Among so many doubts about the disease, ensuring the quality of the reports of SARS-CoV2 exams is fundamental for combating Covid-19
More than a year after the notification of the first cases, the disease continues to provoke innumerable questions and, in this scenario, the diagnostic laboratories have a fundamental role in helping the answers.
To facilitate the management of the analytical phase processes and to insert the required reliability into the routine, Controllab offers complete solutions for the quality control of exams related to Covid-19, from validation to routine monitoring. See some of the solutions available:
Performance Panel: Used to evaluate and validate new test methods and equipment, the service demonstrates the reliability of the systems. Composed of positive and negative items, with varied concentrations and heterologous items obtained from different donors in the regions of Brazil, this panel is previously valued by different analysis methodologies.
Batch-to-batch validation/Shipping: Checks the proximity of results obtained with the new batch and the current batch to detect any significant deviations in the performance of the reagent and, then, define whether there is a need for a replacement of the reagent batch.
Linearity: analyzes the ability of the method to generate results linearly proportional to the concentration of the analyte.
Proficiency Testing (PT): also known as External Quality Control (EQC), is an effective quality control tool for determining the analytical performance of the laboratory.
Internal Control (IC): is responsible for the continuous monitoring of the reproducibility of the laboratory analytical phase.
Exam | Methodology | Samples | Tests | Performance Panel | Batch-to-batch Validation | Linearity | Proficiency Test | Internal Control |
|---|---|---|---|---|---|---|---|---|
| SARS-Cov2 (Nasopharynx, Oropharynx) | Molecular Biology by the polymerase chain reaction method with reverse transcription (RT-PCR) | Inactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genome | Identification of genes E, RdRp, N, N1, N2, ORF1ab, S and ORF3a | — | — | |||
| SARS-Cov2 (Saliva) | Molecular Biology RT-PCR and RT-LAMP | inactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genome or lyophilized human saliva | Identification of genes E, RdRp, N, N1, N2, ORF1ab, S and ORF3a | — | — | — | ||
| SARS-Cov2 | Automation Immunology by enzyme immunoassay, immunofluorescence, electrochemiluminescence, microparticles by chemiluminescence | Items for lyophilized human serum from a single or more donors | IIgG, IgM, IgA, Total and Avidity of IgG | — | — | |||
| SARS-Cov2 | Immunology RDT by immunochromatography and immunofluorescence | Items for lyophilized human serum from a single or more donors | IgG, IgM and Total | — | — | |||
| SARS-Cov2 Nasopharynx, Oropharynx and Saliva) | Antigen | Inactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genome | Identification | — | — | — | ||
| SARS-Cov2 | Molecular RDT for isothermal amplification | Inactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genome | Identification | — | — | — | — | |
| SARS-Cov2 (Foods | Molecular Biology by the polymerase chain reaction method with reverse transcription (RT-PCR) | Inactivated cell suspension items, lyophilized and prepared from viral isolation containing the complete SARS-CoV2 genome | Identification | — | — | — | available | — |
| Neutralizing Antibody Research | Automation | Items for lyophilized human serum from a single donor | Identification, Value and Inhibition Rate % | — | — | — | — | |
| Neutralizing Antibody Research | RDT | Items for lyophilized human serum from a single donor | Identification, Value and Inhibition Rate % | — | — | — | — |
In addition to these tools, Controllab provides Instrument Calibration, which is essential to reduce costs and rework, increase productivity and avoid errors in analytical processes.
Insert Controllab solutions into your routine and show your audience the reliability of your analyzes. To learn more, access the website, contact us by email contato@controllab.com or by phone and WhatsApp +55 (21) 97901-0310 and +55 (21) 98036-1592.
