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Multicenter Evaluation of the BioFire FilmArray Gastrointestinal Panel for Etiologic Diagnosis of Infectious Gastroenteritis
Open accessAbstract
The appropriate treatment and control of infectious gastroenteritis depend on the ability to rapidly detect the wide range of etiologic agents associated with the disease. Clinical laboratories currently utilize an array of different methodologies to test for bacterial, parasitic, and viral causes of gastroenteritis, a strategy that suffers from poor sensitivity, potentially long turnaround times, and complicated ordering practices and workflows. Additionally, there are limited or no testing methods routinely available for most diarrheagenic Escherichia coli strains, astroviruses, and sapoviruses. This study assessed the performance of the FilmArray Gastrointestinal (GI) Panel for the simultaneous detection of 22 different enteric pathogens directly from stool specimens: Campylobacter spp., Clostridium difficile (toxin A/B), Plesiomonas shigelloides , Salmonella spp., Vibrio spp., Vibrio cholerae , Yersinia enterocolitica , enteroaggregative E. coli , enteropathogenic E. coli , enterotoxigenic E. coli , Shiga-like toxin-producing E. coli ( stx 1 and stx 2 ) (including specific detection of E. coli O157), Shigella spp./enteroinvasive E. coli , Cryptosporidium spp., Cyclospora cayetanensis , Entamoeba histolytica , Giardia lamblia , adenovirus F 40/41, astrovirus, norovirus GI/GII, rotavirus A, and sapovirus. Prospectively collected stool specimens ( n = 1,556) were evaluated using the BioFire FilmArray GI Panel and tested with conventional stool culture and molecular methods for comparison. The FilmArray GI Panel sensitivity was 100% for 12/22 targets and ≥94.5% for an additional 7/22 targets. For the remaining three targets, sensitivity could not be calculated due to the low prevalences in this study. The FilmArray GI Panel specificity was ≥97.1% for all panel targets. The FilmArray GI Panel provides a comprehensive, rapid, and streamlined alternative to conventional methods for the etiologic diagnosis of infectious gastroenteritis in the laboratory setting. The potential advantages include improved performance parameters, a more extensive menu of pathogens, and a turnaround time of as short as 1 h.
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“The low percentage of failures (6/1,577 [0.38%]) is consistent with other published data on different FilmArray panels and indicates there was not a significant amount of inhibition of PCR in the samples (15).”
From Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens (2016) · cites this paper as [15]
In the citing paper
“The low percentage of failures (6/1,577 [0.38%]) is consistent with other published data on different FilmArray panels and indicates there was not a significant amount of inhibition of PCR in the samples (15).”
From Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens (2016) · cites this paper as [15]
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Doxycycline Malaria Prophylaxis Impact on Risk of Travelers’ Diarrhea among International Travelers
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“With advances in etiologic determination using molecular-based diagnostics, there is increased capability to identify the causative agent of TD.(14,15)”
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“Previous studies have showed that the mPCR tests demonstrate good specificity compared to standard molecular methods (27, 28).”
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“The BioFire® FilmArray gastrointestinal panel (FGP) is a multiplex polymerase chain reaction (PCR) test that can simultaneously test for 22 different viruses, bacteria, and parasites with excellent sensitivity and specificity with a one-hour turnaround time [6].”
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“4% of samples.(12,13) Interestingly, data from LUMC show prevalence to be significantly greater during summer months, a trend that has been noted by others for diarrheagenic E.”
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“Buss [43] 1556 specimens from 4 medical centers 2013, USA 832 of 1556 (54%) positive specimens Most commonly detected: EPEC, C.”
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“A positive result may reflect colonization rather than infection and may not warrant treatment.(23) For this reason, some facilities suppress the C.”
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“…available, permitting the simultaneous detection of the most common diarrheagenic pathogens with high throughput and short detection times, such as BioFire FilmArray gastrointestinal panel and Luminex xTAG Gastrointestinal Pathogen Panel (Khare et al., 2014; Liu et al., 2014; Buss et al., 2015).”
BackgroundClinical decision support for gastrointestinal panel testing
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Why pathogen genomics is crucial in Africa’s public health
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“A number of FDA- cleared multiplexed assays are available for use in clinical laboratories and target a wide range of bacterial, viral, and parasitic pathogens, including: BioFire FilmArray Gastrointestinal Panel (BioFire, Salt Lake City, UT, USA) [5], the xTAG Gastrointestinal Pathogen Panel (Luminex Corporation, Aus…”
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“These panels enable physicians to screen for a large number of gastrointestinal pathogens simultaneously and have high sensitivity and specificity for several pathogens, including cryptosporidiosis (8,9).”
