screening

BACKGROUND: Non-conversion on auramine smear microscopy indicates a lack of treatment response, possibly associated with initial rifampicin-resistant tuberculosis (RR-TB). However, dead bacteria still stain positive and may be detected. Fluorescein diacetate smear microscopy (FDA) shows live mycobacteria only. Therefore, we studied the potential of 2-month (2M) FDA for the identification of initial RR-TB.METHODS: Between 2015 and 2018, we enrolled new smear-positive pulmonary TB patients from five local centres in Bamako, Mali. After baseline screening, sputum samples were collected at 1M, 2M, 5M and 18M. We used rpoB sequencing to identify initial RR-TB.RESULTS: Of 1359 patients enrolled, 1019 (75%) had rpoB sequencing results. Twenty-six (2.6%, 95%CI: 1.7–3.7) had mutations conferring rifampicin resistance. Most frequent rpoB mutations were located at the codons Asp435Val (42.4%) and Ser450Leu (34.7%). Among patients with initial RR-TB, 72.2% were FDA-negative at 2M (P = 0.2). The positive and negative predictive value of 5M FDA for culture-based failure was respectively 20.0% and 94.7%.CONCLUSION: FDA did not identify the majority of patients with initial RR-TB or culture-based failure. As the full spectrum of mutations identified on sequencing was identified using Xpert, our data support its rapid universal implementation in Mali.

scholarly journals Comparison of Auramine Phenol and ZN Staining in Diagnosis of Pulmonary Tuberculosis with GeneXpert MTB/RIF as Gold Standard

2020 ◽  
Vol 9 (3) ◽  
pp. 190-194
Author(s):  
Naureen Saeed ◽  
Fatima-tuz-zuhra ◽  
Nadeem Ikram ◽  
Farhana Shaukat ◽  
Fareeha Sardar
Keyword(s):  
Pulmonary Tuberculosis ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Gold Standard ◽  
Sputum Sample ◽  
False Negative ◽  
Smear Microscopy ◽  
Predictive Values ◽  
Pulmonary Tb ◽  
Sensitivity Specificity

Background: Pakistan faces an immense burden of pulmonary tuberculosis (TB) due to large number of cases and limited resources. Despite the recent advancement in the diagnostic techniques for pulmonary TB, smear microscopy is still a useful technique for the diagnosis of this disease. This study was conducted in order to compare the diagnostic value of Auramine stain with the conventional Ziehl-Neelsen (ZN) stain on the sputum smear for the diagnosis of pulmonary TB, keeping GeneXpert MTB/RIF as the gold standard. Method: This cross-sectional study was conducted on 356 suspected patients of pulmonary TB referred to the Pathology laboratory from TB ward and OPD of District Head Quarter (DHQ) teaching hospital Rawalpindi, Pakistan. Sputum specimen were collected and two smears were prepared from each sputum sample on which Auramine phenol and Ziehl-Neelsen staining were carried out as per WHO recommendations. All these samples were further tested using Gene Xpert MTB/RIF technique. The sensitivity, specificity, Positive predictive value (PPV) and Negative predictive values (NPV) of ZN and Auramine stain were calculated and compared with GeneXpert MTB/RIF technique. Results: Out of the total 356 samples, 64(18%) were positive and 291(82%) were negative by GeneXpert which was taken as the gold standard. On comparison with GeneXpert, percentage of true positive was greater in case of Auramine than ZN stained samples (16.29% versus 12.92%), while the percentage of false positive was same for both staining techniques (0.28%). There were lesser false negative cases observed in samples stained by Auramine as compared to the ones stained by ZN (1.68% versus 5.05%). The sensitivity, specificity, positive predictive value and negative predictive values were 97.87%, 94.17%, 71.88 and 99.66%, respectively for the ZN staining and 98.31%, 97.98%, 90.63% and 99.66% respectively, for the Auramine phenol staining. Conclusion: Smear microscopy using Auramine phenol stain is a useful technique for the diagnosis of pulmonary TB. The Auramine phenol staining with fluorescent microscopy is found to be superior to ZN staining because of higher sensitivity and specificity. Keywords: Auramine phenol, Fluorescence microscopy, GeneXpert, Mycobacterium tuberculosis, Ziehl-Neelsen

scholarly journals Performance of the WHO 2011 TB Symptom Screening Algorithm for Pulmonary TB Diagnosis among HIV-Infected Patients in Gondar University Referral Hospital, Ethiopia

