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MSS Reference Standard Genomic DNA Cancer Test

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Microsatellite instability (MSI) refers to the phenomenon of changes in the length of the MS sequence caused by insertion or deletion mutations during DNA replication, which is often caused by defects in the mismatch repair (MMR) function. Correspondingly, if there is no insertion or deletion change in the repeating unit of a microsatellite in a tumor, the microsatellite is in a stable state, which is called microsatellite stability (MSS).
  • CBP80002-1/2/3/4

  • CBP80002-1/2/3/4

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Product Overview


The MSS Reference Standard Genomic DNA Cancer Test is a highly characterized genomic DNA (gDNA) reference material designed to validate microsatellite stability (MSS) detection assays in cancer diagnostics. Derived from well-characterized cell lines with confirmed microsatellite stable phenotypes, this standard provides a gold-standard control for verifying the performance of MSI/MSS classification workflows. With comprehensive validation across qPCR, fragment analysis, and NGS platforms, it enables clinical laboratories to ensure accurate identification of microsatellite stable tumors, which is critical for guiding immunotherapy decisions and prognostic assessments .


Product Features


Genomically Verified MSS Profile

The standard contains DNA from cell lines with intact mismatch repair (MMR) systems, exhibiting stable microsatellite loci across all 5 recommended markers (BAT25, BAT26, D5S346, D2S123, and D17S250). Each marker’s stability is verified by >1000x NGS coverage, ensuring confidence in assay validation .


Broad Concentration Range

Supplied at 30 ng/μL in Tris-EDTA buffer (pH 8.0), the gDNA is provided in convenient 1 μg aliquots, allowing flexible dilution to match clinical sample concentrations. This enables realistic simulation of various input amounts encountered in routine testing .


Multi-Platform Validation

Validated for compatibility with all major MSI detection methodologies, including:

• Multiplex qPCR-based fragment analysis

• Targeted NGS panels

• Immunohistochemistry (IHC) for MMR proteins

• Capillary electrophoresis systems


Usage


Assay Calibration

Use the standard to establish baseline MSS profiles for your detection platform. Run in triplicate alongside patient samples to verify that microsatellite loci exhibit consistent lengths within the expected range for stable alleles.


Method Validation

Incorporate the standard into method validation studies to:

• Determine assay specificity for MSS classification

• Establish run-to-run reproducibility

• Verify no cross-reactivity with MSI-H samples

• Calibrate interpretation thresholds for MSI calling


Storage and Preparation

Store at -20°C for long-term stability (36 months) or at 4°C for up to 6 months. Avoid repeated freeze-thaw cycles by aliquoting upon first use. Dilute to working concentration (typically 5-20 ng/μL) using molecular biology-grade water or TE buffer .


FAQ


What cell lines are used in this standard?

The standard is derived from characterized colon adenocarcinoma cell lines with confirmed MSS status and intact MMR protein expression (MLH1, MSH2, MSH6, and PMS2). Exact cell line information is provided in the certificate of analysis.

How does this standard support clinical trial testing?

By providing a consistent MSS reference, the standard ensures that MSI classification remains uniform across multi-site clinical trials, reducing inter-laboratory variability in patient stratification for immunotherapy eligibility .

Can it be used with NGS panels targeting microsatellites?

Yes, the standard is optimized for use with targeted NGS panels. Its high-quality gDNA generates consistent coverage across microsatellite loci, enabling accurate assessment of panel performance .

What is the difference between this standard and FFPE-based MSS controls?

While FFPE-based controls assess the entire workflow including fixation effects, this gDNA standard focuses specifically on the molecular detection phase, allowing laboratories to isolate and troubleshoot amplification and detection steps .


Cat.No.

ID

MSI Status

Format

Quantity

Buffer

Storage Conditions

Details

CBP80002-1

MSS-1

MSS

Genomic DNA

1ug+1ug

Tris-EDTA 2~8℃

MSS-P1 Reference Standard CBP80002-1.pdf

CBP80002-2

MSS-2

MSS

Genomic DNA

1ug+1ug

Tris-EDTA

2~8℃

MSS-P2 Reference Standard CBP80002-2.pdf

CBP80002-3

MSS-3

MSS

Genomic DNA

1ug+1ug

Tris-EDTA 2~8℃

MSS-P3 Reference Standard CBP80002-3.pdf

CBP80002-4

MSS-4

MSS

Genomic DNA

1ug+1ug

Tris-EDTA

2~8℃

MSS-P4 Reference Standard CBP80002-4.pdf


Method

Test content

Advantages

Disadvantages

IHC

Detects 4 known MMR proteins (MLH1, MSH2, MSH6, and PMS2)

Low price, simple and fast operation

1) It is possible to miss some abnormalities caused by other MMR proteins
2) Due to tumor heterogeneity, the scores of the entire tumor may be inconsistent

PCR

Detection of BAT25, BAT26, D2S123, D5S346 and D17S250 loci

1)The gold standard for testing
2)Objectively assess functional dMMR activity

1)High requirements for laboratory conditions
2)Relatively expensive

NGS

Capable of sequencing hundreds of thousands to millions of gene molecules at one time

1) High throughput, high sensitivity
2) Can detect unknown mutations

Subsequent data analysis is difficult



General information

Cat.No.

ID

MSI Status

Format

Quantity

Buffer

Storage Conditions

Details

CBP80002-1

MSS-1

MSS

Genomic DNA

1ug+1ug

Tris-EDTA 2~8℃

MSS-P1 Reference Standard CBP80002-1.pdf

CBP80002-2

MSS-2

MSS

Genomic DNA

1ug+1ug

Tris-EDTA

2~8℃

MSS-P2 Reference Standard CBP80002-2.pdf

CBP80002-3

MSS-3

MSS

Genomic DNA

1ug+1ug

Tris-EDTA 2~8℃

MSS-P3 Reference Standard CBP80002-3.pdf

CBP80002-4

MSS-4

MSS

Genomic DNA

1ug+1ug

Tris-EDTA

2~8℃

MSS-P4 Reference Standard CBP80002-4.pdf



Detection Methods

MSI is often caused by MMR gene mutation and functional loss. Therefore, when detecting MSI in cancer cells, we can determine whether MSI occurs by detecting MMR gene loss, such as protein level detection relying on immunohistochemistry technology, or directly detect sequence changes of MSI, such as molecular level detection such as PCR (polymerase chain reaction) detection.

Method

Test content

Advantages

Disadvantages

IHC

Detects 4 known MMR proteins (MLH1, MSH2, MSH6, and PMS2)

Low price, simple and fast operation

1) It is possible to miss some abnormalities caused by other MMR proteins
2) Due to tumor heterogeneity, the scores of the entire tumor may be inconsistent

PCR

Detection of BAT25, BAT26, D2S123, D5S346 and D17S250 loci

1)The gold standard for testing
2)Objectively assess functional dMMR activity

1)High requirements for laboratory conditions
2)Relatively expensive

NGS

Capable of sequencing hundreds of thousands to millions of gene molecules at one time

1) High throughput, high sensitivity
2) Can detect unknown mutations

Subsequent data analysis is difficult



Product Application

1.Quality control products for corresponding molecular detection experiments

2.Optimize and verify new experimental processes or kits

3.Detection of the sensitivity, accuracy and specificity of experimental methods

4.Compare the detection differences of various platforms


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