Diagnostic PCR Testing Services, Nasal Swab, QuantiVirus SARS-CoV-2 Covid-19

Diagnostic PCR Testing Services, Nasal Swab, QuantiVirus SARS-CoV-2 Covid-19

Call for price Call (415) 747-2087 to order.

Part Number:
TESTING-SERVICE_DC
Lead Time:
2-3 weeks
Shipping:
Free Shipping on most orders*

Description

Large-Scale COVID-19 - PCR Testing Available

Employee Testing for Businesses Preparing to Re-open Amid COVID-19 Pandemic

 

CP Lab Safety is offering COVID-19 testing using traditional PCR (nasopharyngeal swab) tests. This test is currently used by hospitals to diagnose current infection with COVID-19. Our team can arrange for a medical professional to come to your facility and perform testing for up to 1,000 individuals at a time. Multi-day testing is also available if needed.

This is an FDA approved, validated PCR test, performed by a CLIA laboratory.

Results: Results will be delivered in just 3-5 days. Individuals that test positive for this test will be directed to their doctor for further assessment and treatment.

As patients exposure status will change over time, we recommend performing this test at least once a month.

For inquiries please call 415-747-2087. Quotations and lead times will be provided upon request.

 


DiaCarta's new COVID-19 test kit is a high throughput test kit that is based on real-time Reverse-Transcription Polymerase Chain Reaction (RT-PCR) technology and is used for highly specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from saliva in addition to nasopharyngeal swabs, oropharyngeal, and sputum samples. The sensitivity reaches 50 copies per mL of SARS-CoV-2 viral load with a 95% confidence. Clinical validation of the assay shows 95% sensitivity and 100% specificity, with no cross-reaction to different types of non-SARS-CoV-2 species.

Validated for saliva samples, the newly developed QuantiVirus™ SARS-CoV-2 Multiplex Test Kit overcomes the detection barrier caused by the global shortage of the swabs for OP and NP sampling. With four reactions combined into one reaction, the new kit has increased the throughput significantly (see the comparison of the two kits below for detailed assay difference).

Key Product Information

  • High throughput: 93 samples (96-well plate) or 381 samples (384-well plate) per run
  • Detects as low as 50 copies of viral RNA /mL sample, enables early virus detection and diagnosis
  • Minimal sample input: as low as 2 µL sample needed
  • Easy saliva sampling in addition to NP, OP, and sputum
  • < 2 hours from RNA to results

Features

  • High Sensitivity: Detects as low as 50 copies of viral RNA /mL sample, enables early virus detection and diagnosis
  • High Throughput: Up to 93 clinical samples can be tested on one 96-well plate; up to 381 clinical samples can be tested on one 384-well plate
  • High Specificity: Proven by in silico analysis as well as wet lab testing Intended Sample Types: Easy sampling with saliva in addition to NP, OP, and sputum, overcoming short supply of swabs
  • Minimal Sample Input: As low as 2 µL sample needed
  • Ease of Use: Only one reaction mix needs to be set up per sample
  • Fast Turnaround Time: Only 2 hours from nucleic acid extraction to results
  • Flexibility: Assay validated on widely used qPCR instruments including ABI 7500 Fast Dx, ABI QuantStudio 5 and BioRad CFX 384
  • Precision: Coefficient of variation (CV) < 3%, allowing reproducible test results

Specifications

  • Sample Type: Nasopharyngeal Swabs, Oropharyngeal Swabs, Sputum and Saliva
  • Pack Size:24 Reactions, 48 Reactions, or 480 Reactions
  • Turnaround Time: ~2 hours
  • Stability: Stable for 12 Months at -25°C to -15°C

Validated Machines

  • Thermo Fisher (ABI) QuantStudio 5
  • Thermo Fisher (ABI) 7500 Fast Dx
  • Bio-Rad CFX 384

Note: All orders are evaluated due to FDA guidelines. If we deem your order as not for professional use, your order will not be processed. We are required to abide by Federally enforced rules.

Assay Performance

The assay has a wide dynamic range as shown in the figure below: Amplification curve of 10 -fold serial dilution of templates showing the dynamic range. The assay performance summary for QuantiVirus™ SARS- CoV-2 Multiplex Test Kit

  • Intra-assay reproducibility: Coefficient of Variation (%): < 3%
  • Operator reproducibility: Coefficient of Variation (%): < 3%
  • Inter-instrument reproducibility: Coefficient of Variation (%): < 3%
  • Assay detection limit (LOD)50 copies per mL of SARS-CoV-2 viral with a 95% confidence


Clinical evaluation of the QuantiVirus™ SARS-CoV-2 Multiplex Test Kit was conducted with contrived sputum specimens including 80 positive and 30 negative samples. Sputum samples were mixed with the lysis buffer from the extraction kit at 1:1 ratio before spiking in non-infectious viral particles. Sputum samples (20 samples) were contrived with non-infectious viral particles templates at 1X LoD (1×50 copies/mL), 20 samples at 2xLoD (2×50 copies/mL), 20 samples at 4xLoD (4×50 copies/mL) and 10 sputum samples were spiked with non-infectious virus at 6xLoD (300 copies/mL) and another 10 sputum samples were spiked at the concentration of 10xLoD (500 copies/mL). Viral RNA was extracted from spiked samples and tested blindly with the QuantiVirus™ SARS-CoV-2 RT-qPCR. Data show that there is 95% agreement with the spiked sample at 1xLoD (1×50 copies/mL), and 100% agreement at all other concentrations including 100 copies/mL(2xLoD) 200 copies/mL (4xLoD), 300 copies/mL (6xLoD) and 500 copies/mL. For negative control, all the 30 samples were tested negative.

Table: Contrived clinical sample evaluation with viral particles (ABI 7500 Fast Dx).

Third-Party Clinical Test Results

The third-party clinical test results demonstrated that DiaCarta’s QuantiVirus™ SARS-CoV-2 Test Kit shared the same testing results (100% match), compared with peer products, even at much lower sample concentration in some cases.

Sample IDAbbott m2000CDC AssayDiaCarta's QuantiVirus™ Assay
A   Detected Detected at 1:100 dilutions
B   Detected Detected at 1:1000 dilutions
C Not Detected Not Detected Not Detected
D Not Detected Not Detected Not Detected
E Not Detected Not Detected Not Detected
F Not Detected Not Detected Not Detected
G Not Detected Not Detected Not Detected
H Not Detected Not Detected Not Detected
I Not Detected Not Detected Not Detected
J Detected Detected Detected
K Detected   Detected
L Detected   Detected
M Detected Detected Detected
N Not Detected Not Detected Not Detected

Resources

Instructions For Use - QuantiVirus™ SARS-CoV-2 Multiplex Test Kit

QuantiVirus™ SARS-CoV-2 Multiplex Test Kit Product Brochure

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