2016 ◽  
Vol 2016 ◽  
pp. 1-5 ◽  
Author(s):  
Martha Alemayehu Menberu
Keyword(s):  
Risk Factors ◽  
Predictive Value ◽  
Clinical Symptoms ◽  
Diagnostic Delay ◽  
Smear Microscopy ◽  
Cross Sectional ◽  
Pulmonary Tb ◽  
Symptom Screening ◽  
Screening Algorithm ◽  
Night Sweats

The new WHO 2011 guidelines on TB screening among HIV-infected individuals recommend screening using four TB symptoms (current cough, fever, weight loss, and night sweats). This study aimed to assess the performance of WHO 2011 TB symptom screening algorithm for diagnosing pulmonary TB in HIV patients and identify possible risk factors for TB. Institutional based cross-sectional study was conducted from February 2012 to November 2012. A total of 250 HIV-infected patients aged ≥18 years visiting the University of Gondar Hospital, ART clinic, were enrolled. Information about WHO TB clinical symptoms and other known risk factors for TB was collected using structured questionnaire. Spot-morning-spot sputum samples were collected and direct AFB microscopy, sputum culture, and RD9 molecular typing were performed. Statistical data analysis was performed using SPSS Version 20.0 software. Of 250 study participants, fever was reported in 169 (67.6%), whereas cough and night sweats were reported in 167 (66.8%) and 152 (60.8%), respectively. A total of 11 (4.4%) TB cases were identified. Of these, 82% (9/11) TB patients reported cough, so that the negative predictive value was 98%. In addition, 66% (158/239) TB negative patients reported cough, so that positive predictive value of cough was 5%. According to the new WHOTB symptom screening algorithm, out of 250 HIV-infected persons, 83% (5/6) have been investigated by TB symptom screening and AFB smear microscopy. Therefore, the 2011 WHO TB symptom screening tool for the diagnosis of pulmonary TB is likely to reduce the diagnostic delay and lower TB morbidity and mortality rate particularly in HIV prevalent settings.

scholarly journals Xpert MTB/RIF performance to diagnose tuberculosis and rifampicin resistance in a reference centre in southern Brazil

2019 ◽  
Vol 5 (3) ◽  
pp. 00043-2019
Author(s):  
Cinara Silva Feliciano ◽  
Lucas José Bazzo Menon ◽  
Livia Maria Pala Anselmo ◽  
Anzaan Dippenaar ◽  
Robin Mark Warren ◽  
...  
Keyword(s):  
Predictive Value ◽  
Public Health Problem ◽  
Illumina Miseq ◽  
Healthcare Facility ◽  
Cross Sectional Study ◽  
Rifampicin Resistance ◽  
Diagnostic Strategy ◽  
Cross Sectional ◽  
Pulmonary Tb ◽  
Resistant Disease

Effective treatment of tuberculosis (TB) remains a serious public health problem in many countries, including Brazil, especially when considering drug-resistant disease. Xpert MTB/RIF has been implemented in many countries to reduce the time to TB diagnosis and to rapidly detect rifampicin resistance. The study aimed to describe and evaluate Xpert MTB/RIF performance in diagnosing pulmonary TB and rifampicin resistance in a tertiary healthcare facility in Brazil.A cross-sectional study was performed, which included all isolates of confirmed pulmonary TB patients from 2015 to 2018. Both Xpert MTB/RIF and GenoType MTBDRplus assays were performed to detect rifampicin and isoniazid resistance. In addition, isolates with detected resistance to rifampicin and/or isoniazid were analysed by phenotypic testing using MGIT-960 SIRE kit and whole-genome sequencing (WGS) using Illumina MiSeq Sequencing System.2148 respiratory specimens tested with Xpert MTB/RIF were included: n=1556 sputum, n=348 bronchoalveolar lavage and n=244 gastric washing. The overall Xpert MTB/RIF sensitivity in sputum was 94% and the overall specificity was 98%. The negative predictive value in sputum of all the patients was 99% with a positive predictive value of 89%. The concordance between Xpert MTB/RIF and phenotypic susceptibility test was 94.1%, while its concordance with WGS was 78.9%.Xpert MTB/RIF is a rapid and accurate diagnostic strategy for pulmonary TB, which can contribute to improvement in TB control. However, detection of rifampicin resistance might be associated with false-positive results.

