Screening |
Points |
These screenings are used for patients suspected of having leukemia at the initial examination
(at which a high-level expression is seen) to detect leukemia-related chimeric genes.
If chimeric mRNA is detected, the level of the chimeric mRNA is reported as “number of copies/μg RNA.”
For monitoring of treatment, put in a request for each of quantitative and qualitative assays
of the detected chimeric gene at the time of screening.
In the assays, in-house prepared reagents are used. |
Performance |
The lower limit of quantification (or the lowest reportable value) is 50 copies/μg RNA. |
Parameters screened |
- 0M857 8
M857 4
Screening of chimeric genes related to leukemia, quantitative
The following 14 parameters are included:
Major BCR-ABL1, minor BCR-ABL1, PML-RARA, RUNX1-RUNX1T1, CBFB-MYH11, DEK-NUP214, NUP98-HOXA9,
ETV6-RUNX1, TCF3-PBX1, STIL-TAL1, KMT2A-AFF1, KMT2A-AFDN, KMT2A-MLLT3, KMT2A-MLLT1
|
Quantitative assays, Real-time PCR |
Points |
These assays are used for monitoring of treatment.
Results are reported as “corrected value of chimeric mRNA (number of copies/μg RNA),”
“measured value of chimeric mRNA (number of copies/μg RNA),”
and “measured value of GAPDH (internal standard) (number of copies/μg RNA).”
Reporting results below the lower limit of quantification
■ < 50 copies/μg RNA
■ None-detected (below the detection limit of the assay)
Even if a result is reported as “None-detected (below the detection limit of the assay),”
it does not rule out the possibility of existence of various chimeric genes. Diagnosis shall be
made comprehensively, taking into account other test results and clinical findings.
In the assays, in-house prepared reagents are used. |
Performance |
The lower limit of quantification (or the lowest reportable value) is 50 copies/μg RNA. |
Parameters screened |
-
- 02646 2
2646 1 Major BCR-ABL1 mRNA, quantitative
- 02984 7
2984 0 minor BCR-ABL1 mRNA, quantitative
- 02946 9
2946 2 TCF3-PBX1 mRNA, quantitative
- 02989 2
2989 6 PML-RARA mRNA, quantitative
- 02988 3
2988 9 CBFB-MYH11 mRNA, quantitative
- 02991 9
2991 3 RUNX1-RUNX1T1 mRNA, quantitative
- 02993 7
2993 8 ETV6-RUNX1 mRNA, quantitative
-
- 02944 1
2944 8 KMT2A-AFF1 mRNA, quantitative
- 06835 8
6835 3 KMT2A-AFDN mRNA, quantitative
- 02945 0
2945 5 KMT2A-MLLT3 mRNA, quantitative
- 06832 1
6832 1 KMT2A-MLLT1 mRNA, quantitative
- 02994 6
2994 5 NUP98-HOXA9 mRNA, quantitative
- 06830 3
6830 7 STIL-TAL1 mRNA, quantitative
- 02992 8
2992 1 DEK-NUP214 mRNA, quantitative
|
Qualitative assays, Nested PCR |
Points |
These assays are used for monitoring of treatment and relapse with high sensitivity to detect
various chimeric mRNAs.
Results are reported as “The chimeric mRNA was none-detected” or “Detected.”
* Qualitative assays also have the detection limit; therefore, a result of “None-detected” does
not completely rule out the possibility of minimal residual disease (MRD).
In the assays, in-house prepared reagents are used. |
Performance |
The lower limit of detection is 10 copies/μg RNA. |
Parameters
screened |
-
- 06324 5
6324 2 Major BCR-ABL1 mRNA, qualitative
- 06325 4
6325 0 minor BCR-ABL1 mRNA, qualitative
- 00B92 8
0B92 8 micro BCR-ABL1 mRNA, qualitative
- 02498 7
2498 6 TCF3-PBX1 mRNA, qualitative
- 06321 8
6321 1 PML-RARA mRNA, qualitative
- 02734 4
2734 5 CBFB-MYH11 mRNA, qualitative
- 06010 3
6010 7 RUNX1-RUNX1T1 mRNA, qualitative
- 06016 7
6016 1 RUNX1-MECOM mRNA, qualitative
-
- 02307 8
2307 6 ETV6-RUNX1 mRNA, qualitative
- 02293 4
2293 2 KMT2A-AFF1 mRNA, qualitative
- 0M498 7
M498 9 KMT2A-AFDN mRNA, qualitative
- 02294 3
2294 0 KMT2A-MLLT3 mRNA, qualitative
- 02295 2
2295 7 KMT2A-MLLT1 mRNA, qualitative
- 06039 2
6039 3 DEK-NUP214 mRNA, qualitative
|