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“The high confirmation rate by autofluorescence microscopy demonstrates the reliability of FilmArray GI Cyclospora-positive results with a large number of real-world clinical specimens [the number of FilmArray GI-positive specimens in this outbreak (99 specimens) is more than 5 times higher than the number of positive…”
BackgroundMolecular Diagnostic Methods for Detection and Characterization of Human Noroviruses
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“Noroviruses were among the most frequently detected pathogens in mixed infections [81, 82, 87].”
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“Recent advances in detection of enteric pathogens using multi-pathogen panels, which include targets for HAdV-F, have allowed more accurate detection of HAdV-F in stool [11,12].”
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“Although commercial testing may show higher efficiencies in detecting enteric pathogens [6,7], the effectiveness of molecular techniques in diagnosing helminthic infections is an ongoing discussion.”
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“A multicenter trial using the BioFire panel identified 1180 potential pathogens in 1556 specimens tested, demonstrating 100% sensitivity for 12/22 targets and 94.5% for an additional 7/22 targets [81].”
MethodInfluentialKang, H. M., Yoo, I. H., & Jeong, D. C. (2024) · Annals of Clinical Microbiology and Antimicrobials · doi:10.1186/s12941-023-00662-3 · Cited by 9
“…panels for detection and identification of causative gastrointestinal (GI) pathogens from the stools of patients with acute diarrhea have shown to be highly sensitive [15–18], and major advantages include the rapid turnaround time and ability to detect the presence of a variety pathogens [15].”
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“Whereas sensitivity values of 1 have been achieved with the EasyScreen enteric parasite detection kit (Genetic Signatures, Sydney, Australia) (24) and the FilmArray gastrointestinal panel (BioFire Diagnostics, Salt Lake City, UT, USA) (25), lower values of 0.96 to 0.97 have been reported with the BD MAX enteric parasi…”
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BackgroundSelf-citationNoninfectious causes of fever in hematologic malignancies. Are antibiotics still indicated?
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“In particular, the microfluidic, multiplex PCR platform was developed for the detection of multiple gastrointestinal pathogens [47,48].”
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“However, the CCNA procedure is complicated, time-consuming, and limited by cell types and equipment (Buss et al. 2015).”
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“Comparison studies of current syndromic panels have demonstrated equivalent or even superior performance to reference assays [45,48,49].”
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Detection of Acute Gastroenteritis Agents By Molecular Methods
Göktas, S., Gökmen, A. A., & Şamlıoglu, P. (2018) · doi:10.5799/jcei.413060 · Cited by 7
“Farklı ticari multiplex PZR kitlerinin kullanıldığı üç farklı çalışmada koenfeksiyon oranı %14,2, %31,5, %33,5 olarak bulunmuştur [4,13-15].”
Diagnostics in a Forward Deployed Setting.
Swierczewski, B., & Simons, M. (2017) · Military Medicine · doi:10.7205/milmed-d-17-00069 · Cited by 7
Molecular Contamination and Amplification Product Inactivation
Sefers, S. E., & Schmitz, J. E. (2018) · Springer eBooks · doi:10.1007/978-3-319-33900-9_24 · Cited by 6
Yoo, I., Jo, S., Kwon, J., Han, J., Lee, H. K., & Park, Y.-J. (2025) · Annals of Laboratory Medicine · doi:10.3343/alm.2025.0047 · Cited by 6
“However, 20–36% false positive (FP) results were reported for norovirus with the FilmArray GI Panel [6–8].”
Szymczak, W. A., Engsbro, A. L., Lisby, J. G., González‐López, J. J., Granato, P. A., Ledeboer, N. A., Wolk, D. M., Young, S., Rhoads, D. D., Caspar, Y., et al. (2025) · Journal of Clinical Microbiology · doi:10.1128/jcm.01983-24 · Cited by 5
“For this investigation, 1,939 specimens prospectively collected from nine clinical sites in the United States and four clinical sites in Europe were evaluated (Table 1).”
InfluentialKutar, M., Desai, D. C., Abraham, P., Gupta, T., & Dhoble, P. (2025) · Indian Journal of Gastroenterology · doi:10.1007/s12664-025-01773-9 · Cited by 6
“Stool multiplex molecular polymerase chain reaction (PCR) assay allows for simultaneous detection of nucleic acids from 22 bacteria, viruses and parasites from stool samples sent in Cary Blair transport medium [3].”
