| Study Identifier . | Age/Sex . | Comorbidities . | Clinical Syndrome . | Karius Test Result (Molecules/μL) . | Clinical Impact per Treating Team . | Clinical Impact Type . | Detail . |
|---|---|---|---|---|---|---|---|
| SHC-11 | 57 y/M | HIV/AIDS, CAD, CKD | Suspected mycotic aneurysm | Enterococcus faecalis (344); Prevotella melaninogenica (176) | Positive | New diagnosis and de-escalation of therapy | Karius test result was used to de-escalate chronic suppressive therapy to amoxicillin-clavulanic acid, after a 6-wk course of empiric vancomycin and ceftriaxone. Nine months later, after multiple clinical recurrences, vertebral tissue biopsy grew MAC. |
| SHC-13 | 47 y/F | s/p combined heart and kidney transplant (2018) for anthracycline-induced cardiomyopathy, history of ALL | AFP | Aspergillus fumigatus (qualitative result) | None/ positive | None for AFP. Earlier diagnosis and initiation of therapy for fungal infection | Karius test identified Aspergillus fumigatus earlier than conventional methods and prompted chest imaging and respiratory cultures that confirmed invasive pulmonary aspergillosis. Serum galactomannan had been elevated (>2.00) in the week prior to Karius test. |
| UCLA-3 | 2 y/M | Idiopathic acute liver failure, aplastic anemia, HLH | Recurrent fever | Candida tropicalis (6670) | Positive | Earlier diagnosis and initiation of therapy | Karius test result was used to initiate antifungal therapy with caspofungin 5 d earlier than the time of diagnosis by blood culture. |
| UCLA-20 | 10 y/F | Liver/small bowel/colon/pancreas transplant (2018), TPN-dependent short gut syndrome | Jejunal perforation with necrotic fascia, subcutaneous abscess, perinephric fluid collection | Rhizopus oryzae (169 935); Stenotrophomonas maltophilia (2649); Escherichia coli (234) | Positive | New diagnosis not made by conventional methods and escalation of therapy | Karius test diagnosed invasive mucormycosis, which was not made through conventional methods and which enabled targeted antifungal therapy. The patient was not treated for the bacterial organisms detected. |
| UCLA-47 | 6 wk/M | Newborn by emergency cesarean delivery, TAPVR s/p repair | Multiorgan dysfunction syndrome, coagulopathy, respiratory failure | Negative | Positive | De-escalation of therapy | Karius test result was negative and supported the clinical suspicion that patient’s clinical decompensation was not infectious in etiology. This prompted discontinuation of empiric cefepime. |
| UT-2 | 75 y/M | Metastatic carcinoma of unknown primary | Multifocal abscesses (lung, liver, and kidney) | Streptococcus parasanguinis (372); Morococcus cerebrosus (212); Neisseria sicca (96); Veillonella parvula (64); Prevotella melaninogenica (36); Propionibacterium acidifaciens (24); EBV (23) | Positive | New diagnosis not made by conventional methods and de-escalation of therapy | Karius test identified mixed oral flora, which was consistent with a periodontal source of infection. This allowed narrowing of antibacterial therapy from vancomycin/piperacillin-tazobactam to amoxicillin-clavulanic acid for a total duration of 6 wk of therapy. |
| CUMC-5 | 17 y/F | GATA-2 MDS s/p PBSC transplant (2018) | Fever, buccal lesions, hepatic lesions | Trichosporon asahii (1786); Enterococcus faecium (1567); Mucor indicus (1199); CMV (763); Rhizopus delemar (107); Candida glabrata (75); Veillonella parvula (47) | Negative | Unnecessary treatment | Karius test result prompted additional antibacterial coverage that was not thought to be warranted per ID team. Patient was already known to have invasive mucormycosis. |
| SHC-8 | 39 y/F | CVID | Chronic low-grade fever | Prevotella bivia (23); Streptococcus pseudopneumoniae (23); Bacteroides fragilis (21) | Negative | Additional diagnostic investigations | Karius test result prompted an ED visit, and subsequent outpatient consultation with ID to outline management. The patient was not treated for the Karius test result. |