scholarly journals Xpert Mycobacterium tuberculosis/Rifampicin–Detected Rifampicin Resistance is a Suboptimal Surrogate for Multidrug-resistant Tuberculosis in Eastern Democratic Republic of the Congo: Diagnostic and Clinical Implications

2020 ◽  
Author(s):  
Bertin C Bisimwa ◽  
Jean B Nachega ◽  
Robin M Warren ◽  
Grant Theron ◽  
John Z Metcalfe ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Predictive Value ◽  
Democratic Republic ◽  
Multidrug Resistant ◽  
Resistance Testing ◽  
Smear Microscopy ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Mdr Tb ◽  
Republic Of The Congo

Abstract Background Rifampicin (RIF) resistance is highly correlated with isoniazid (INH) resistance and used as proxy for multidrug-resistant tuberculosis (MDR-TB). Using MTBDRplus as a comparator, we evaluated the predictive value of Xpert MTB/RIF (Xpert)–detected RIF resistance for MDR-TB in eastern Democratic Republic of the Congo (DRC). Methods We conducted a cross-sectional study involving data from new or retreatment pulmonary adult TB cases evaluated between July 2013 and December 2016. Separate, paired sputa for smear microscopy and MTBDRplus were collected. Xpert testing was performed subject to the availability of Xpert cartridges on sample remnants after microscopy. Results Among 353 patients, 193 (54.7%) were previously treated and 224 (63.5%) were MTBDRplus TB positive. Of the 224, 43 (19.2%) were RIF monoresistant, 11 (4.9%) were INH monoresistant, 53 (23.7%) had MDR-TB, and 117 (52.2%) were RIF and INH susceptible. Overall, among the 96 samples detected by MTBDRplus as RIF resistant, 53 (55.2%) had MDR-TB. Xpert testing was performed in 179 (50.7%) specimens; among these, 163 (91.1%) were TB positive and 73 (44.8%) RIF resistant. Only 45/73 (61.6%) Xpert-identified RIF-resistant isolates had concomitant MTBDRplus-detected INH resistance. Xpert had a sensitivity of 100.0% (95% CI, 92.1–100.0) for detecting RIF resistance but a positive-predictive value of only 61.6% (95% CI, 49.5–72.8) for MDR-TB. The most frequent mutations associated with RIF and INH resistance were S531L and S315T1, respectively. Conclusions In this high-risk MDR-TB study population, Xpert had low positive-predictive value for the presence of MDR-TB. Comprehensive resistance testing for both INH and RIF should be performed in this setting.

scholarly journals Is Rapid Molecular Testing Enough In Screening Drug-Resistant Tuberculosis In Community?

2021 ◽  
Author(s):  
Ashok Dhaker ◽  
Ashish Bahal ◽  
Vishal Mangal ◽  
Arun K Yadav ◽  
Anuj Singhal ◽  
...  
Keyword(s):  
Sputum Sample ◽  
Nucleic Acid Amplification ◽  
Smear Microscopy ◽  
Molecular Testing ◽  
Drug Resistant ◽  
Second Line ◽  
First Line ◽  
Sensitivity Testing ◽  
Drug Resistant Tuberculosis ◽  
Resistant Tuberculosis

Background: The study aimed to compare the sensitivity and specificity of cartridge-based nucleic acid amplification test (CBNAAT) for diagnosis of Drug-Resistant Tuberculosis (DRTB) with culture sensitivity assays. Methods: Patients with cough symptoms for more than two weeks with any one symptom such as night sweats, fever, and unintentional weight loss were enrolled. Cases where Mycobacterium Tuberculosis was detected on sputum CBNAAT, were included in the study. Demographic variables, clinical features, and chest radiographs were collected. Each sputum sample was divided into three aliquots: smear microscopy, culture, and genotypic drug sensitivity testing (DST). Results of all three diagnostic modalities were compared with CBNAAT. Results: Out of 236 patients with sputum positive CBNAAT, 49.4 % (117/236) were rifampicin-resistant while 50. 6 % (119/236) were Rifampicin sensitive. The genotypic DST assays carried out on all enrolled patients showed that 76. 3 % (181/236) patients were resistant to one or more first-line or second-line antitubercular (ATT) drugs, while 23.7 % (55/236) patients were sensitive to all ATT drugs. On concordant analysis of CB NAAT with DST assays, we found that among 119 CB NAAT rifampicin sensitive patients, 66 patients were resistant to first-line or second-line antitubercular drugs. Conclusion: This study found that the screening of DRTB with CBNAAT at the community level is suboptimal compared to the gold standard. Although CBNAAT's sensitivity in detecting DRTB is significantly higher, the specificity is lower in that population who have received ATT earlier.

