Lyophilized IVD ANVISA Fluorescence PCR Detection Kit 40T/box

Product Description

REAGEN This kit is a full-component lyophilized fluorescent PCR reagent for patients with suspected cases of pneumonia, suspected aggregation cases of COVID-19 infection, and other patients who need to undergo clinical diagnosis of new coronavirus infection. The COVID-19 ORF1ab and N genes were specifically tested.

Detection Principle

REAGEN The COVID-19 nucleic acid detection kit is based on reverse transcription PCR combined with fluorescent probe amplification detection technology. Fluorescent labeling of specific fluorescent probes. 5'is labeled with a fluorescent reporter group and 3'is labeled with a fluorescent quencher group. Before amplification, the fluorescent signal of the reporter group is absorbed by the quencher group and cannot excite the fluorescent signal; during the PCR amplification process, Taq polymerase The 5'-3' exonuclease activity cuts off the fluorescent group of the probe, separates the fluorescent reporter group and the fluorescent quencher group, enables the fluorescence monitoring system to receive the fluorescence signal, and records the increase of the fluorescence level by the fluorescence PCR instrument .

Kit Contents, Storage and Shelf Life

REAGEN Table1:COVID-19 Real-Time Fluorescence PCR Detection Kit (lyophilized)

Note: Components to be prepared by the customer and not provided in this kit: RNA nucleic acid

extraction kit

The kit is stored at 25 ±5℃ before use, and the validity period is 12 months.

Suggestion: After adding ribozyme-free water to dissolve the RT-PCR Mix, the reaction solution should be divided into PCR reaction tubes according to a single portion of the reaction system and stored at -20℃ to avoid repeated freezing and thawing of the reagents and affecting the quality of the reagents.

Product Performance Index

a) Amplification efficiency and detection limit

The following results was obtained with Company Standard Materials, quantified with "COVID-19 RNAtranscribed in vitro Reference Material" from Shanghai Institute of Measurement and Testing Technology,NCRM Code: GBW(E) 091112, Certification Series No: H2003264, Batch Number: 200306, Certificate Date:202003. Period of validity: 202004.

Product 1 N gene detection limit is 18 copies/reaction, with R²=0.999 and amplification efficiency=97%.

b) Clinical Validation

Clinical validation was carried out at the PLA Central Division General Hospital in Wuhan, China withpreviously tested positive RNA samples using Sansure Biotech's COVID-19 diagnostic kit.

Comparison of Testing Results between REAGEN® Freeze-Dried Real-Time RT-PCR Detection Kit for COVID-19 and Sansure Biotech Novel Coronavirus (COVID-19) Nucleic Acid Diagnostic Kit in 39 Clinical Samples.

The results indicate that 87% (34/39) of the positive samples detected by Sansure Biotech's kits can bedetected with our product, and among the confirmed positive samples, there were more samples in thegrey range with Sansure Biotech's kit (20) than with ours (10). If fresh samples were used in a parallelexperiment, we anticipate that our product should have a similar or better performance and detectionrate.