ReviewClinical microbiology reviews2010
Validation of laboratory-developed molecular assays for infectious diseases.
Review in Clinical microbiology reviews, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 250 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
250 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Practical Guidance for Clinical Microbiology Laboratories: Viruses Causing Acute Respiratory Tract Infections.Clinical microbiology reviews · 2019Guideline
- Usefulness of Serial Blood Sampling and PCR Replicates for Treatment Monitoring of Patients with Chronic Chagas Disease.Antimicrobial agents and chemotherapy · 2019Trial
- A rapid approach to detect methicillin-resistant and susceptibleMicrobiology spectrum · 2026Article
- Article
- The CDC/APHL next generation sequencing quality initiative: practical guidance to implementing quality management systems in laboratories performing next generation sequencing (phase 2).Journal of clinical microbiology · 2026Review
- Validation of sample pooling for high-throughput RT-qPCR subtyping of avian influenza A(H5).Microbiology spectrum · 2026Article
- Diagnosis of chlamydial and gonococcal conjunctivitis: performance evaluation of a nucleic acid amplification test.Microbiology spectrum · 2026Article
- Integrating HTS and CRISPR/Cas for next-generation nucleic and non-nucleic acid diagnostics.Molecular genetics and genomics : MGG · 2026Review
- A LAMP-Assay for the Detection and Genotyping of HPV Causing Plantar Warts From Skin Scrapes Samples.Journal of medical virology · 2026Article
- Validation of a 2-Gene Blood Test for Kawasaki Disease in Febrile Children.JAMA network open · 2026Article
- Commercial Translation of Electrochemical Biosensors: Supply Chain Strategy, Scale-Up Manufacturing, and Regulatory-Quality Considerations.Biosensors · 2026Review
- Development and validation of a sample-to-result real time multiplex RT-PCR test for human African trypanosomiasis and arboviral febrile illnesses in the Democratic Republic of the Congo.BMC infectious diseases · 2026Observational
- The role of rapid molecular diagnostics in managing bloodstream infections: a microbiological insight.Folia microbiologica · 2026Review
- Validation of a multiplex qRT-PCR assay for the detection of RSV, influenza A/B virus and SARS-CoV-2.BMC microbiology · 2026Article
- Quantitative Real-Time PCR for Trypanosoma cruzi Infection Diagnosis and Treatment Response Monitoring of Patients with Chagas Disease.Methods in molecular biology (Clifton, N.J.) · 2026Article
- Real-Time PCR Assays for Quantification of Trypanosoma cruzi in Food Samples: A Tool for Surveillance of Oral Chagas Disease Outbreaks.Methods in molecular biology (Clifton, N.J.) · 2026Article
- CRISPR/Cas diagnostics forFrontiers in bioengineering and biotechnology · 2026Review
- A Review on the Current and Future State of Urinary Tract Infection Diagnostics.International journal of molecular sciences · 2025Review
- JC virus PCR assay reporting for PML: promises, perils, and pitfalls.Journal of neurology · 2025Review
- Sensitive near point-of-care detection of asymptomatic and submicroscopic Plasmodium falciparum infections in African endemic countries.Nature communications · 2025Article
190 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Molecular technology has changed the way that clinical laboratories diagnose and manage many infectious diseases. Excellent sensitivity, specificity, and speed have made molecular assays an attractive alternative to culture or enzyme immunoassay methods. Many molecular assays are commercially available and FDA approved. Others, especially those that test for less common analytes, are often laboratory developed. Laboratories also often modify FDA-approved assays to include different extraction systems or additional specimen types. The Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards require clinical laboratories to establish and document their own performance specifications for laboratory-developed tests to ensure accurate and precise results prior to implementation of the test. The performance characteristics that must be established include accuracy, precision, reportable range, reference interval, analytical sensitivity, and analytical specificity. Clinical laboratories are challenged to understand the requirements and determine the types of experiments and analyses necessary to meet the requirements. A variety of protocols and guidelines are available in various texts and documents. Many of the guidelines are general and more appropriate for assays in chemistry sections of the laboratory but are applied in principle to molecular assays. This review presents information that laboratories may consider in their efforts to meet regulatory requirements.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.