scholarly journals Diagnostic Performance of Xpert MTB/RIF in Bronchoalveolar Lavage of Sputum-Scarce Recurrent Pulmonary Tuberculosis Cases

2020 ◽  
Vol 10 (02) ◽  
pp. 74-78
Author(s):  
Pratibha Sharma ◽  
Abhishek Kumar ◽  
Mamatha S. ◽  
Ranganath T. Ganga
Keyword(s):  
Bronchoalveolar Lavage ◽  
Predictive Value ◽  
Diagnostic Performance ◽  
Nontuberculous Mycobacteria ◽  
Cross Reactivity ◽  
Rifampicin Resistance ◽  
Nontuberculous Mycobacterium ◽  
Sputum Smear ◽  
Smear Microscopy ◽  
Composite Reference Standard

Abstract Introduction Xpert MTB/RIF has greater sensitivity and specificity than smear microscopy. Bronchoalveolar lavage (BAL) is safe and valuable tool in sputum-scarce and sputum-negative tuberculosis (TB) patients. Our study evaluated the performance of Xpert in BAL specimen of sputum-scarce recurrent TB cases exclusively. Materials and Methods Sputum-scarce recurrent TB patients who underwent BAL between July 2018 and July 2019 were included. The diagnostic performance of Xpert and acid-fast bacilli (AFB) smear examination in BAL specimen was compared with liquid culture Mycobacterium TB (MTB) and composite reference standard. Results A total of 126 patients were included in the study. MTB culture was positive in 70 cases and nontuberculous mycobacteria were seen in five cases. Xpert was positive was in 63 patients. Sensitivity of Xpert and AFB smear was 84.29% (95% confidence interval [CI]: 73.62–91.89) and 18.57% (95% CI: 10.28–29.66), respectively, with p < 0.001 proving the superiority of Xpert. Xpert had a specificity of 97.96 (89.15–99.95), positive predictive value of 93.65% (95% CI 85.19–97.42), and negative predictive value of 80.36% (95% CI: 70.26–87.63). Smear had a specificity of 91.84% (95% CI: 80.21–97.58) against 97.96 (89.15–99.95) of Xpert, and smear was positive in nontuberculous mycobacterium cases as well. Xpert showed no cross-reactivity between mycobacterial species. Rifampicin resistance was seen in 8 (12.69%) cases, and 21 patients had other diagnoses. Conclusion Xpert has greater sensitivity in comparison to AFB smear in BAL specimen. Sputum-scarce recurrent TB cases have a similar chance of rifampicin resistance as sputum smear-positive cases should undergo BAL for Xpert analysis routinely.

scholarly journals Diagnostic Accuracy of Ziehl-Neelsen Smear Microscopy in Comparison with GeneXpert in Pulmonary Tuberculosis: A Multi-Center Study in Kandahar Province, Afghanistan

2021 ◽  
pp. 1-7
Author(s):  
Mujeeb Ahmad ◽  
Muhammad Haroon Stanikzai ◽  
Najeeb Rahimy ◽  
Abdul Wahed Wasiq ◽  
Hadia Sayam
Keyword(s):  
Pulmonary Tuberculosis ◽  
Positive Predictive Value ◽  
Diagnostic Accuracy ◽  
Negative Predictive Value ◽  
Disease Transmission ◽  
Predictive Value ◽  
Smear Microscopy ◽  
Cross Sectional ◽  
Pulmonary Tb ◽  
Kappa Value