| SHC-14 | 20 y/M | Refractory and recurrent marginal cell MALT-like lymphoma of ileum and colon | Investigation of lymphoma etiology | Trichoderma atroviride (695); Enterobacter cloacae complex (96) | Negative | Additional diagnostic investigations | Karius test result prompted concern by the treating team about a false-positive result. Targeted fungal sequencing on plasma was performed to try to disprove result and was negative. The patient was not treated for the Karius test result. |
| Study Identifier . | Age/Sex . | Comorbidities . | Clinical Syndrome . | Karius Test Result (Molecules/μL) . | Clinical Impact per Treating Team . | Clinical Impact Type . | Detail . |
|---|---|---|---|---|---|---|---|
| SHC-11 | 57 y/M | HIV/AIDS, CAD, CKD | Suspected mycotic aneurysm | Enterococcus faecalis (344); Prevotella melaninogenica (176) | Positive | New diagnosis and de-escalation of therapy | Karius test result was used to de-escalate chronic suppressive therapy to amoxicillin-clavulanic acid, after a 6-wk course of empiric vancomycin and ceftriaxone. Nine months later, after multiple clinical recurrences, vertebral tissue biopsy grew MAC. |
| SHC-13 | 47 y/F | s/p combined heart and kidney transplant (2018) for anthracycline-induced cardiomyopathy, history of ALL | AFP | Aspergillus fumigatus (qualitative result) | None/ positive | None for AFP. Earlier diagnosis and initiation of therapy for fungal infection | Karius test identified Aspergillus fumigatus earlier than conventional methods and prompted chest imaging and respiratory cultures that confirmed invasive pulmonary aspergillosis. Serum galactomannan had been elevated (>2.00) in the week prior to Karius test. |
| UCLA-3 | 2 y/M | Idiopathic acute liver failure, aplastic anemia, HLH | Recurrent fever | Candida tropicalis (6670) | Positive | Earlier diagnosis and initiation of therapy | Karius test result was used to initiate antifungal therapy with caspofungin 5 d earlier than the time of diagnosis by blood culture. |
| UCLA-20 | 10 y/F | Liver/small bowel/colon/pancreas transplant (2018), TPN-dependent short gut syndrome | Jejunal perforation with necrotic fascia, subcutaneous abscess, perinephric fluid collection | Rhizopus oryzae (169 935); Stenotrophomonas maltophilia (2649); Escherichia coli (234) | Positive | New diagnosis not made by conventional methods and escalation of therapy | Karius test diagnosed invasive mucormycosis, which was not made through conventional methods and which enabled targeted antifungal therapy. The patient was not treated for the bacterial organisms detected. |
| UCLA-47 | 6 wk/M | Newborn by emergency cesarean delivery, TAPVR s/p repair | Multiorgan dysfunction syndrome, coagulopathy, respiratory failure | Negative | Positive | De-escalation of therapy | Karius test result was negative and supported the clinical suspicion that patient’s clinical decompensation was not infectious in etiology. This prompted discontinuation of empiric cefepime. |
| UT-2 | 75 y/M | Metastatic carcinoma of unknown primary | Multifocal abscesses (lung, liver, and kidney) | Streptococcus parasanguinis (372); Morococcus cerebrosus (212); Neisseria sicca (96); Veillonella parvula (64); Prevotella melaninogenica (36); Propionibacterium acidifaciens (24); EBV (23) | Positive | New diagnosis not made by conventional methods and de-escalation of therapy | Karius test identified mixed oral flora, which was consistent with a periodontal source of infection. This allowed narrowing of antibacterial therapy from vancomycin/piperacillin-tazobactam to amoxicillin-clavulanic acid for a total duration of 6 wk of therapy. |
