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PE5006

Supelco

SARS-CoV-2 Proficiency Testing Kit

Proficiency testing material

Synonym(s):
COVID proficiency testing kit, 2019-nCoV test kit

Quality Level

packaging

set of 5 ea

Featured Industry

Clinical
Diagnostic Assay Manufacturing

storage temp.

−20°C

General description

SARS-CoV-2 proficiency testing kit is designed for use in diagnostic and clinical testing laboratories to aid in the quality assurance of COVID 19 screening.
It is produced following ISO/IEC 17043:2010. The PT portfolio allows our test components to offer significant performance data to monitor and prove competency to customers, accreditation bodies or both.

Type of PT Scheme:
SARS-CoV-2 (SAR) Proficiency Testing

Matrix: Liquid DBS Buffer Solution

Analyte/s:
Values of analytes vary lot to lot.

All information regarding the use of the SARS-CoV-2 proficiency testing kit can be found in the reporting packet which will be available to download at PT Portal.

Application

COVID 19 Proficiency Testing Kit for use with PCR-based methods that detect the viral RNA by nucleic acid amplification.

Do you have any questions? Explore our FAQs.
For more information on this product, please contact our PT Service Team.

Features and Benefits

  • Samples produced in accordance with ISO 13485
  • Tubes of positive RNA sequence containing a range from >20 up to 100000 copies/sample
  • Tubes as negative control
  • Levels and positive or negative control assignments are unknown to customers
  • The wide concentration range of samples allows for the effective challenge of the instrument′s sensitivity across its dynamic range
  • Quick turn / on-demand study options for optimal scheduling convenience
  • Positive samples have the same sequence as JRC positive sample (EURM-019)
  • Noninfectious liquid specimen samples, targeting certain CDC and WHO consensus gene sequence regions such as RdRp, N (nucleocapsid), E (envelope) and/or S (spike)
  • Evaluation of qualitative results as well as quantitative properties such as Cq (Ct) values for semi-quantitative comparison

Preparation Note

Description
  • This “SARS-CoV-2 Proficiency Testing Kit” contains 5 samples “SARS-CoV-2 Sample A” through “E”. Each of these tubes contains relevant CDC and WHO consensus gene sequence regions for the PCR testing in a range from 0 to 500000 copies: RdRp, N (Nucleocapsid, CDC-N1, CDC-N2, CDC-N3, Thailand, Japan), E (Envelope) and S (Spike).
  • Levels and positive / negative assignments of the individual tubes are unknown.
  • A safety data sheet (SDS) is available online.
  • The samples are noninfectious liquid specimens.
  • Before beginning with the experiment, appropriate methods should be chosen and the procedure must be planned accordingly.
  • If solutions need to be transferred to other tubes, labeling with a permanent marker is recommended to avoid mix-up between solutions.
  • There is enough material of each sample to run experiments more than once to confirm the findings.

Preparation Instructions

  • Remove sample tubes from the refrigerator and allow them to equilibrate at room temperature for 15 min.
  • Apply the tube to a vortex mixer (or similar device) for approximately 5 sec to fully homogenize the solution.
  • Centrifuge the mixture for approximately 10 sec and use the volume specified in your RT and PCR testing method directly without further dilution.

Reporting Instructions
  • To receive qualitative and quantitative evaluations, analyze each tube by your normal testing procedure and report results for the individual samples as Cq / Ct values for the tested gene sequence(s) and as present ("1") or absent ("0") on the report form.
  • Analytes available to report for can be viewed after logging into supelco-pt.com.

Storage and Stability

Please refer to the sample label for the expiration date, specific storage temperature and specific storage conditions.

Other Notes

Are you new to Supelco Proficiency Testing? Be sure to register your account details in the PT Portal before placing your order.
This will provide access to data entry, reporting packets and final reports. Registrations will be approved shortly after your order is placed. For further questions, write to us at ptservice@milliporesigma.com.

When placing your order online, please indicate your study preference under the ‘your reference′ column. Available studies can be viewed at the bottom of the page.
Click here to learn more about Quick-Turn Studies (non-scheduled on-demand proficiency tests that are offered depending on lot availability). The Quick-Turn results are released within 48-72 hours whereas scheduled study reports are released within 21 days.

Final reports for qualitative data will be issued within 48 hours. Quantitative reports will be issued after enough data points have been received to evaluate against a study mean.

Proficiency Testing Schedule (2020-2021)

Analyte:
COVID Positive Presence/Absence

SARS-CoV-2 CDC and WHO consensus gene sequence
N1 Gene 0-500000 copies
N2 Gene 0-500000 copies
N3 Gene 0-500000 copies
N Gene-Thailand 0-500000 copies
N Gene-Japan 0-500000 copies
S Gene 0-500000 copies
E Gene 0-500000 copies
RdRP Gene 0-500000 copies

Kit Components Only

Product No.
Description

  • SARS-CoV-2 Sample A

  • SARS-CoV-2 Sample B

  • SARS-CoV-2 Sample C

  • SARS-CoV-2 Sample D

  • SARS-CoV-2 Sample E

Storage Class Code

10 - Combustible liquids

Certificate of Analysis

Certificate of Origin

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

Contact Technical Service