US IVD Bacterial Test Standard

Transcription

1 Instructions for Use US IVD Bacterial Test Standard Mass calibration standard containing a typical Escherichia coli DH5 alpha peptide and protein profile plus additional proteins. For quality control and validation of MALDI Biotyper CA Systems Language: US-en Revision C (July 2015)

2 1 Intended Use Product Description Inspection, Storage and Stability Inspection upon Receipt Storage on Arrival Accelerated and Shipping Stability Study of BTS Real-Time Stability Study of BTS Storage after Reconstitution and Aliquoting In-Use Stability Study of reconstituted US IVD BTS US IVD BTS Sample Preparation Procedure Preparation of US IVD BTS Aliquots Inoculation of US IVD BTS Sample on a US IVD 48 Spot Target Manufacturer Intended Use US IVD Bacterial Test Standard (BTS) is an in-vitro- diagnostic product used for quality control and validation of Bruker microflex LT/SH mass spectrometers when used for the identification of microorganisms isolated from human specimens. US IVD BTS must be used when processing test organisms for identification on the MALDI Biotyper CA System. Caution: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner. 2 Product Description US IVD BTS contains a manufactured extract of Escherichia coli DH5 alpha that demonstrates a characteristic peptide and protein profile mass spectrum when tested on the MALDI Biotyper CA System. US IVD BTS is spiked with two additional proteins that extend the upper boundary of the mass range of US IVD BTS. The overall mass range covered by US IVD BTS is 3.6 to 17 kda. Each tube contains enough material for the inoculation of approximately 40 US IVD 48 Spot Target positions. US IVD BTS is an in-vitro diagnostic device designed to be used only with the Bruker MALDI Biotyper CA System. Page 2 of 8 US IVD Bacterial Test Standard Instructions for Use Revision C

3 3 Inspection, Storage and Stability 3.1 Inspection upon Receipt Check the US IVD BTS package upon receipt. If the tubes are damaged, do not use. 3.2 Storage on Arrival 18 C US IVD BTS is shipped at ambient temperature but must be stored at 18 C or below immediately on arrival. The expiry date on the package is valid for the enclosed US IVD BTS when stored at 18 C or below on arrival Accelerated and Shipping Stability Study of BTS During this study, the following three (3) lots of BTS material were used: Lot Number Manufacture Date Feb Feb Feb2012 Shipping was simulated by storing the reagents in a climate controlled chamber at 37±2 C for two (2) weeks while an accelerated stability study was conducted at the same temperature for one (1) week. All testing was conducted in duplicate. For each time interval tested (one (1), two (2) and three (3) weeks), BTS was removed from the climate chamber, allowed to acclimate to room temperature and reconstituted in accordance with the instructions for use. Two targets were then inoculated with the BTS solution on 16 target plate positions and three (3) cross-joint positions [BTS_0, BTS_1 and BTS_4]. Testing then proceeded in accordance with the instructions for use. Revision C US IVD Bacterial Test Standard Instructions for Use Page 3 of 8

4 Results All lots met all performance specifications and testing demonstrated marginal standard deviations. Table: Accelerated/Shipping Stability Results Test Condition Lot# , Lot# , Lot# , Lot# , Lot# , Lot# , No Aging ± ± ± ± ± ± week ± ± ± ± ± ± weeks ± ± ± ± ± ± weeks ± ± ± ± ± ± Real-Time Stability Study of BTS During this study, the following three (3) lots of BTS material were used: Lot Number Manufacture Date Jul Jun Jun2011 All three (3) lots of material were maintained at recommended storage conditions of 18 C. At designated time intervals [3, 6, 9, and 12 months], BTS was removed from the freezer, reconstituted, and tested utilizing the same testing process as described in the accelerated/shipping stability study Results Long-term stability testing is ongoing; however, data received to date confirms product stability for up to 12 months. Table: Real-Time Stability Results Test Condition Lot# , Lot# , Lot# , Lot# , Lot# , Lot# , No Aging ± ± ± ± ± ± months ± ± ± ± ± ± months ± ± ± ± ± ± months ± ± ± ± ± ± months ± ± ± ± ± ± Page 4 of 8 US IVD Bacterial Test Standard Instructions for Use Revision C