Background: Tuberculosis (TB) is a major global health problem. The early and accurate diagnosis is crucial for disease management and to control disease transmission and the emergence of drug resistance TB. Objectives: This study was carried out to determine the diagnostic accuracy of Ziehl Neelsen (ZN) smear microscopy in comparison with GeneXpert MTB/RIF in pulmonary tuberculosis in Kandahar province, Afghanistan. Methods: This was a facility-based cross-sectional study. We scrutinized TB registers of three health facilities to include patients who had their sputum tested by both ZN smear microscopy and GeneXpert MTB/RIF. We extracted 734 patients’ data registered during January 2019 - June 2020 in a structured form. Kappa value was analyzed using SPSS version 19 software at 95% Confidence Interval (CI). We calculated sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of ZN smear microscopy against GeneXpert MTB/RIF. Results: In comparison with GeneXpert as a reference test, ZN smear microscopy has 67.7% (95% CI:63.44%-70.74%) sensitivity and 100% (95% CI:98.74%-100.00%) specificity. The positive predictive value (PPV) and negative predictive value (NPV) were 100% and 99.89% (95% CI:99.88%-99.90%), respectively. The agreement between ZN smear microscopy and GeneXpert MTB/RIF results was moderate (70.4%) and the Kappa value was 0.45 (95% CI:0.38-0.59). Conclusion: This study has found high specificity but moderate sensitivity for the diagnosis of pulmonary TB using sputum ZN smear microscopy test. Hence, GeneXpert MTB/RIF test is more accurate and reliable for the diagnosis of pulmonary TB.

scholarly journals A Retrospective Cross-Sectional Study of the Utility of Cartridge-Based Nucleic Acid Amplification Test in Diagnosis of Pulmonary and Extrapulmonary Tuberculosis in People Living with HIV in Second Highest HIV Prevalent State in India

2021 ◽  
Author(s):  
Tade Bagbi ◽  
Ningthoukhongjam Reema ◽  
S. Bhagyabati Devi ◽  
Thangjam Gautam Singh ◽  
Mohammad Jaleel ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Cross Sectional Study ◽  
Nucleic Acid Amplification Test ◽  
Nucleic Acid Amplification ◽  
Rifampicin Resistance ◽  
Sputum Smear ◽  
Smear Microscopy ◽  
Sectional Study ◽  
Cross Sectional ◽  
Smear Negative

Abstract Introduction Tuberculosis (TB) in people living with human immunodeficiency virus (PLHIV) is difficult to diagnose due to fewer organisms in sputum and extrapulmonary samples. Sputum culture takes 4 to 8 weeks for growth of the mycobacteria. Delayed treatment for TB in PLHIV leads to increased mortality. This study evaluated cartridge-based nucleic acid amplification test (CBNAAT) as a diagnostic tool for diagnosis of pulmonary TB (PTB) and extrapulmonary TB (EPTB) in PLHIV in the second most HIV prevalent state in India and for comparing its efficacy between Ziehl–Neelsen (ZN) staining sputum smear–positive and sputum smear–negative TB. Methods This cross-sectional study was conducted in RIMS, Imphal, with 167 PLHIV patients, age 15 years or older, having signs and symptoms of TB. Appropriate samples for sputum microscopy and CBNAAT were sent. Conclusion The overall sensitivity of sputum smear for acid-fast bacillus (AFB) was found to be 30.71% and that of CBNAAT was 38.57%. Sensitivity of CBNAAT for sputum smear–positive and sputum smear–negative TB was 100 and 11.3%, respectively. Sensitivity of ZN smear for AFB of EPTB sample was 48.1% and that of CBNAAT was 59.25%. In both PTB and EPTB, CBNAAT showed an increase in diagnosis of microbiologically confirmed PTB cases by 7.8 and 11.1%, respectively, over and above the cases diagnosed by ZN smear microscopy. Rifampicin resistance was detected in five patients. We conclude that CBNAAT is a rapid test with better sensitivity in diagnosis of PTB and EPTB in PLHIV, compared with ZN smear microscopy. It detects rifampicin resistance for multidrug-resistant TB and helps in early treatment intervention.

scholarly journals Use of fluorescein diacetate (FDA) staining to detect viable Mycobacterium tuberculosis

2012 ◽  
Vol 11 (4) ◽  
pp. 322-330 ◽  
Author(s):  
Shamima Islam ◽  
Farjana Rahman ◽  
Saurab Kisore Munshi ◽  
Jewel Ahmed ◽  
S M Mostafa Kamal ◽  
...  
Keyword(s):  
Mycobacterium Tuberculosis ◽  
Treatment Failure ◽  
Medical Science ◽  
Multidrug Resistant ◽  
Fluorescein Diacetate ◽  
Drug Resistant ◽  
Drug Resistant Tuberculosis ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Auramine O