A Multimodal Intervention to Reduce C. difficile Infections and Stool Testing
Cotter, J. M., Stokes, C. L., Tong, S., Birkholz, M. C., Child, J., Cost, C. R., Coughlin, R. L., Cox, S., Dolan, S. A., Dorris, K. M. O., et al. (2024) · PEDIATRICS · doi:10.1542/peds.2023-061981 · Cited by 4
Pavia, A. T., Cohen, D. M., Leber, A. L., Daly, J. A., Jackson, J. T., Selvarangan, R., Kanwar, N., Bender, J. M., Bard, J. D., Festekjian, A., et al. (2023) · Clinical Infectious Diseases · doi:10.1093/cid/ciad710 · Cited by 12
Self-citationRichins, T., Houghton, K., Barratt, J., Sapp, S., Peterson, A. C., & Qvarnstrom, Y. (2023) · Microbiology spectrum · doi:10.1128/spectrum.01388-23 · Cited by 6
“In the years after the BioFire FilmArray GI Panel (BioFire assay) became available for clinical use, the number of laboratory-confirmed cyclosporiasis cases has increased, owing at least in part to the use of this new diagnostic test; this phenomenon was especially pronounced during the 2018 cyclosporiasis peak period…”
ResultPeterson, A., Richins, T., Houghton, K., Mishina, M., Sharma, S. D., Sambhara, S., Jacobson, D. K., Qvarnstrom, Y., & Cama, V. (2023) · Diagnostic microbiology and infectious disease · doi:10.1016/j.diagmicrobio.2023.116030 · Cited by 6
Bardales, P. F. G., Schiaffino, F., Huynh, S., Olórtegui, M. P., Yori, P. P., Vasquez, T. N. P., Villanueva, K. M., Huansi, G. E. C., López, W. V. S., Cooper, K. K., et al. (2022) · PLoS Neglected Tropical Diseases · doi:10.1371/journal.pntd.0010869 · Cited by 6
“This is partly a result of a larger proportion of cases diagnosed using nucleic acid-based techniques or ELISA, which is higher in low-income settings in comparison to high-income settings and in part secondary to limited capacity and funds to sequence genomes that are isolated in LMIC settings [4,5].”
Poulain, C., Héctor Galeno, A., Loayza, S., Vergara, N., Valdivieso, F. R., Coria, P., Sotomayor, V., Simian, M. E., Acevedo, J., & Farfán, M. J. (2021) · Revista chilena de infectología · doi:10.4067/s0716-10182021000100054 · Cited by 7
Yang, Y., Rajendran, V., Jayaraman, V., Wang, T., Bei, K., Krishna, K., Rajasekaran, K., Rajasekaran, J. J., & Krishnamurthy, H. K. (2019) · Gut Pathogens · doi:10.1186/s13099-019-0329-2 · Cited by 11
Faron, M., Ledeboer, N., Connolly, J., Granato, P., Alkins, B. R., Bard, J. D., Daly, J., Young, S., & Buchan, B. (2016) · Journal of Clinical Microbiology · doi:10.1128/jcm.01939-16 · Cited by 6
“than routine culture and EIA methods (7, 12, 15).”
MethodEvans, T. O., Fominyam, T., Matthews, S., Bailey, M., & Hutley, E. (2016) · Journal of the Royal Army Medical Corps · doi:10.1136/jramc-2016-000662 · Cited by 6
Çetin, S., Telli, E., Şahin, A. M., Uğur, M., Aydın, E., Şenel, İ., & Yetkin, M. A. (2024) · Indian Journal of Medical Microbiology · doi:10.1016/j.ijmmb.2024.100536 · Cited by 3
Papanikou, S., Sideroglou, T., Chrysostomou, A., Kyritsi, M., Spaniolas, S., Bouboulis, D., Mouchtouri, V., & Mellou, K. (2023) · Foodborne pathogens and disease · doi:10.1089/fpd.2022.0057 · Cited by 5
“…, Plesiomonas shigelloides , Clostridium difficile [Toxin A/B], Salmonella spp., Cryptosporidium spp., Cy-clospora cayetanensis , Entamoeba histolytica , Giardia lamblia , Adenovirus F40/41, Astrovirus, Norovirus GI/GII, Rotavirus A and Sapovirus [genogroups I, II, IV and V]) (Buss et al, 2015).”
Replacement of Culture with Molecular Testing for Diagnosis Infectious Diseases.
