Product Overview
The essential control substance is a weakly positive non fixed value quality control substance, with a target value of 1.5-4 times the detection limit of the detection kit (500 copies/mL). Perform preliminary characterization of the harvested pseudovirus culture medium, dilute it to the required concentration, and then use digital PCR for molecular counting to determine the value.
The new generation of respiratory and intestinal pathogen nucleic acid detection quality control products based on VSV RNA virus vectors developed are the first domestic and foreign technology products, achieving international leading levels in product design, product performance, and product quality. They overcome the major problem of the current nucleic acid testing field that cannot fully monitor the entire process from RNA nucleic acid extraction to reverse transcription reaction to PCR amplification, avoiding false negatives, and making the testing results more accurate and reliable.
Field of use
Research and development of nucleic acid testing kit
Indoor quality control of nucleic acid testing kits
Precision testing for laboratories
Monitoring instrument status, personnel operation, and effectiveness of reagent kits and sampling tubes
Applicable scenarios
LDT performance confirmation: precision, accuracy, specificity, stability, detection limit
Verification of the performance of the reagent kit
Performance evaluation between test kits
Daily quality control
Product Features
² More stable: Pseudovirus particle structure is stable, nuclease tolerance, and long-term storage at -20 degrees Celsius
² More reliable: no detection of target sequence DNA residues, ensuring the accuracy of detection results
² More comprehensive: capable of monitoring the entire process of RNA nucleic acid extraction, reverse transcription, and amplification
² Traceability: Digital PCR molecular counting method traceable to SI international units of moles
² Safer: non replicable, non pathogenic, and no risk of gene insertion
² More universal: compatible with mainstream fluorescent PCR detection kits and nucleic acid extraction kits
² Easy and fast operation: liquid state, no need for re dissolution, no need for dilution, ready to use, avoiding pollution, good repeatability in and between tubes
Organism/Virus |
Strain |
RP2.1 Control 1 |
RP2.1 Control 2 |
Adenovirus Type 1 |
N/A |
Positive/ 阳性 |
Negative / 阴性 |
Adenovirus Type 3 |
N/A |
Positive/ 阳性 |
Negative / 阴性 |
Adenovirus Type 31 |
N/A |
Positive/ 阳性 |
Negative / 阴性 |
C. pneumoniae |
CWL-029 |
Positive/ 阳性 |
Negative / 阴性 |
Influenza A 2009 H1N1pdm |
A/NY/02/2009 1 |
Positive/ 阳性 |
Negative / 阴性 |
Influenza A H3N2 |
A/Brisbane/10/07 |
Positive/ 阳性 |
Negative / 阴性 |
Metapneumovirus 8 |
Peru6-2003 2 |
Positive/ 阳性 |
Negative / 阴性 |
M. pneumoniae |
M129 |
Positive/ 阳性 |
Negative / 阴性 |
Parainfluenza Type 1 |
N/A |
Positive/ 阳性 |
Negative / 阴性 |
Parainfluenza Type 4 |
N/A |
Positive/ 阳性 |
Negative / 阴性 |
Rhinovirus 1A |
N/A |
Positive/ 阳性 |
Negative / 阴性 |
SARS-CoV-2 |
USA-WA1/2020 3 |
Positive/ 阳性 |
Negative / 阴性 |
B. parapertussis |
A747 |
Negative/ 阴性 |
Positive / 阳性 |
B. pertussis |
A639 |
Negative/ 阴性 |
Positive / 阳性 |
Coronavirus 229E |
N/A |
Negative/ 阴性 |
Positive / 阳性 |
Coronavirus HKU-1 |
Recombinant 4 |
Negative/ 阴性 |
Positive / 阳性 |
Coronavirus NL63 |
N/A |
Negative/ 阴性 |
Positive / 阳性 |
Coronavirus OC43 |
N/A |
Negative/ 阴性 |
Positive / 阳性 |
Influenza AH1 |
A/New Caledonia/20/99 |
Negative/ 阴性 |
Positive / 阳性 |
Influenza B |
B/Florida/02/06 |
Negative/ 阴性 |
Positive / 阳性 |
Parainfluenza Type 2 |
N/A |
Negative/ 阴性 |
Positive / 阳性 |
Parainfluenza Type 3 |
N/A |
Negative/ 阴性 |
Positive / 阳性 |
RSV A |
N/A |
Negative/ 阴性 |
Positive / 阳性 |
盘内容 |
Strain |
Adenovirus 1 |
N/A |
Adenovirus 3 |
N/A |
Adenovirus 31 |
N/A |
B. parapertussis |
A747 |
B. pertussis |
A639 |
C. pneumoniae |
CWL-029 |
Coronavirus 229E |
N/A |
Coronavirus HKU-1 |
Recombinant1 |
Coronavirus NL63 |
N/A |
Coronavirus OC43 |
N/A |
Influenza A H1N1pdm |
A/NY/02/092 |
Influenza AH1 |
A/New Caledonia/20/99 |
Influenza AH3 |
A/Brisbane/10/07 |
Influenza B |
B/Florida/02/06 |
M. pneumoniae |
M129 |
Metapneumovirus 8 |
Peru6-20033 |
Parainfluenza 1 |
N/A |
Parainfluenza 2 |
N/A |
Parainfluenza 3 |
N/A |
Parainfluenza 4 |
N/A |
Rhinovirus 1A |
N/A |
RSV A |
N/A |
SARS-CoV-2 |
USA-WA1/20204 |
Negative Control |
N/A |