5 3.3 Storage after Reconstitution and Aliquoting US IVD BTS must be reconstituted before use. We strongly recommend that reconstituted US IVD BTS is aliquoted and frozen using 0.5 ml screw cap micro tubes with screw caps. 18 C Frozen, reconstituted US IVD BTS can be stored for up to 5 months at 18 C or below In-Use Stability Study of reconstituted US IVD BTS Testing for in-use (reconstituted) stability was done using four vials of a single lot of BTS reagent [ , manufacture date: 27 Sep 2011]. Four BTS vials were reconstituted in accordance with the instructions for use and two pools, each containing the contents of two vials, were created. Tests were carried out on eight (8) target plate positions and one (1) cross-joint position immediately after reconstitution in accordance with the instructions for use. The pooled BTS solutions were then placed into the freezer and tested at the following time intervals: 1, 2, 3, 4, 5 and 6 months. At each time point, both (pooled) BTS vials were brought to room temperature and tested as described above Results Reconstituted BTS was tested over a six (6) month period and testing confirmed sample stability at 18 C or below after five (5) freeze-thaw cycles. Because there was one BTS target spot at the six (6) month time point that yielded a <2.2, reconstituted stability is limited to five (5) months. Table: In-Use (Reconstituted) Stability Results Aging # of MBT ID, < 2.2 # of MBT ID, < 2.2 No Aging ± / ± /8 1 month ± / ± /8 2 months ± / ± /8 3 months ± / ± /8 4 months ± / ± /8 5 months ± / ± /8 Revision C US IVD Bacterial Test Standard Instructions for Use Page 5 of 8

6 4 US IVD BTS Sample Preparation Procedure Note Poor sample preparation will impact product performance and will result in low resolution and poor reproducibility. The generation of ions through MALDI depends on the presence of an optimal ratio of matrix substance to analyte. For best results, use all materials as directed and use only chemicals recommended for use by Bruker (for example, CHROMASOLV LC-MS solvents). Chemicals and Materials Required Standard solvent (acetonitrile 50%, water 47.5% and trifluoroacetic acid 2.5%) from Sigma- Aldrich, which has been tested by Bruker and is recommended for reconstituting US IVD BTS. US IVD 48 Spot Target (# ). US IVD HCCA portioned (# ) Equipment and Tools Required but not Provided Centrifuge, pipettes, pipette tips Screw cap micro tubes (Sarstedt, # ) with screw caps (Sarstedt, # ). Page 6 of 8 US IVD Bacterial Test Standard Instructions for Use Revision C

7 4.1 Preparation of US IVD BTS Aliquots 1. Add 50 µl of standard solvent to the US IVD BTS pellet and dissolve by pipetting up and down at least 20 times at room temperature. Avoid foaming of the solution! 2. Incubate the US IVD BTS solution for 5 minutes at room temperature and then mix by pipetting up and down at least 20 times. 3. Centrifuge at 13,000 rpm for 2 minutes at room temperature. 4. Pipette 5 µl aliquots of the supernatant into screw cap micro tubes and close tubes tightly. 5. Store the aliquots at 18 C or below. 4.2 Inoculation of US IVD BTS Sample on a US IVD 48 Spot Target Note Frozen US IVD BTS aliquots should be thawed at room temperature and mixed by flicking the screw cap micro tube with a finger. Screw cap micro tubes should be closed and stored at 18 C or below immediately after preparation of US IVD BTS sample spots. Each 5 µl aliquot contains enough material for at least four sample spots. US IVD BTS must be inoculated onto each US IVD 48 Spot Target before processing. 1. Select two positions on a US IVD 48 Spot Target (cross-joint positions are recommended). Pipette 1 µl of US IVD BTS solution onto each position. 2. Allow the US IVD BTS sample spots to dry at room temperature. 3. After drying, overlay each US IVD BTS sample spot with 1 µl US IVD HCCA portioned solution. Note After the sample has dried, US IVD HCCA portioned must be added within 30 minutes. If US IVD HCCA portioned matrix solution is not applied within 30 minutes after the sample has dried, the MALDI target plate must be cleaned and the inoculation of US IVD BTS must be repeated. 4. Allow the US IVD BTS sample spots to dry at room temperature. Note: If US IVD BTS does not meet all required performance specifications, the test run will be invalid. If US IVD BTS is not inoculated onto a target before processing, the test run will be invalid. Revision C US IVD Bacterial Test Standard Instructions for Use Page 7 of 8

8 5 Manufacturer Bruker Daltonics Inc 40 Manning Road, Manning Park Billerica, MA USA Support Phone: +1 (877) access code 724 Fax: +1 (978) Internet: Sales Information Phone: +1 (978) Web: Hours: Monday - Friday: 5 am - 12 midnight EST Weekends/Holidays: 9 am - 9 pm EST For consumables orders, PO questions and Service Contract quotes, please call +1 (877) during business hours. Ordering Information Product Part Number US IVD Bacterial Test Standard # # Descriptions and specifications supersede all previous information and are subject to change without notice. Copyright 2015 Bruker Daltonics Inc. Page 8 of 8 US IVD Bacterial Test Standard Instructions for Use Revision C