Capraro, G. A. (2022) · Clinics in Laboratory Medicine · doi:10.1016/j.cll.2022.09.010 · Cited by 5
Tsilipounidaki, K., Florou, Z., Lianou, D. T., Michael, C. K., Katsarou, E., Skoulakis, A., Fthenakis, G., & Petinaki, E. (2022) · Microorganisms · doi:10.3390/microorganisms10040714 · Cited by 5
“[7] evaluated the technology in a collection of 1556 faecal sam‐ ples, by comparing its findings against results obtained by conventional faecal cultures and molecular methods.”
BackgroundResultImproving Care for Children with Bloody Diarrhea at Risk for Hemolytic Uremic Syndrome
Burns, C. S., Rubin, J., Sardesai, T., Klein, E. J., Vora, S. B., Kearney, R., & Rutman, L. (2022) · Pediatric Quality and Safety · doi:10.1097/pq9.0000000000000517 · Cited by 4
Diagnostic syndromic multiplex approaches for gastrointestinal infections
Maldonado-Garza, H. J., Garza‐González, E., Bocanegra‐Ibarias, P., & Flores-Treviño, S. (2021) · Expert Review of Gastroenterology & Hepatology · doi:10.1080/17474124.2021.1899807 · Cited by 4
Camargo, T., Silva, M., Camargo, L. F., Biotto, V. P., Doi, A., Koga, P., França, C., & Martino, M. (2021) · Archives of Microbiology · doi:10.1007/s00203-020-02148-8 · Cited by 5
Tisdale, M. D., Mitra, I., Mccoy, A. J., Simons, M., Reynolds, N. D., Swierczewski, B., Liu, J., Houpt, E., Fraser, J. A., Riddle, M., et al. (2020) · BMC Research Notes · doi:10.1186/s13104-020-05340-7 · Cited by 5
Molecular and non-molecular approaches to etiologic diagnosis of gastroenteritis
Zhang, X., Das, S., Dunbar, S. A., & Tang, Y. (2020) · Advances in clinical chemistry · doi:10.1016/bs.acc.2020.02.007 · Cited by 7
Tarr, G. A. M., Lin, C. Y., Vandermeer, B., Lorenzetti, D., Tarr, P. I., Chui, L., Hartling, L., & Freedman, S. B. (2020) · Clinical Chemistry · doi:10.1093/clinchem/hvz006 · Cited by 6
Tarr, G. A. M., Lin, C. Y., Lorenzetti, D., Chui, L., Tarr, P. I., Hartling, L., Vandermeer, B., & Freedman, S. B. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-025950 · Cited by 6
Point-of-Care Diagnostics for Infectious Diseases: Present and Future
Kim, S., & Shin, J. (2018) · Korean Journal of Medicine · doi:10.3904/kjm.2018.93.2.181 · Cited by 5
Headrick, A., Schmit, E., & Kimberlin, D. (2017) · The Pediatric Infectious Disease Journal · doi:10.1097/inf.0000000000001758 · Cited by 5
Kamidani, S., Melgar, M. A., Robinson, C., Asturias, E., Berman, S., & Gaensbauer, J. T. (2017) · The Pediatric Infectious Disease Journal · doi:10.1097/inf.0000000000001756 · Cited by 5
Cleary, O., McNerney, R., Yandle, Z., & O'Sullivan, C. (2017) · British Journal of Biomedical Science · doi:10.1080/09674845.2017.1278886 · Cited by 5
Host Range of Cyclospora Species: Zoonotic Implication
Solarczyk, P. (2021) · Acta Protozoologica · doi:10.4467/16890027ap.21.002.14062 · Cited by 5
Shu, J. H., Wang, H., Misra, A., Rhoads, D. D., Nowacki, A. S., Dalton, J. E., & Deshpande, A. (2025) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2025.08.008 · Cited by 4
Kinzler, A., Wikswo, M. E., Balasubramani, G., D'Agostino, H., Sax, T. M., Dauer, K., Weinberg, G. A., Szilyagi, P., Sahni, L. C., Boom, J., et al. (2025) · Journal of Clinical Virology · doi:10.1016/j.jcv.2025.105822 · Cited by 4
Enteropathogenic Escherichia coli (EPEC) Causes Chronic Diarrhea and Hyponatremia in an Adult
Chen, S., & Feuille, C. (2025) · Clinical Case Reports · doi:10.1002/ccr3.70288 · Cited by 4
“For example, the BioFire Film Array Gastrointestinal Panel (GIP) (BioFire Diagnostics, Salt Lake City, UT) offers a multiplex PCR assay that screens diarrheal samples for 22 enteric pathogens [2].”
