Anchor SARS-COV-2 Reference Panel (Trisomy Cell Free gDNA)

 

Trisomy Cell Free gDNA

Anchor SARS-COV-2 Reference Panel

Part Number: 60230002
4 Vials of positives and 1 vial of negative
(0, 1000, 10,000, 100,000 and 1,000,000 copies/ml,
Negative has 10,000 copy/ml human gDNA),
1 mL Fill Volume, -20°C Storage

Anchor SARS-COV-2 Reference Standard
Part Number: 60230003
1 Vials (500,000 copies/ml)
1 mL Fill Volume, -20°C Storage

Trisomy Cell Free gDNA

Anchor SARS-COV-2 Negative
Part Number: 60230004
1 Vials (10,000 copy/ml human gDNA)
1 mL Fill Volume, -20°C Storage

Product Insert Reference Panel
Product Insert Reference Standard
Safety Data Sheet

LIMITATIONS:
For Research Use Only. Not for use in diagnostic procedures.

INTENDED USE:
The Anchor SARS-COV-2 Reference Panels are intended for use by clinical labs and assay manufacturers to establish a quantitative molecular-based assay for SARS-COV-2 and to validate the assay’s performance.

PRODUCT DESCRIPTION:
The Anchor SARS-COV-2 Reference Standard and Panel are made from a non-pathogenic recombinant RNA virus. The virus carries known target sequences (Wuhan-Hu-1, NC_045512.2) used in more than 160 molecular tests worldwide, including the coding regions for ORF1ab, RDRP, S, E, N, M, ORF8 and unique regions among the coronavirus family. The target titers for panel members are 1,000, 10,000, 100,000 and 1,000,000 copies/ml. The target titer for Reference Standard is 500,000 copy/ml. For the exact value of a specific lot, please refer to the Certificate of Analysis (CoA). Trisomy Cell Free gDNA

Trisomy Cell Free gDNA

cfDNA Extraction Sensitivity Controls (Trisomy Cell Free gDNA)

 

Trisomy Cell Free gDNA)

Does your cfDNA extraction process affect the Limit of Detection (LOD) of a particular gene target? Our new products, cfDNA Extraction Sensitivity Panels and Extraction Low Positive Controls, can help your research and development for liquid biopsy assays.

(Trisomy Cell Free gDNA)

NEW PRODUCTS: cfDNA EXTRACTION SENSITIVITY PANELS &  CONTROLS

The Extraction Sensitivity Controls can help by monitoring plasma cfDNA loss, determining how low the absolute plasma cfDNA number of copies can be reliably extracted, and standardizing QC workflow for plasma cfDNA extraction process.

Two extraction sensitivity panels and two extraction low positive controls are currently available as catalog products. Also, the customized panels and controls can be built per requirements of customer. For the price and availability of catalog and customized products, please send an email inquiry to info@anchormolecular.com.

Extraction Sensitivity Panel 1 (for absolute copies/ml)

• DNA-free plasma spiked with a 170bp specific DNA fragment at 0, 12, 25, 50, 100, 200 copies/ml in a constant 5 ng/ml fragmented gDNA background. Assay for this specific fragment is separately sold.

Extraction Sensitivity Panel 2 (for gDNA pg/ml)

• DNA-free plasma spiked with ~170bp gDNA fragments at 0, 30, 100, 300, 1,000, 3,000 pg/ml. Assay for a house keeping gene is separately sold.

Extraction Low Positive Controls

• DNA-free plasma spiked with ~170bp specific fragments or gDNA at a fixed low concentration.

(Trisomy Cell Free gDNA)

(Trisomy Cell Free gDNA)

Application Example for qPCR (Cat. No. 60100040)

Native or synthetic ctDNA fragment can be spiked in a series of concentration in a constant gDNA background. The extraction sensitivity of a synthetic DNA fragment was compared between two cfDNA extraction kits via qPCR. A left graph shows the difference in the ability of extraction at 0 – 200 copies/ml range by the two kits. A right graph compares the %CV of 6 replicates per level.