| CUMC-5 | 17 y/F | GATA-2 MDS s/p PBSC transplant (2018) | Fever, buccal lesions, hepatic lesions | Trichosporon asahii (1786); Enterococcus faecium (1567); Mucor indicus (1199); CMV (763); Rhizopus delemar (107); Candida glabrata (75); Veillonella parvula (47) | Negative | Unnecessary treatment | Karius test result prompted additional antibacterial coverage that was not thought to be warranted per ID team. Patient was already known to have invasive mucormycosis. |
| SHC-8 | 39 y/F | CVID | Chronic low-grade fever | Prevotella bivia (23); Streptococcus pseudopneumoniae (23); Bacteroides fragilis (21) | Negative | Additional diagnostic investigations | Karius test result prompted an ED visit, and subsequent outpatient consultation with ID to outline management. The patient was not treated for the Karius test result. |
| SHC-14 | 20 y/M | Refractory and recurrent marginal cell MALT-like lymphoma of ileum and colon | Investigation of lymphoma etiology | Trichoderma atroviride (695); Enterobacter cloacae complex (96) | Negative | Additional diagnostic investigations | Karius test result prompted concern by the treating team about a false-positive result. Targeted fungal sequencing on plasma was performed to try to disprove result and was negative. The patient was not treated for the Karius test result. |
Abbreviations: AFP, acute flaccid paralysis; ALL, acute lymphoblastic leukemia; CAD, coronary artery disease; CKD, chronic kidney disease; CMV, cytomegalovirus; CUMC, Columbia University Medical Center; CVID, common variable immunodeficiency; EBV, Epstein-Barr virus; ED, emergency department; F, female; GATA-2, GATA-2 gene; HIV, human immunodeficiency virus; HLH, hemophagocytic lymphohistiocytosis; ID, infectious diseases; M, male; MAC, Mycobacterium avium complex; MALT, mucosa-associated lymphoid tissue; MDS, myelodysplastic syndrome; PBSC, peripheral blood stem cell; SHC, Stanford Health Care; s/p, status post; TAPVR, total anomalous pulmonary venous return; TPN, total parenteral nutrition; UCLA, University of California, Los Angeles; UT, University of Utah.
| Study Identifier . | Age/Sex . | Comorbidities . | Clinical Syndrome . | Karius Test Result (Molecules/μL) . | Clinical Impact per Treating Team . | Clinical Impact Type . | Detail . |
|---|---|---|---|---|---|---|---|
| SHC-11 | 57 y/M | HIV/AIDS, CAD, CKD | Suspected mycotic aneurysm | Enterococcus faecalis (344); Prevotella melaninogenica (176) | Positive | New diagnosis and de-escalation of therapy | Karius test result was used to de-escalate chronic suppressive therapy to amoxicillin-clavulanic acid, after a 6-wk course of empiric vancomycin and ceftriaxone. Nine months later, after multiple clinical recurrences, vertebral tissue biopsy grew MAC. |
| SHC-13 | 47 y/F | s/p combined heart and kidney transplant (2018) for anthracycline-induced cardiomyopathy, history of ALL | AFP | Aspergillus fumigatus (qualitative result) | None/ positive | None for AFP. Earlier diagnosis and initiation of therapy for fungal infection | Karius test identified Aspergillus fumigatus earlier than conventional methods and prompted chest imaging and respiratory cultures that confirmed invasive pulmonary aspergillosis. Serum galactomannan had been elevated (>2.00) in the week prior to Karius test. |
| UCLA-3 | 2 y/M | Idiopathic acute liver failure, aplastic anemia, HLH | Recurrent fever | Candida tropicalis (6670) | Positive | Earlier diagnosis and initiation of therapy | Karius test result was used to initiate antifungal therapy with caspofungin 5 d earlier than the time of diagnosis by blood culture. |
| UCLA-20 | 10 y/F | Liver/small bowel/colon/pancreas transplant (2018), TPN-dependent short gut syndrome | Jejunal perforation with necrotic fascia, subcutaneous abscess, perinephric fluid collection | Rhizopus oryzae (169 935); Stenotrophomonas maltophilia (2649); Escherichia coli (234) | Positive | New diagnosis not made by conventional methods and escalation of therapy | Karius test diagnosed invasive mucormycosis, which was not made through conventional methods and which enabled targeted antifungal therapy. The patient was not treated for the bacterial organisms detected. |