InfluentialFactors Associated With Actionable Gastrointestinal Panel Results in Hospitalized Children
Ho, E. C., Cotter, J. M., Thomas, J. F., Birkholz, M. C., & Dominguez, S. R. (2023) · Hospital Pediatrics · doi:10.1542/hpeds.2023-007273 · Cited by 3
Shrateh, O. N., Jobran, A. W. M., Zaid, M. A., & Saleh, M. (2023) · The Pan African Medical Journal · doi:10.11604/pamj.2023.45.10.39548 · Cited by 4
“Additionally, analyses point to the possibility that transplant recipients may experience prolonged viral shedding after infection, which could result in PCR tests having better sensitivity than it would in the general population.”
MethodInfluentialKorhonen, L., Cohen, J. A., Gregoricus, N., Farley, M., Perlmutter, R., Holzbauer, S., Dumyati, G., Beldavs, Z., Paulick, A. L., Vinjé, J., et al. (2020) · PLoS ONE · doi:10.1371/journal.pone.0240549 · Cited by 4
“However, one of these studies had a small sample of only seven CDI cases [10], limiting its generalizability, and three other studies included children <2 years of age [5, 9, 11], who can have high prevalence of C.”
BackgroundAre CMV-predictive scores in inflammatory bowel disease useful in clinical practice?
Störkmann, H., Rödel, J., Stallmach, A., & Reuken, P. (2020) · Zeitschrift für Gastroenterologie - German Journal of Gastroenterology · doi:10.1055/a-1221-5463 · Cited by 4
“When combining these tests with rapid multiplex-PCR to rule out gastrointestinal infections, the first decision whether a patient requires anti-infective or immunosuppressive therapy can be made within several hours [13].”
MethodDevelopment of a Mobile Laboratory for Sudden Onset Disasters
Marr, I., Francis, J., Stephens, D., Marshall, K., Read, D. J., Baird, R., & Coatsworth, N. (2020) · Disaster Medicine and Public Health Preparedness · doi:10.1017/dmp.2019.128 · Cited by 4
Nycz, B., Pretty, K., Gomez-Trujillo, A., Sanchez, B., & Dominguez, S. (2019) · Journal of the Pediatric Infectious Diseases Society · doi:10.1093/jpids/piz081 · Cited by 4
Kreiniz, N., Abu-Ahmad, A., Golan-Shany, O., Paz, A., & Tadmor, T. (2019) · Acta Haematologica · doi:10.1159/000498906 · Cited by 4
Metadata
- Authors
- Buss, S. N., Leber, A., Chapin, K., Fey, P. D., Bankowski, M. J., Jones, M. K., Rogatcheva, M., Kanack, K. J., & Bourzac, K. M.
- Affiliations
- University of Nebraska Medical Center (US)
- Nationwide Children's Hospital (US)
- Lifespan (US)
- University of Hawaiʻi at Mānoa (US)
- BioFire Diagnostics (United States) (US)
- Venue
- Journal of Clinical Microbiology
- Publisher
- American Society for Microbiology
- Published
- 2015-03
- Volume
- 53
- Issue
- 3
- Pages
- 915-925
- ISSN
- 0095-1137 (ISSN-L)
- 1098-660X
- PMC
- PMC4390666
- OpenAlex
- W2169792847
- Cited by
- 554
- References
- 0
- Citations by year
- 2026: 43 · 2025: 46 · 2024: 42 · 2023: 62 · 2022: 43 · 2021: 51 · 2020: 61 · 2019: 41 · 2018: 58 · 2017: 48 · 2016: 39 · 2015: 18
- FWCI
- 42.22
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Microbiology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- BioFire Diagnostics
- National Institutes of Health
- National Institute of Allergy and Infectious Diseases (R01AI104593, R01AI089489)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Viral gastroenteritis research and epidemiology
- Health Sciences › Medicine › Microbiology (medical) › Bacterial Identification and Susceptibility Testing
- Life Sciences › Agricultural and Biological Sciences › Food Science › Salmonella and Campylobacter epidemiology
- Keywords
- infectious gastroenteritis, enteric pathogens, multiplex PCR, sensitivity and specificity, diarrheagenic Escherichia coli, norovirus, rotavirus, sapovirus, Cryptosporidium, Giardia lamblia, Shiga toxin-producing Escherichia coli, rapid molecular diagnostics
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Animals, Bacteria, Child, Child, Preschool, Feces, Female, Gastroenteritis, Humans, Infant, Infant, Newborn, Male, Microbiological Techniques, Middle Aged, Parasites, Prospective Studies, Sensitivity and Specificity, Time Factors, Viruses, Molecular Diagnostic Techniques, Young Adult
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