Storage and Stability. Actalyke ACT test tubes can be stored at room temperature (15-30°C). They must not be used past the expiration date that appears on the barcode label affixed to each test tube and its corresponding box. INSTRUMENTS The Actalyke test tubes should be used with the Actalyke MINI II, Actalyke XL or Hemochron® instruments. Refer to the appropriate Operator’s Manual’s for detailed instructions. SPECIMEN COLLECTION AND HANDLING C-ACT and K-ACT: The specimen collection and test procedure for both the C-ACT and K-ACT test tubes are exactly the same. Use a 5.0 cc syringe to obtain the blood specimen as follows: Extracorporeal line: Using a two-syringe technique, flush the extracorporeal blood access line by withdrawing 5.0 cc of blood into a syringe and discarding it. Then use a second syringe to obtain a 3.0 cc sample for testing. In-dwelling line: Discontinue fluids drip, if necessary. Using a two-syringe technique, withdraw 5.0 cc of blood into a syringe and discard it. Then use a second syringe to obtain a 3.0 cc sample for testing. Venipuncture: Using a two-syringe technique, withdraw 2.0 cc of blood into a syringe and discard it. Then use a second syringe to obtain a 3.0 cc sample for testing.
Storage and Stability. MAX-ACT test tubes can be stored at room temperature (15-30°C). They must not be used past the marked expiration date.
Storage and Stability. 5. The sealed pouches in the test kit and the kit components should be able to be stored between 4°C to 40°C (room temperature) till the duration of the shelf life as indicated.
Storage and Stability. When stored at 2-8°C, the PBS is stable until the expiration date indicated on the package. The diluted PBS is stable for 1 year stored at 2-8°C. Signs of Deterioration: Discard if it shows signs of microbial or cross-contamination.
Storage and Stability. The stain may be stored as packaged or in a tightly closed staining dish at 15-30°C. The unopened stain is stable until the expiration date on the bottle. Signs of Deterioration: The stain should be a homogeneous mixture free of precipitate. Do not use if excessive evaporation occurs or if large amounts of precipitate occur. Electra® HR Buffer (Cat. No. 5805)
Storage and Stability. The prepared Clear Aid should be stored in a tightly closed container at 15 to 30°C to prevent evaporation of the methanol. When evaporation occurs, the plates may delaminate. Water contamination, from over-use of the clearing solution, will cause the plate to be cloudy. The Clear Aid is stable until the expiration date on the bottle label. Signs of Deterioration: Clear Aid should be a clear, colorless liquid, although it may appear cloudy when cold. Do not use the material upon evidence of gross contamination or discoloration. Discard the prepared Clear Aid solution if the plates appear cloudy after the clearing procedure. PermaClear Solution (Cat. No. 4950)-Optional Ingredients: N-methyl pyrrolidinone and PEG. WARNING: FOR IN-VITRO DIAGNOSTIC USE - IRRITANT DO NOT PIPETTE BY MOUTH. VAPOR HARMFUL. In case of contact, flush affected areas with copious amounts of water. Get immediate attention for eyes.
Storage and Stability. The Contractor shall: Provide temperature controlled storage at the Contractor site approved by HHS, according to cGMP and the Contractor’s product specifications. Store bulk lots and final containers physically segregated from other products Ensure proper labeling of stored materials as USG property. Execute stability testing of stored material in a manner consistent with the stability testing plan approved by HHS. Report interim data and results to HHS on a monthly basis. Ensure sufficient representative samples are available at the time of ‘Storage and Stability’ task order award for stability testing for 120 months from the date of manufacture. Ensure stored materials are compliant with the Contractor’s internal quality control system and are ready for use in further cGMP governed manufacturing of clinical material or licensed doses as directed by HHS. Provide the government access to review the security system in place and request updates as needed. Include in monthly report inventory (lot number, number of lots, number of vials), including inventory quantity changes, current quantity, storage facility/location, manufacturing date, latest stability result for potency, date of next expected stability result and the current expiration date (if applicable). Ensure that material being relocated for the contractors’ convenience is adequately insured at no cost to the government and with CO approval. Conduct testing necessary to ensure continued use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed doses. Make appropriate updates to the regulatory documentation supporting the continued use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed doses. If using a subcontracted storage site, provide the quality agreement, specify the location and terms of the storage contract and receive approval by HHS. Submit standard data reports ‘MN014’ and ‘MN017’ according to instructions in ‘Reporting Requirements’. Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.
Storage and Stability. Plasma as well as whole blood should always be stored at room temperature (15-30°(C). Cover samples to maintain the pH. Tests should be performed within three hours after sample collection. PROCEDURE Materials Provided: Ristocetin Cat. No. 5199 Materials Required but not provided in the kit: Platelet Aggregometer (AggRAM Analyzer or PACKS-4 Analyzer recommended) Plastic pipette tips Plastic or siliconized test tubes Pipettes to deliver 50 µL or 25 µL Pipettes to deliver 450 µL or 225 µL STEP BY STEP METHOD NOTE: The AggRAM and the PACKS-4 can be run with the recommended (standard) volumes or with one-half (micro) vol-umes.Standard volume tests are done at 1000 rpm and micro volume tests are done at 600 rpm. Patient results should be compared to normal ranges run under the same conditions. The following steps are for standard volume; for micro volume use one half of the standard volumes.
Storage and Stability. The Chromogen should be stored at 2 to 8°C and is stable until the expiration date indicated on the vial. Signs of Deterioration: The product should be discarded if it shows noticeable signs of turbidity.
Storage and Stability. MAX-ACT test tubes can be stored at room temperature (15-30°C). They must not be used past the marked expiration date. INSTRUMENTS The MAX-ACT test tubes should be used with the Actalyke, Actalyke Mini, Actalyke XL or Hemochron® instruments. Refer to the appropriate Operator’s Manual for detailed instructions.