| UCLA-47 | 6 wk/M | Newborn by emergency cesarean delivery, TAPVR s/p repair | Multiorgan dysfunction syndrome, coagulopathy, respiratory failure | Negative | Positive | De-escalation of therapy | Karius test result was negative and supported the clinical suspicion that patient’s clinical decompensation was not infectious in etiology. This prompted discontinuation of empiric cefepime. |
| UT-2 | 75 y/M | Metastatic carcinoma of unknown primary | Multifocal abscesses (lung, liver, and kidney) | Streptococcus parasanguinis (372); Morococcus cerebrosus (212); Neisseria sicca (96); Veillonella parvula (64); Prevotella melaninogenica (36); Propionibacterium acidifaciens (24); EBV (23) | Positive | New diagnosis not made by conventional methods and de-escalation of therapy | Karius test identified mixed oral flora, which was consistent with a periodontal source of infection. This allowed narrowing of antibacterial therapy from vancomycin/piperacillin-tazobactam to amoxicillin-clavulanic acid for a total duration of 6 wk of therapy. |
| CUMC-5 | 17 y/F | GATA-2 MDS s/p PBSC transplant (2018) | Fever, buccal lesions, hepatic lesions | Trichosporon asahii (1786); Enterococcus faecium (1567); Mucor indicus (1199); CMV (763); Rhizopus delemar (107); Candida glabrata (75); Veillonella parvula (47) | Negative | Unnecessary treatment | Karius test result prompted additional antibacterial coverage that was not thought to be warranted per ID team. Patient was already known to have invasive mucormycosis. |
| SHC-8 | 39 y/F | CVID | Chronic low-grade fever | Prevotella bivia (23); Streptococcus pseudopneumoniae (23); Bacteroides fragilis (21) | Negative | Additional diagnostic investigations | Karius test result prompted an ED visit, and subsequent outpatient consultation with ID to outline management. The patient was not treated for the Karius test result. |
| SHC-14 | 20 y/M | Refractory and recurrent marginal cell MALT-like lymphoma of ileum and colon | Investigation of lymphoma etiology | Trichoderma atroviride (695); Enterobacter cloacae complex (96) | Negative | Additional diagnostic investigations | Karius test result prompted concern by the treating team about a false-positive result. Targeted fungal sequencing on plasma was performed to try to disprove result and was negative. The patient was not treated for the Karius test result. |
| Study Identifier . | Age/Sex . | Comorbidities . | Clinical Syndrome . | Karius Test Result (Molecules/μL) . | Clinical Impact per Treating Team . | Clinical Impact Type . | Detail . |
|---|---|---|---|---|---|---|---|
| SHC-11 | 57 y/M | HIV/AIDS, CAD, CKD | Suspected mycotic aneurysm | Enterococcus faecalis (344); Prevotella melaninogenica (176) | Positive | New diagnosis and de-escalation of therapy | Karius test result was used to de-escalate chronic suppressive therapy to amoxicillin-clavulanic acid, after a 6-wk course of empiric vancomycin and ceftriaxone. Nine months later, after multiple clinical recurrences, vertebral tissue biopsy grew MAC. |
| SHC-13 | 47 y/F | s/p combined heart and kidney transplant (2018) for anthracycline-induced cardiomyopathy, history of ALL | AFP | Aspergillus fumigatus (qualitative result) | None/ positive | None for AFP. Earlier diagnosis and initiation of therapy for fungal infection | Karius test identified Aspergillus fumigatus earlier than conventional methods and prompted chest imaging and respiratory cultures that confirmed invasive pulmonary aspergillosis. Serum galactomannan had been elevated (>2.00) in the week prior to Karius test. |
| UCLA-3 | 2 y/M | Idiopathic acute liver failure, aplastic anemia, HLH | Recurrent fever | Candida tropicalis (6670) | Positive | Earlier diagnosis and initiation of therapy | Karius test result was used to initiate antifungal therapy with caspofungin 5 d earlier than the time of diagnosis by blood culture. |
