ViveST Dry Validation Kit PRODUCT INSERT

Transcription

1 ViveST Dry Validation Kit PRODUCT INSERT Part No. V-ST-DVK-27-E Summary and Explanation The ViveST DRY VALIDATION KIT contains all the components necessary for mock sample loading and the validation of drying time for your specific geographical location and environmental condition. (See Figure 1). Figure 1: ViveST Dry Validation Kit Components Warnings and Precautions For Research Use Only. Not for In Vitro Diagnostic Use. 1

2 Materials Provided ViveST Dry Validation Kit contains: Component Quantity Description Storage Experimental Tubes 18 Pre- labeled Tubes Indicating 6 Different Drying Validation Times Positive Controls 3 Pre- labeled Positive Controls Negative Controls 3 Pre- labeled Negative Controls Standards 3 Pre- labeled Standards Tubes Indicating Improperly, Partial and Completely Dried ViveST Matrices Rehydration Buffer 2 15mL Bottles of Rehydration Buffer Dry Validation Kit Procedure 1. Remove all ViveST Dry Validation Kit components from their respective packaging. 2. The ViveST Experimental tubes are pre- labeled. There are three (3) ViveST tubes for each time point to be tested. The time points provided in this kit are spaced in one hour drying time increments representing 4, 5, 6, 7 and 8 hours and a single set of three units for the overnight time point. 3. Remove the three (3) Negative and three (3) Positive CONTROL pre- labeled ViveST tubes from the packaging. 4. Organize the pre- labeled ViveST EXPERIMENTAL and CONTROL drying validation tubes in triplicate columns using their respective drying time or CONTROL designation on a clean, level work surface, biological hood, or biological cabinet. NOTE: Start with the Positive Control set followed by the Negative Control set followed by the Experimental tubes in respective order starting with the 4- hour time point. 2

3 5. Un- cap each of the ViveST EXPERIMENTAL and CONTROL tubes leaving the ViveST caps plus matrix standing upright and erect in front of the respective labeled tube body set. (See Figure 2 below). 6. Turn the ViveST tubes upside down within the Laminar Flow Hood or biological cabinet to prevent environmental moisture from entering the desiccant color indicator capsule during validation procedure. Figure 2: Uncapped Rows of Positive Control (PC), Negative Control (NC) and Experimental tubes in Sequential Order 7. Remove the two (2) room temperature vials of Base Matrix or Normal Human Plasma (NHP) supplied in the ViveST Dry Validation Kit. 8. Document the time you are starting the validation procedure. Slowly add 1 ml of BASE MATRIX to the ViveST Dry Validation cap containing absorbent ViveST Matrix for the NEGATIVE CONTROL and EXPERIMENTAL time points. DO NOT add BASE MATRIX to the POSITIVE CONTROLS Tubes. 9. After completing the loading of BASE MATRIX to each ViveST matrix immediately re- cap the three (3) NEGATIVE CONTROL ViveST Dry Validation tubes and place to the side. NOTE: Leave the circulating airflow device, biological hood or biological cabinet running at ALL times during this validation experiment. In order for ViveST to dry properly a steady airflow is required over the matrix to facilitate wicking and evaporation. 10. For each EXPERIMENTAL time point (incremental 4-8 hours and overnight) load 1 ml of Base Matrix. Re- cap each set of three (3) respective pre- labeled ViveST Dry Validation tubes for each sequential time point as reached. Re- cap the tubes tightly and place to the side. NOTE: Leave the three (3) POSITIVE CONTROL tubes in the circulating airflow device, biological hood or biological cabinet running overnight along with the three (3) EXPERIMENTAL OVERNIGHT specimen time points. 3

4 11. The following morning re- cap the POSITIVE CONTROL and EXPERIMENTAL OVERNIGHT tubes tightly. Note the time of capping in order to calculate the drying time for the OVERNIGHT samples. 12. Place ALL EXPERMENTAL and CONTROL specimens in an incubator at medium heat (30 C to 37 C) or alternatively in a warm dark area. DO NOT incubate the ViveST drying validation tubes in a naked flame or a heat source greater than 47 C. 13. Allow the EXPERIMENTAL and CONTROL specimens to incubate for 72 to 96 hours in medium heat (30 C to 37 C). 14. If an incubator is not available a dark warm area can be used, however, the incubation period may need to be extended. Results and Interpretation 1. Compare the POSITIVE and NEGATIVE CONTROL tubes to the color STANDARDS tubes. The POSITIVE CONTROL should be DARK BLUE in color while the NEGATIVE CONTROL will be bright PINK (See Figure 3). Figure 3: Positive, Negative and Standard Control Color Comparison 2. Compare each EXPERIMENTAL time point to the color STANDARDS tubes. In order to define the clear cutoff for required ViveST Matrix drying time ALL three tubes of a respective time point must be completely DARK BLUE in color. NOTE: For optimal assay testing results choose the next greater incremental time point by adding 1 hour of drying time to the clear cutoff time point described as 4

5 EXPERIMENTAL tubes containing three DEEP BLUE color indicating desiccant capsules for a given SINGLE time point. 3. The ViveST color key (Figure 4) provided below can be used to determine an approximate volume of liquid retained in the absorbent ViveST Matrix for the EXPERIMENTAL timed drying increments. Figure 4: ViveST Dry Validation Kit Color Key PINK = Incomplete or Insufficient Dry Time PINK- BLUE or LIGHT BLUE = Partial drying or insufficient drying DARK BLUE = COMPLETE drying sufficient for stable transportation CONTACT INFORMATION ViveBio, LLC 5185 Peachtree Parkway Suite 380 Norcross, GA USA phone: (877) web: For Technical Support: support@vivebio.com To Purchase ViveBio, LLC Products: purchasing@vivebio.com ViveBio and ViveST are registered trademarks of ViveBio, LLC All Rights Reserved No general patent(s) or license of any kind is granted other than this specific use from purchase of ViveST device. Part Number V-ST-DVK-27-E 5