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A+CheQ COVID-19 RT-qPCR Kit

Expected use

The A + CheQ COVID-19 High-Speed ​​RT-qPCR Detection Kit is an in vitro kit Diagnosis (IVD) Real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test for the qualitative detection of SARS-CoV-2 viral nucleic acids in human superior clinical specimens (such as nasopharyngeal and oropharyngeal specimens swab) that are suspected of COVID-19 by your healthcare provider. The proof is limited to US laboratories certified under Clinical Laboratory Improvement 1988 Amendments (CLIA), 42 U.S.C. §263a, to perform highly complex tests.

The results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory samples during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine the infectious status of the patient. Positive results do not rule out bacterial infection or co-infection with other viruses.

The agent detected may not be the definitive cause of disease Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. Negative results do not exclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological data information.

Test principle

A + CheQ COVID-19 High-Speed ​​RT-qPCR Detection Kit is Real-Time Based Reverse transcriptase-polymerase chain reaction (RT-qPCR) technology, primer and A probe. The High-Speed ​​RT-qPCR + CheQ COVID-19 Detection Kit is designed specifically to detect ORF1ab and N genes of the SARS-CoV-2 genome on top respiratory samples from patients with suspected COVID-19. This kit is designed as a multiplex RT-qPCR for the detection of SARS-CoV-2 ORF1ab (FAM), N gene (HEX), and human RNase P housekeeping gene (for control, Cy5) simultaneously in one tube.

Components and Storage

The A + CheQ COVID-19 High-Speed ​​RT-qPCR Detection Kit should be stored at -24 ℃ ~ -18 ℃ until the expiration date. Do not use expired reagents from the kit. Do not repeat the freeze/thaw procedure more than 3 times after opening. Exposure to light, heat or moisture should be avoided due to the stability of this kit. Yes, the team or components have been damaged during transportation, do not use them. Keep the reagents are separated from the sample material to avoid contamination.

Warning and Caution

  • The A + CheQ COVID-19 High-Speed ​​RT-qPCR Detection Kit has not been authorized or approved by the FDA or authorized by the EUA. The validation of this test has not been reviewed by the FDA. Review under the USA program is pending.
  • For in vitro diagnostic (IVD) and prescription use only.
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
  • Handle all specimens as if infectious using safe laboratory procedures. Refer CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens associated with SARS-CoV-2
  • Positive results are indicative of the presence of SARS-CoV-2 RNA.
  • Before testing, all components should be thawed, mixed and spin
  • Do not use it after the expiration date is printed on the kit box.
  • Keep all materials on ice when in use.
  • Read the instructions for use carefully before performing the test.
  • All instruments used in the experiment must be sterilized to avoid pollution.
  • Do not mix reagents from different lots.
  • Dispose of all materials in a safe and acceptable manner, in accordance with all Legal Requirements.
  • Do not use if the package or any of the assay components are damaged.
  • Keep extracted RNA on a cold block or on the ice during the reaction setup.
  • Avoid possible contamination of reagents with extracted nucleic acids, PCR products and positive control.
  • To avoid contamination of reagents, the use of filter tips is recommended.
  • Do not eat, drink or smoke in the area where the samples and the kit are located. The contents are manipulated.

Collection, transport and storage of samples

Sample collection devices are not provided with this kit. To use this kit, the upper part respiratory sample (nasopharyngeal (PN) and oropharyngeal (OP) swab) that collected by a healthcare provider is prepared prior to testing. Specimen collection, storage, and handling should follow CDC guidelines.

  • Sample collection

Use only synthetic fibre swabs with plastic handles. Do not use calcium alginate swabs or swabs with a wooden handle as they may contain substances that inactivate some viruses and inhibit PCR tests. Immediately place swabs in sterile tubes containing media of viral transport.

  • Storage

Store samples at 2-8 ° C for up to 72 hours after collection. If a delay in test or shipment is awaited, store samples at -70 ° C or below.

  • And sent

For national and international shipments, specimens must be packed, shipped and transported in accordance with the current edition of International Dangerous Goods Regulations of the Air Transport Association (IATA) External icon. Follow the shipping regulations for Biological Substances UN 3373, Category B when the shipment of possible SARS-CoV-2 samples.