 

DNA-Depleted Plasma (Trisomy Cell Free gDNA)

 

Trisomy Cell Free gDNA)

Build your own controls using your high-positive samples to save time. With our DNA-depleted human plasma (DNA-free plasma) as a matrix, you can produce reference materials specific to your time-sensitive needs while retaining the natural components of the sample.

 (Trisomy Cell Free gDNA)

Prefer to have a knowledgeable lab do the work? Send your plasma to Anchor Molecular and we’ll remove the DNA background for you.

Product Name	Cat. No.	Size
DD Plasma (DNA-Depleted Plasma)	60601001	50, 200, 500, 1000 ml
DD Serum (DNA-Depleted Serum)	60601002	50, 200, 500, 1000 ml

Why Is Plasma Better Than Buffer As Reference Material Matrix?

A plasma matrix is a better representation of a real patient sample because the natural, interfering proteins are retained. This allows for a more realistic process in your quality system.

 (Trisomy Cell Free gDNA)

Equal amounts of DNA fragments were spiked into TE Buffer (blue) and human plasma (red).

While the 170 bp peak was recovered similarly in each matrix, much more genomic DNA was extracted from the plasma than from the TE buffer resulting in a more patient-like matrix.
See Figure A.

 

Exosome counts in DNA-depleted plasma are normal compared to regular plasma.

 (Trisomy Cell Free gDNA)

 

AM DNA-Depleted Plasma

• Highest quality DNA-depleted human plasma
• For use in research, assay development, & daily assays
• Retains naturally-occurring, interfering proteins
• Allows for more realistic process in quality systems
• Customized plasma available upon request
• Price upon request

 (Trisomy Cell Free gDNA)

CHEMICAL PRODUCT CHARACTERISTICS

Concentration of DNA:  < 10 pg/mL

Total protein: 5-7 g/dL

Immunoglobulin G: 500-1700 mg/dL

Immunoglobulin A: 90-400 mg/dL

Immunoglobulin M: 20-172 mg/dL

Cholesterol, Total:  50-199 mg/dL

Triglycerides: 50-149 mg/dL

HDL Cholesterol:  > 20 mg/dL

VLDL Cholesterol: 10-40 mg/dL

LDL Cholesterol:  20-99 mg/dL

pH: 7.2-7.6

Tested Negative for HIV, HBV, HCV,

HTLV and Syphilis by FDA approved methods

cfDNA Extraction Specificity Controls (Trisomy Cell Free gDNA)

 

Trisomy Cell Free gDNA)

The Plasma Genomic cfDNA Extraction Control is for the purpose of monitoring the degree of genomic DNA (gDNA) contamination in the extracted cfDNA. DNA-free plasma is spiked with either with high molecular weight gDNA molecules or 170 bp cfDNA fragments or both.

(Trisomy Cell Free gDNA)

Why Extraction Control?

The extraction of cfDNA from patient plasma is a complicated process that causes significant variability from run to run, kit to kit, and operator to operator. Contaminated large-sized genomic DNA interferes with the mutation quantification of cfDNA, which is mainly ~170 bp in size.

(Trisomy Cell Free gDNA)

Some extraction kits are better in preferentially extracting the 170bp. Figure 4 shows the cfDNA extraction Kit #1 is much better in eliminating the gDNA contamination while maintaining superior extraction yield in 170 bp DNA fragments.

 

AM cfDNA Extraction Specificity Controls

• Screens high molecular weight and DNA fragment loss
• Four types of specificity controls:
  • Positive Control Plasma 1 – High MW gDNA +170bp fragments
  • Positive Control Plasma 2 – High MW gDNA only
  • Positive Control Plasma 3 – 170bp fragments only
  • Negative Control Plasma
• Price upon request

Product Name	Cat. No.	DNA in 5ml plasma
Positive Control Plasma 1: high MW gDNA + 170 bp fragments	60100001	10ng gDNA, 5ng 170bp
Positive Control Plasma 2:  high MW gDNA	60100002	10ng gDNA
Positive Control Plasma 3:  170 bp fragments	60100003	5ng 170bp
Negative Control Plasma	60601012	0ng

(Trisomy Cell Free gDNA)