Resources
Publications & Clinical Evidence
Our testing methodologies are backed by peer-reviewed research, including a registered, multicenter randomized controlled trial of 773 patients comparing DocLab 2.0 UTM PCR to culture-guided management of complicated UTIs (NCT06996301). The trial's results are published across several peer-reviewed papers, listed below, much of it authored by our own scientific leadership.
The randomized trial
The core evidence base — a multicenter, randomized, investigator-blinded trial (NCT06996301) and its secondary analyses.
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Why PCR Improves Outcomes: Faster Antibiotics, Better Choices
How PCR-guided management changes clinical symptom resolution in complicated UTI, and what mediates the benefit.
The strongest patient-outcome paper in the set. It doesn't just show PCR works — it shows why: roughly three-quarters of the benefit comes from starting the right antibiotic sooner.
Key findings
- Median time to first antibiotic: 20 h (IQR 12–36) vs. 52 h (IQR 30–66), p < 0.001
- Appropriate antibiotic chosen: 83.4% (161/193) vs. 62.1% (105/169), p < 0.001
- Complete clinical cure: 74.1% (143/193) vs. 62.7% (106/169), p = 0.020
- Partial cure (≥50% symptom reduction): 83.4% vs. 71.6%, p = 0.014
- Adjusted odds ratio for cure 1.95 (95% CI 1.12–3.39, p = 0.018)
- Approximately 74% of the benefit mediated through faster antibiotics and better initial choice
- Authors
- Priestly, I.P.; Chavez, R.; Derrick, D.; Huard, T.K.
- Trial
- NCT06996301 · 362 participants (PCR n = 193, culture n = 169)
Read the paper 10.3390/diagnostics15243107Full citation
Priestly, I.P.; Chavez, R.; Derrick, D.; Huard, T.K. Clinical Symptom Resolution Following PCR-Guided vs. Culture and Susceptibility-Guided Management of Complicated UTI: How Time-To-Antibiotic Start and Antibiotic Appropriateness Mediate the Benefit of Multiplex PCR—An Ad Hoc Analysis of NCT06996301. Diagnostics 2025, 15(24), 3107.
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Predicting Antibiotic Resistance from PCR: Genotype–Phenotype Concordance
Whether resistance genes detected by PCR reliably predict actual phenotypic resistance, and what that means for stewardship.
Establishes the scientific basis for acting on a PCR resistance result before susceptibility testing comes back.
Key findings
- blaCTX-M in E. coli: sensitivity 0.94 (95% CI 0.88–0.97), specificity 0.995 (95% CI 0.990–0.998), κ ≈ 0.93
- Median time to antibiotic: 20 h (PCR) vs. 52 h (culture)
- Treatment success: 88.1% vs. 78.1% — adjusted odds ratio 1.95 (95% CI 1.12–3.40, p = 0.018)
- 63% of the treatment-success benefit was mediated by earlier antibiotic initiation
- ROC AUC 0.62–0.81 for ΔCt predicting non-susceptibility
- Authors
- Priestly, I.P.; Chavez, R.; Derrick, D.; Huard, T.K.
- Trial
- NCT06996301 · PCR arm n = 193, culture arm n = 169
Read the paper 10.3390/diagnostics15232945Full citation
Priestly, I.P.; Chavez, R.; Derrick, D.; Huard, T.K. Genotype–Phenotype Concordance and Ct-Informed Predictive Rules for Antimicrobial Resistance in Adult Patients with Complicated Urinary Tract Infections: Clinical and Stewardship Implications from the NCT06996301 Trial. Diagnostics 2025, 15(23), 2945.
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Reading Bacterial Load from PCR: ΔCt Thresholds and Specimen Handling
Whether PCR signal tracks bacterial load, and what actually explains PCR-positive / culture-negative discordance.
Answers the most common objection to PCR — that it detects dead DNA. Most discordance turns out to be explained by specimen handling delay, not false positives.
Key findings
- PCR positivity 82–88% vs. culture 66–70% across all six sites
- ΔCt correlated strongly with bacterial load (Spearman ρ −0.64 to −0.75; Pearson r −0.75 to −0.83)
- Each 1-unit ΔCt change ≈ a 5.6–8.4-fold difference in CFU
- ROC AUC 0.78–0.84 for discriminating high bacterial load
- Processing delay cost ~0.048 log₁₀CFU per hour — time-dependent viability loss drives the discordance
- Collection method (catheter vs. clean-catch) did not materially affect the relationship
- Authors
- Priestly, I.P.; Chavez, R.; Derrick, D.; Huard, T.K.