Objective: Drug resistant tuberculosis has long been a common problem prevailing in developing countries including Bangladesh. Present study focused on the rapid identification of live Mycobacterium tuberculosis among treatment failure cases.Materials and Methods: Sputum samples from a total of 100 category-I and category-II treatment failure cases, assumed as multidrug resistant tuberculosis, were studied through fluorescein diacetate (FDA) staining under light emitting diode (LED) fluorescence microscope. Considering culture method as gold standard, we also compared the results of FDA staining with that of auramine O staining.Results: A total of 85% acid-fast bacilli were detected by FDA staining, 82% by auramine O staining and a total of 85% isolates were detected in Lowenstein-Jensen (LJ) culture. The sensitivity of FDA staining (96.47%) was estimated to be slightly higher than that of auramine O staining (91.76%). Moreover,76.47% cases were detected as multidrug resistant tuberculosis (MDR-TB). Conclusion: Taken together, FDA staining method has been proposed to be appropriate for the rapid diagnosis of drug resistant tuberculosis. DOI: http://dx.doi.org/10.3329/bjms.v11i4.12605 Bangladesh Journal of Medical Science Vol. 11 No. 04 Oct’12

scholarly journals Development and Evaluation of a Novel Fast Broad-Range ITS/LSU DNA PCR and Sequencing Assay (FBR-PCR/S) for Rapid Diagnosis of Invasive Fungal Diseases: Multi-Year Experience in a Large Canadian Healthcare Zone and a Literature Review

2021 ◽  
Author(s):  
B Chow ◽  
M Groeschel ◽  
J Carson ◽  
Thomas Griener ◽  
Deirdre Church
Keyword(s):  
Predictive Value ◽  
Patient Characteristics ◽  
Invasive Fungal Disease ◽  
Molecular Testing ◽  
Fungal Culture ◽  
Diagnostic Efficiency ◽  
Molecular Assay ◽  
Risk Patients ◽  
Sensitivity Specificity ◽  
Canadian Healthcare

Abstract BackgroundThis study evaluated the performance of a novel fast broad range PCR and sequencing (FBR-PCR/S) assay for the improved diagnosis of invasive fungal disease (IFD) in high-risk patients in a large Canadian healthcare region.MethodsA total of 114 clinical specimens (CS) including bronchoalveolar lavages (BALs) were prospectively tested from 107 patients over a 2-year period. Contrived BALs (n=33) inoculated with known fungi pathogens were also tested to increase diversity. Patient characteristics, fungal stain and culture results were collected from the laboratory information system. Dual-priming oligonucleotide (DPO) primers targeted to the ITS (~350 bp) and LSU (~550 bp) gene regions were used to perform FBR-PCR/S assays on extracted BALs/CS. The performance of the molecular test was evaluated against results of fungal stains and culture, and where available, histopathology, and clinical review for the presence of IFD.ResultsThe 107 patients were predominantly male (67, 62.6%%) with a mean age of 59 yrs. (range = 0 to 85 yrs.): 74 (69.2%) patients had at least one underlying comorbidity: 19 (34.5%) had confirmed and 12 (21.8%) had probable IFD. Culture recovered 66 fungal isolates from 55 BALs/CS with Candida spp. and Aspergillus spp. being most common. For BALs, the molecular assay vs. fungal culture had sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), and efficiency of 88.5% vs.100%, 100% vs. 61.1%, 100% vs. 88.5%, 61.1% vs. 100%, and 90.2% for both. For other CS, the molecular assay had similar performance to fungal culture with sensitivity, specificity, PPV, NPV and efficiency of 66.7%, 87.0%, 66.7%, 87.0% and 81.3% for both methods. Both methods also performed similarly, regardless of whether CS stain/microscopy showed yeast/fungal elements. FBR-PCR/S assays results were reported in ~8h compared to fungal cultures that took between 4 to 6 weeks.ConclusionsRapid molecular testing compared to culture has equivalent diagnostic efficiency but improves clinical utility by reporting a rapid species-level identification the same dayshift (~8h).

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