MammaTyper

Report Generator

For in-vitro diagnostic use

Pathologist: Department: Date of measurement: Plate ID: MammaTyper® Lot:

Instructions:
Step 1, Export the data
1) Export data from FAM and HEX channels separately;
2) For LightCycler480 II/cobas480/Versant kPCR AD module, save the data as .txt file; for CFX96/MX3000P, save as .xlsx file; for AriaDx, save as .xls; for SLAN-96P, first export the data as .xlsx, then open the file and 'save as' .xls file; for ABI7500 Fast, first save the data as .csv file, then open the file and 'save as' .xlsx file.
Step 2, Format the data
1) The sample name should not contain slash '/' .
2) For Negative Control (NC), when no signal was detected, manually adjust the Cq to 40 (identified by missing values in LightCycler480/cobas480/CFX96 instrument, 'NoCt' in SLAN-96P, and 'NoCq' in AriaDx);
3) For samples, if no signal was detected from all 3 measurements, set the Cq to 40. However, if one or two measurements are missing, the results of the sample are not valid, repeat the experiment again;
4) Make sure the sample names are consistent among all the wells within the same row. Failure to follow the naming rule may result in errors during the calculation;
5) Regardless how many samples (1-8) were run on the plate, make sure you export the data for the whole plate except for position D10-D12 and E10-E12. Any missing wells on the file will result in errors during the calculation.
Step 3, Upload the data
Select both files for FAM and HEX channels and upload them together to the software.

	Negative (40-ΔΔCq)	Low Positive (40-ΔΔCq)	High Positive (40-ΔΔCq)
ERBB2	< 40.40	≥ 40.40
ESR1	< 36.90	36.90-38.00	≥ 38.00
PGR	< 35.10	35.10-36.50	≥ 36.50
MKI67	< 35.90	≥ 35.90

	Negative (40-ΔΔCq)	Low Positive (40-ΔΔCq)	High Positive (40-ΔΔCq)
ERBB2	< 40.00	≥ 40.00
ESR1	< 36.70	36.70-37.70	≥ 37.70
PGR	< 35.20	35.20-36.60	≥ 36.60
MKI67	< 35.80	≥ 35.80

	Negative (40-ΔΔCq)	Low Positive (40-ΔΔCq)	High Positive (40-ΔΔCq)
ERBB2	< 40.40	≥ 40.40
ESR1	< 37.10	37.10-38.20	≥ 38.20
PGR	< 35.00	35.00-36.30	≥ 36.30
MKI67	< 36.30	≥ 36.30

	Negative (40-ΔΔCq)	Low Positive (40-ΔΔCq)	High Positive (40-ΔΔCq)
ERBB2	< 40.40	≥ 40.40
ESR1	< 37.50	37.50-38.50	≥ 38.50
PGR	< 34.90	34.90-36.20	≥ 36.20
MKI67	< 35.90	≥ 35.90

	Negative (40-ΔΔCq)	Low Positive (40-ΔΔCq)	High Positive (40-ΔΔCq)
ERBB2	< 40.40	≥ 40.40
ESR1	< 36.90	36.90-38.00	≥ 38.00
PGR	< 34.80	34.80-36.20	≥ 36.20
MKI67	< 35.50	≥ 35.50

	Negative (40-ΔΔCq)	Low Positive (40-ΔΔCq)	High Positive (40-ΔΔCq)
ERBB2	< 40.30	≥ 40.30
ESR1	< 36.70	36.70-37.90	≥ 37.90
PGR	< 34.80	34.80-36.40	≥ 36.40
MKI67	< 35.00	≥ 35.00

	Negative (40-ΔΔCq)	Low Positive (40-ΔΔCq)	High Positive (40-ΔΔCq)
ERBB2	< 40.20	≥ 40.20
ESR1	< 36.80	36.80-37.90	≥ 37.90
PGR	< 34.90	34.90-36.30	≥ 36.30
MKI67	< 34.90	≥ 34.90

	Negative (40-ΔΔCq)	Low Positive (40-ΔΔCq)	High Positive (40-ΔΔCq)
ERBB2	< 40.60	≥ 40.60
ESR1	< 37.10	37.10-38.40	≥ 38.40
PGR	< 35.00	35.00-36.50	≥ 36.50
MKI67	< 35.70	≥ 35.70