- Trial
- NCT06996301 · 1,027 paired specimens across 6 sites
Read the paper 10.3390/diagnostics15232959Full citation
Priestly, I.P.; Chavez, R.; Derrick, D.; Huard, T.K. Semi-Quantitative ΔCt Thresholds for Bacteriuria and Pre-Analytic Drivers of PCR-Culture Discordance in Complicated UTI: An Analysis of NCT06996301. Diagnostics 2025, 15(23), 2959.
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What Culture Misses: Polymicrobial Infection, Resistance, and Treatment Failure
A secondary analysis of pathogen detection, resistance profiles, and their impact on clinical outcomes.
The clearest evidence that culture's blind spots have real consequences for patients. When culture missed a polymicrobial infection, treatment failed half again as often.
Key findings
- PCR identified polymicrobial infection in 43.52% of cases vs. 31.95% for culture (p = 0.033)
- Missed polymicrobial infection → clinical failure in 33.33% (14/42) vs. 22.22% (12/54) when both methods agreed (p = 0.041)
- PCR found additional pathogens in 54.44% (92/169) of culture-arm cases; failure 28.26% vs. 14.29% when culture missed pathogens (p = 0.015)
- When culture missed phenotypic resistance, failure hit 50% (16/42) vs. 13.22% (21/121) when both agreed (p = 0.001)
- Authors
- Kardjadj, M.; Chang, T.W.; Chavez, R.; Derrick, D.; Spangler, F.L.; Priestly, I.P.; Park, L.Y.; Huard, T.K.
- Design
- Multicenter, randomized, investigator-blinded
Read the paper 10.3390/microorganisms13040949Full citation
Kardjadj, M.; Chang, T.W.; Chavez, R.; Derrick, D.; Spangler, F.L.; Priestly, I.P.; Park, L.Y.; Huard, T.K. The clinical validity and utility of PCR compared to conventional culture and sensitivity testing for the management of complicated urinary tract infections in adults: A secondary (ad hoc) analysis of pathogen detection, resistance profiles, and impact on clinical outcomes. Microorganisms 2025, 13(4), 949.
The two-part clinical series
Published back-to-back in Diagnostic Microbiology and Infectious Disease. Part I covers outcomes and turnaround; Part II covers diagnostic agreement and antibiotic choice.
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PCR vs. Culture in Complicated UTI — Part I: Clinical Outcomes and Turnaround Time
Clinical outcomes, investigator satisfaction scores, and turnaround times when PCR replaces conventional culture and sensitivity testing for complicated UTI in adults.
- Authors
- Spangler, F.L.; Williams, C.; Aberger, M.E.; Wilson, B.A.; Ajib, K.; Gholami, S.S.; Goodwin, H.N.; Park, L.Y.; Kardjadj, M.; Derrick, D.; et al.
Read the paper PMID 39532029Full citation
Spangler, F.L.; Williams, C.; Aberger, M.E.; Wilson, B.A.; Ajib, K.; Gholami, S.S.; Goodwin, H.N.; Park, L.Y.; Kardjadj, M.; Derrick, D.; et al. Clinical utility of PCR compared to conventional culture and sensitivity testing for the management of complicated urinary tract infections in adults: Part I: Assessment of clinical outcomes, investigator satisfaction scores, and turnaround times. Diagn. Microbiol. Infect. Dis. 2025, 111, 116601.
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PCR vs. Culture in Complicated UTI — Part II: Diagnostic Concordance and Antibiotic Selection
How often PCR and culture agree, what drives the cases where they disagree, and whether PCR leads to better antimicrobial selection.
- Authors
- Spangler, F.L.; Williams, C.; Aberger, M.E.; Wilson, B.A.; Ajib, K.; Gholami, S.S.; Goodwin, H.N.; Park, L.Y.; Kardjadj, M.; Derrick, D.; et al.
Read the paper PMID 39671979Full citation
Spangler, F.L.; Williams, C.; Aberger, M.E.; Wilson, B.A.; Ajib, K.; Gholami, S.S.; Goodwin, H.N.; Park, L.Y.; Kardjadj, M.; Derrick, D.; et al. Clinical utility of PCR compared to conventional culture and sensitivity testing for management of complicated urinary tract infections in adults: Part II: Evaluation of diagnostic concordance, discordant results, and antimicrobial selection efficacy. Diagn. Microbiol. Infect. Dis. 2025, 111, 116646.
