Instruction for FibroTx TAP KIT handling

Instruction for FibroTx TAP KIT handling 1 Storage and identification of FibroTx TAP KITs ............................................................. 2 1.1 FibroTx TAP KIT description ........................................................................................................................ 2 1.2 Storage of FibroTx TAP KITs ......................................................................................................................... 3 1.3 Sending back FibroTx TAP KITs for biomarker analysis .................................................................. 3 1.4 Identifying of FibroTx TAPs .......................................................................................................................... 3 2 Using FibroTx TAPs for biomarker measurement from skin .................................... 5 1 1 Storage and identification of FibroTx TAP KITs 1.1 FibroTx TAP KIT description FibroTx KITs will be supplied in transport boxes. Each transport box contains up to 10 KITs for biomarker measurements from skin of patients or healthy volunteers. Each FibroTx KIT contains up to 8 TAPs (Transdermal Analysis Patch) according to the costumers request. Figure 1: FibroTx TAP KIT transport box, FibroTx TAP KIT and FibroTx TAPs. One FibroTx TAP KIT composes of following components (see Figure 2): 1. Up to 8 FibroTx TAPs Each TAP in KIT is marked with a number: 1, 2, 3 and/or 4 identifying the combination of capture antibodies on TAP. 2. 2-‐3 ampules containing physiological saline solution for TAP activation 3. FibroTx TAP KIT package insert 4. FibroTx TAP Kit shell Figure 2: Components of FibroTx TAP KIT. 2 1.2 Storage of FibroTx TAP KITs 1. BEFORE USE: after arrival the transport boxes containing FibroTx KITs MUST be stored at 40C. Expiration of FibroTx TAP KITs is ONE MONTH from date of receipt, stored at 40C. 2. AFTER USE: after biomarker measurement, store FibroTx TAP KITs at 4°C until shipment. Notice: after applying the kits must be sent back to FibroTx during one week. 1.3 Returning FibroTx TAP KITs for biomarker analysis 1. Depending on the quantity of KITs to send to FibroTx for biomarker analysis, select the transport package: • In case of returning 1-‐2 FibroTx KIT, use the smaller envelope • In case of returning 3-‐5 FibroTx KIT, use the larger envelope • In case of returning 6-‐10 FibroTx KITs, use the transport box (the same in which the KITs arrived) 2. Receiver contacts (FibroTx LLC) and contacts are marked on the transport package. Contact with courier and send the package out. 3. Notify the recipient (FibroTx LLC: [email protected]) for estimated delivery date immediately. 1.4 Identifying of FibroTx TAPs Each biomarker measurement will have a unique code that composes of following components: 1. Unique FibroTx TAP KIT identification code marked on KIT insert in Step 3: Figure 2: Identification code on FibroTx TAP KIT insert (in Step 3). 3 2. TAP number printed on TAP adhesive, which identifies the biomarker combination. If only one combination is used, the number could be excluded. Figure 3: Identification number printed on left side of the TAP adhesive. 3. The position letter of the TAP. Position letter of TAP is printed on Step 4 of KIT insert where the TAP is applied (after removal from skin) in order to return to FibroTx for analysis. Figure 4: Position letter of TAP is printed on Step 4 on FibroTx TAP KIT insert. 4. Altogether, combination of three foregoing codes creates a unique identification code for each TAP. This code will be linked with TAP biomarker data readout and send to client. 4 2 Using FibroTx TAPs for biomarker measurement from skin 1. Wear gloves for TAP handling. 2. Take the FibroTx TAP KIT out of the transport box prior the application process. 3. Open the KIT and remove the TAP from the package inserts. Do not discard the package insert and the package shell! 4. Apply TAP to skin as follows: 4.1. Carefully remove the protection layer from the back of the TAP. Do not touch the capture antibody microarray! 4.2. Do not stretch the adhesive material – the capture antibody microarray can tear 4.3. Apply TAP to skin and make sure that TAP is properly fixed on skin 5. Repeat step 3-‐4 for all TAPs planned to apply to skin. 6. Wet the TAP using solution from the ampule provided with KIT as follows: 6.1. Remove the ampule from the KIT package 6.2. Open the ampule 6.3. Hold the ampule 1cm high from the TAP 6.4. Apply 4 drops of the solution from the ampule into the opening on the top of TAP (see Figure 6) 6.5. Repeat step 6.3-‐6.4 for all TAPs applied to skin Figure 6: Activation of TAP. 7. TAP MUST be kept on skin for exactly 20 minutes. 8. Write down the specific identification code from FibroTx TAP KIT insert in Step 3. 9. Write down the TAP identification codes according to 1.4 of the instruction. 10. Remove the TAP carefully from the skin as follows: 10.1.
Remove the TAP from skin gently; do not stretch the adhesive material – the capture antibody microarray can tear; 10.2.
Apply removed FibroTx TAP back into the KIT package insert: make sure that the middle part of the TAP (the round capture antibody microarray) is placed over the round hollow opening in TAP KIT package insert (see Fig 7). Don’t press on the middle part of the TAP! 5 Figure 7: Applying FibroTx TAPs back onto the FibroTx TAP KIT package insert 11. Confirm with signature and date (on KIT Step 3) that all procedures have been performed according to the instruction. 12. Assemble the KIT: fold the TAP KIT package insert together and insert it into the package shell. 2. FibroTx TAP
package shell
1. Folded
FibroTx TAP
package insert 3. Fully assembled
FibroTx TAP KIT, store
4C until shipping
Figure 8: Placing FibroTx TAP package insert into the FibroTx TAP package shell 6

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