SmartSpot Quality currently provides one of the largest commercially available Xpert MTB/RIF EQA programs globally with instruments enrolled across 30 countries. SmartSpot has harnessed this platform in order to respond to the COVID-19 pandemic and provide a set of Quality Controls for molecular diagnostic SARS-CoV-2 assays.

SmartSpot’s QC products for SARS-CoV-2 are:

  • Stable at ambient temperatures for 12 months: This reduces the cost of shipping by 67% and mitigates the risk of damage to the controls when a cold chain is not maintained.
  • Non-infectious and packaged as dried spots on filter paper: this patented process enables the fastest global shipping turnaround times (typically 3-4 days) including customs clearance.

SmartSpot Quality’s Molecular SARS-CoV-2 Verification Program: SmartSpot offers a Molecular SARS-CoV-2 Verification Panel, which is designed to verify that both the instrument is working correctly and that the personnel running the instrument are adequately trained when using the new assay. The panel is intended to be used by laboratories as the first specimens tested prior to testing patient specimens.

The Verification program includes:

  • SmartSpot Panels:
  • 2 SARS-CoV-2 Positive Dried Culture Spots containing a safe, inherently non-infectious biomimetic control that contains the SARS-CoV-2 targets in the N, E and RdRP genes.
  • 2 SARS-CoV-2 Negative Dried Culture Spots containing a safe, inherently non-infectious biomimetic control that contains a target unrelated to SARS-CoV-2.

Note: Each Dried Culture Spot is eluted into 3ml of Saline or Viral Transport Medium at the time of use. This means each Verification panel yields either 32 or 16 controls, dependant on assay sample volume, namely:

  1. 300ul sample volume (e.g. Xpert Xpress SARS-CoV-2): A minimum of 16 positive and 16 negative controls
  2. 600ul sample volume (e.g. Roche Cobas SARS-CoV-2): A minimum of 8 positive and 8 negative controls
  • Site Support: This includes all support described below under Service Commitment.

SmartSpot Quality’s Molecular SARS-CoV-2 EQA Program consists of 3 EQA panels for 3 submissions per annum. Closing dates for submissions are: 30th of July, 30th of September and 30th of November.

The EQA Program includes the following:

  • SmartSpot Panels: 4 Dried Culture Spots (DCS), each containing either SARS-CoV-2 positive or SARS-CoV-2 negative material all of which is inherently non-infectious, inactivated, quantified and intact.

The SARS-CoV-2 positive DCS contain different combinations of the Targets in N, E and RdRP regions enabling robust testing within the EQA Program.

  • Site Support: This includes all support described below under Service Commitment.

SmartSpot Quality’s Weekly QC Program consists of one positive and one negative control to be tested at the beginning of each week. Each EQA panel contains four DCS and only one control per DCS is used for the EQA. As such, there is a remainder of 3 or 7 controls per DCS (depending on assay sample volume) which can be used in between EQA cycles to run weekly positive and negative controls. For assays using a sample volume of 300ul, there will be 14 positive and 14 negative controls available in between each EQA, yielding sufficient material to run weekly controls (14 runs available for 9 weeks in between each EQA cycle). (For assays requiring 600ul, only 6 runs will be available in between each EQA cycle, a shortfall of 3 runs in between each EQA and as such an extra 3 positive and 3 negative DCS (12 runs) will be supplied to enable weekly QC until the end of December 2020.

Service Commitment

SmartSpot strives to manufacture Quality Control products to the highest international standards. SmartSpot provides its customers with multiple levels of support in accordance with SmartSpots mission to assist diagnostic facilities globally in ensuring the accuracy of their patients’ test results. SmartSpots customer support includes:

  • Site Administration, Training and Support: This includes site enrolment, administration, technical support, training on result interpretation, troubleshooting and investigation report review as and when required.
  • Access to Automated Quality Assessment Tool: All participants are provided access to SmartSpot Monitor (SmartSpots web-based platform utilized by sites for submitting their Verification, EQA and Weekly QC results and reviewing their performance, see Annexure A and Annexure B for sample Verification reports).
  • Administrative Access to SmartSpotMonitor: Administrative access is provided to group administrators enabling managers and heads of programs to see the results of the sites that they are responsible for instantly. This enables immediate feedback to program managers providing an opportunity for real-time corrective action.
  • Group Management Reports: Customers with multiple sites receive a group program report following each panel submission. A teleconference is offered to the group managers with each report to discuss the report and its findings.
  • Group Data Analysis: Provide EQA data analysis to assist national programs in identifying / confirming trends in their patients’ results based on their EQA results.
  • Scientific Advisory Board: is available to make recommendations and assist with any relevant technical matters that may arise.

Shipping

SmartSpot is able to ship all Quality Control panels for 2020 in one shipment as the product is stable for 12 months at ambient temperatures. SmartSpot handles all shipping and customs clearance documentation. Despite logistics complications caused by the pandemic, SmartSpot is achieving shipping delivery times to international destinations of 5 – 8 days from order placement including customs clearance.

Bulk Orders

Economies of scale offer an opportunity for discounting and as such for bulk orders please contact dean@SmartSpotQ.com for more information.