STANDARD PROTOCOL FOR EVALUATION OF MOLECULAR TEST ASSAYS FOR THE DETECTION OF PATHOGENS

(RECOMMENDED TO BE PERFORMED BY END-USER LABORATORIES PRIOR TO USE IN ROUTINE DIAGNOSTICS) version 12 October 2022 Accuracy, precision, sensitivity, and specificity are some examples of assay performance characteristics described by the Clinical and Laboratory Standards Institute (CLSI) as properties of a test that is used to describe its quality. Accuracy is defined as the continue reading : STANDARD PROTOCOL FOR EVALUATION OF MOLECULAR TEST ASSAYS FOR THE DETECTION OF PATHOGENS

Interim Laboratory Biosafety Guidelines for Handling and Processing Suspected Monkeypox Specimens

Cases of Monkeypox have been recently detected in countries that are not endemic for its actiologic agent – the Monkeypox virus. Monkeypox virus is an enveloped double-stranded DNA virus (Orthopoxvirus genus of the Poxviridae family). Monkeypox virus belongs to the genus that includes variola virus/smallpox vaccinia virus, and cowpox virus. Monkeypox virus is a Risk continue reading : Interim Laboratory Biosafety Guidelines for Handling and Processing Suspected Monkeypox Specimens

PROCEDURE FOR DMPC TREATMENT OF GLASSWARE AND PLASTICWARE

Techniques and experiments in molecular biology employed in the study of infectious diseases greatly rely on information obtained by studying the genetic material from pathogens or of infected individuals. It is important that the laboratory work areas are clean and free from nucleases that can degrade DNA or RNA. Aside from work areas, commonly used continue reading : PROCEDURE FOR DMPC TREATMENT OF GLASSWARE AND PLASTICWARE

UNDERSTANDING SARS-COV-2 RT-PCR TEST RESULTS

Laboratory confirmation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of the coronavirus disease 2019 (COVID-19) is crucial in the pandemic response. To date, detection of unique viral sequences (genetic material) using nucleic acid amplification tests (NAATs) primarily through Real-Time Reverse Transcription Polymerase Chain Reaction (rRT-PCR), is considered by the World Health continue reading : UNDERSTANDING SARS-COV-2 RT-PCR TEST RESULTS

GUIDELINES ON THE RECOGNITION OF TRAINING PROVIDERS FOR COVID19 RELATED TRAININGS (RT-PCR TESTING, BIOSAFETY/ BIOSECURITY, FIT
TESTING, OPS AND NPS SAMPLE COLLECTION)

RATIONALEIn accordance with Department Memorandum No. 2020-0538, the Research Institute for Tropical Medicine (RITM) is authorized to designate and certify training providers capacitating licensed COVID-19 testing laboratories, including training for new techniques such as pooled testing, and providing the requisite training for laboratories securing license-to-operate as COVID-19 testing laboratories. SCOPEThis guideline shall apply to all continue reading : GUIDELINES ON THE RECOGNITION OF TRAINING PROVIDERS FOR COVID19 RELATED TRAININGS (RT-PCR TESTING, BIOSAFETY/ BIOSECURITY, FIT
TESTING, OPS AND NPS SAMPLE COLLECTION)

GUIDELINES FOR THE RITM NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME (RITM-NEQAS)

RATIONALE As a DOH-designated National Reference Laboratory for infectious diseases (DO 2020-0820), RITM is mandated to provide EQA to laboratories in the country for bacteriology (including mycobacteriology), parasitology, transfusion-transmissible infections, and SARS-CoV-2. An External Quality Assessment Scheme (EQAS) evaluates the performance of participating laboratories by assessing the integrity of the entire testing process from sample continue reading : GUIDELINES FOR THE RITM NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME (RITM-NEQAS)

Biosafety Guidelines for laboratories handling and testing respiratory specimen for laboratory diagnosis of COVID-19 using Rapid Antigen Detection Kit

Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) is a virus responsible for the 2019 Coronavirus disease (COVID-19). It is a disease-causing human pathogen. It is vital that laboratories performing SARS-CoV-2 diagnostic tests and related laboratory procedures, including point-of-care testing, adhere to the standard biosafety practices and procedures and comply to the national guidelines as part of laboratory continue reading : Biosafety Guidelines for laboratories handling and testing respiratory specimen for laboratory diagnosis of COVID-19 using Rapid Antigen Detection Kit

RITM BRMO COVID-19 Specimen Storage and Disposition Guidelines

COVID-19 Testing Laboratories must determine the disposition of specimen used for laboratory diagnosis of SARS-CoV-2. Disposition pertains to the destination of specimen and information including its storage, transfer, destruction, and disposal after the desired laboratory procedures and/or examination has been performed.