Reviews and commentary
Broader syntheses, including the paper addressing MolDX coverage criteria directly — the most useful one for practices in restricted states.
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PCR vs. Culture for Complicated UTI: Evidence Review and MolDX Coverage Criteria
A synthesis of real-world evidence, clinical trials, and meta-analyses examined specifically against Molecular Diagnostic Services (MolDX) program coverage criteria.
The most directly useful paper for practices in MolDX-restricted states, and the natural citation for our MolDX guidance work.
- Authors
- Aberger, M.E.; Wilson, B.A.; Chavez, R.
Read the paper reviewsinurology.comFull citation
Aberger, M.E.; Wilson, B.A.; Chavez, R. Evaluating the analytical validity and clinical utility and validity of polymerase chain reaction diagnostics vs culture and sensitivity methods in complicated urinary tract infection management: A comprehensive review of real-world evidence, clinical trials, and meta-analyses concerning molecular diagnostic services program coverage criteria. Rev. Urol. 2025, 24, 1–11.
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PCR in Complicated UTI: A Paradigm Shift in Diagnostics and Management
A commentary framing the shift from culture-based to molecular diagnosis in complicated UTI, published in the AUA's open-access journal.
- Authors
- Kardjadj, M.
Read the paper 10.1097/JU9.0000000000000353Full citation
Kardjadj, M. Clinical Utility of PCR in Complicated Urinary Tract Infections: A Paradigm Shift in Diagnostics and Management. JU Open Plus 2025, 3, e00114.
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Diagnostic Stewardship for Urinary Tract Infection in the United States: Why Evidence Must Drive Syndromic Panel Adoption
- Authors
- Kardjadj, M.
- Design
- Editorial
Read the paper 10.1097/UPJ.0000000000001032Full citation
Kardjadj M. Diagnostic Stewardship for Urinary Tract Infection in the United States: Why Evidence Must Drive Syndromic Panel Adoption. Urology Practice. 2026;13(5):459–63.
Available on request: info@doclabinc.com
MiCheck® Prostate: the MiCheck-01 trial
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A comparison of prostate health index, total PSA, %free PSA, and proPSA in a contemporary US population—The MiCheck-01 prospective trial
- Authors
- Shore ND, Pieczonka CM, Henderson RJ, et al.
- Trial
- MiCheck-01
Read the paper 10.1016/j.urolonc.2020.03.011Full citation
Shore ND, Pieczonka CM, Henderson RJ, et al. A comparison of prostate health index, total PSA, %free PSA, and proPSA in a contemporary US population—The MiCheck-01 prospective trial. Urologic Oncology: Seminars and Original Investigations. 2020;38(8):683.e1–683.e10.
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Development and evaluation of the MiCheck test for aggressive prostate cancer
- Authors
- Shore ND, Pieczonka CM, Henderson RJ, et al.
- Trial
- MiCheck-01
Read the paper 10.1016/j.urolonc.2020.03.010Full citation
Shore ND, Pieczonka CM, Henderson RJ, et al. Development and evaluation of the MiCheck test for aggressive prostate cancer. Urologic Oncology: Seminars and Original Investigations. 2020;38(8):683.e11–683.e18.
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Development and evaluation of the MiCheck® Prostate test for clinically significant prostate cancer
- Authors
- Shore ND, Polikarpov DM, Pieczonka CM, et al.
- Trial
- MiCheck-01
Read the paper 10.1016/j.urolonc.2023.08.005Full citation
Shore ND, Polikarpov DM, Pieczonka CM, et al. Development and evaluation of the MiCheck® Prostate test for clinically significant prostate cancer. Urologic Oncology: Seminars and Original Investigations. 2023;41(11):454.e9–454.e16.
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Substitution of DRE result with patient age results in enhanced test performance for MiCheck® Prostate blood test for clinically significant prostate cancer
- Authors
- Shore ND, Polikarpov DM, Pieczonka CM, et al.
- Trial
- MiCheck-01
Full citation
Shore ND, Polikarpov DM, Pieczonka CM, et al. Substitution of DRE result with patient age results in enhanced test performance for MiCheck® Prostate blood test for clinically significant prostate cancer. Manuscript in preparation. 2026.
Available on request: info@doclabinc.com
The science
Interested in Our Research?
We're happy to walk you through the clinical evidence behind our testing, provide documentation on any of our tests, or discuss how your lab can participate in an upcoming trial.