| UCLA-20 | 10 y/F | Liver/small bowel/colon/pancreas transplant (2018), TPN-dependent short gut syndrome | Jejunal perforation with necrotic fascia, subcutaneous abscess, perinephric fluid collection | Rhizopus oryzae (169 935); Stenotrophomonas maltophilia (2649); Escherichia coli (234) | Positive | New diagnosis not made by conventional methods and escalation of therapy | Karius test diagnosed invasive mucormycosis, which was not made through conventional methods and which enabled targeted antifungal therapy. The patient was not treated for the bacterial organisms detected. |
| UCLA-47 | 6 wk/M | Newborn by emergency cesarean delivery, TAPVR s/p repair | Multiorgan dysfunction syndrome, coagulopathy, respiratory failure | Negative | Positive | De-escalation of therapy | Karius test result was negative and supported the clinical suspicion that patient’s clinical decompensation was not infectious in etiology. This prompted discontinuation of empiric cefepime. |
| UT-2 | 75 y/M | Metastatic carcinoma of unknown primary | Multifocal abscesses (lung, liver, and kidney) | Streptococcus parasanguinis (372); Morococcus cerebrosus (212); Neisseria sicca (96); Veillonella parvula (64); Prevotella melaninogenica (36); Propionibacterium acidifaciens (24); EBV (23) | Positive | New diagnosis not made by conventional methods and de-escalation of therapy | Karius test identified mixed oral flora, which was consistent with a periodontal source of infection. This allowed narrowing of antibacterial therapy from vancomycin/piperacillin-tazobactam to amoxicillin-clavulanic acid for a total duration of 6 wk of therapy. |
| CUMC-5 | 17 y/F | GATA-2 MDS s/p PBSC transplant (2018) | Fever, buccal lesions, hepatic lesions | Trichosporon asahii (1786); Enterococcus faecium (1567); Mucor indicus (1199); CMV (763); Rhizopus delemar (107); Candida glabrata (75); Veillonella parvula (47) | Negative | Unnecessary treatment | Karius test result prompted additional antibacterial coverage that was not thought to be warranted per ID team. Patient was already known to have invasive mucormycosis. |
| SHC-8 | 39 y/F | CVID | Chronic low-grade fever | Prevotella bivia (23); Streptococcus pseudopneumoniae (23); Bacteroides fragilis (21) | Negative | Additional diagnostic investigations | Karius test result prompted an ED visit, and subsequent outpatient consultation with ID to outline management. The patient was not treated for the Karius test result. |
| SHC-14 | 20 y/M | Refractory and recurrent marginal cell MALT-like lymphoma of ileum and colon | Investigation of lymphoma etiology | Trichoderma atroviride (695); Enterobacter cloacae complex (96) | Negative | Additional diagnostic investigations | Karius test result prompted concern by the treating team about a false-positive result. Targeted fungal sequencing on plasma was performed to try to disprove result and was negative. The patient was not treated for the Karius test result. |
Abbreviations: AFP, acute flaccid paralysis; ALL, acute lymphoblastic leukemia; CAD, coronary artery disease; CKD, chronic kidney disease; CMV, cytomegalovirus; CUMC, Columbia University Medical Center; CVID, common variable immunodeficiency; EBV, Epstein-Barr virus; ED, emergency department; F, female; GATA-2, GATA-2 gene; HIV, human immunodeficiency virus; HLH, hemophagocytic lymphohistiocytosis; ID, infectious diseases; M, male; MAC, Mycobacterium avium complex; MALT, mucosa-associated lymphoid tissue; MDS, myelodysplastic syndrome; PBSC, peripheral blood stem cell; SHC, Stanford Health Care; s/p, status post; TAPVR, total anomalous pulmonary venous return; TPN, total parenteral nutrition; UCLA, University of California, Los Angeles; UT, University of Utah.
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