Rapid Detection FAQs

Transcription

1 Rapid Detection FAQs 3M Rapid Detection Reader What are the dimensions of the Rapid Detection Reader? The Rapid Detection Reader includes the Control Module and the Test Module. The Control Module is 185 mm x 195 mm x 96 mm (D x W x H). The Test Module is 177 mm x 195 mm x 105 mm (D x W x H). Can the Rapid Detection Reader be interfaced with a laboratory information system (LIS)? Connectivity is available through Telcor Quick Suite. Contact 3M technical service at if your facility is interested in developing a site-specific interface. What is the purpose of the lot card? The lot card provides the Rapid Detection Reader with lot specific information used to determine if the target analyte is present in the patient sample. The information provided by the lot card includes the analyte being detected, the test kit calibration details and the test kit expiration. When the prepared test cartridge is inserted into the Rapid Detection Reader, a bar code on the bottom of the cartridge is scanned by the Rapid Detection Reader and the lot card information becomes available and is used to determine the test result. What is the RAMP ratio? The RAMP ratio corrects for test-to-test variations. The Rapid Detection Reader measures fluorescence emitted by complexes captured at the detection zone and the internal standard zone, and calculates a ratio between these measurements. Without the ratio, fluorescence at the detection zone would be measured alone, leading to extremely variable results. Can I visually read/interpret the test results if my Rapid Detection Reader is not working? No. The Rapid Detection Reader is required to interpret the test result. What are the features provided by the Rapid Detection Reader? Data management of the test record Objective test result determination no reliance on visual interpretation Programmable QC Auto-IQC (Internal Quality Control) LQC with optional lock-out Operator lock-out with variable access Rejects expired test cartridges Self-timed test - The test is automatically interpreted and the result is stored in the Reader database. Can I use my own USB flash drive rather than the one provided with the Rapid Detection Reader? The USB flash drive provided with the Rapid Detection Reader is configured to ensure the drive folders match the data files. To correctly configure an operator provided flash drive, contact Technical Service at for assistance.

2 What is IQC? IQC is the Rapid Detection Reader s internal self-test to ensure the system is operating within specifications. When IQC is initiated, the appropriate tests are performed on each port in each attached Test Module. IQC verifies the power supply voltage, system memory, cartridge transport system, LED function and incubator function for heated assays. During IQC the system also determines system power, verifies the system clock and verifies the Rapid Detection Reader calibration. How do you set the Rapid Detection Reader date and time? Refer to the 3M Rapid Detection Reader Operator Manual. Contact Technical Service at if further assistance is required. 3M Rapid Detection Flu A+B Test How many tests are in each test kit? Each test kit contains components to perform 25 tests. What are the test kit storage requirements? The Rapid Detection Flu A+B Test kit should be stored at 15-30ºC. Do not freeze. What is the test kit shelf life? 18 months Is the test CLIA waived? No. This test has the CLIA categorization of moderate complexity. What is the CMS suggested CPT code? Influenza A/B: What specimen types are acceptable? Nasal wash/aspirate, nasopharyngeal aspirate, nasopharyngeal (NP) swab What are the recommended nasopharyngeal (NP) swabs? Use sterile foam, polyester, nylon or rayon swabs. Calcium alginate swabs are not recommended. Does the test kit include collection swabs? No, the specimen collection material is NOT provided. Does the sample need to be tested immediately? For best results specimens should be tested as soon as possible. If samples are not tested immediately, they should be stored at 2-8ºC. Specimens may be held up to 72 hours at 2-8ºC prior to testing. After mixing the sample with the sample buffer and assay tip, can I wait before transferring the sample to the test cartridge? After mixing the sample with the assay tip, the sample MUST be immediately added to the test cartridge and the cartridge inserted into the Reader.

3 What is the time to result? The hands on sample preparation takes less than 3 minutes. The prepared test cartridge inserted into the Reader to test result is approximately 15 minutes. Can a bloody sample be tested? No interference was noted for samples containing blood up to 2% of the total sample volume. Refer to the package insert for potential interfering substances evaluated. How often should I perform QC? The reactivity of each new lot and of each new shipment of 3M Rapid Detection Flu A+B Test kit should be verified on receipt using positive and negative control swabs. Additional control testing may be required in accordance with applicable local, state and/or federal guidelines or accreditation requirements and each facility s standard quality control procedures. My patient result is positive for both influenza A and influenza B. Is that possible? Co-infection with influenza A and B is rare. Influenza A and B dual positive (influenza A and influenza B positive) clinical specimens should be re-tested. Repeatable dual positive results should be confirmed by cell culture before reporting. Does the Rapid Detection Flu A+B Test detect the 2009 H1N1 Influenza A virus? Although the 3M Rapid Detection Flu A+B Test has been shown to detect the 2009 H1N1 Flu virus in cultured isolates, the performance characteristics of this device with clinical specimens that are positive have not been established. The Rapid Detection Flu A+B Test detects the nucleoprotein antigen present in influenza A and B viruses. The Rapid Detection Flu A+B Test can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes. What proficiency testing materials are available? 3M recommends proficiency test samples from the American Proficiency Institute (API) and the College of American Pathologists (CAP). Details of program codes are available from 3M. 3M Rapid Detection RSV Test How many tests are in each test kit? Each test kit contains components to perform 25 tests. What are the test kit storage requirements? The Rapid Detection RSV Test kit should be stored at 15-30ºC. Do not freeze. What is the test kit shelf life? 18 months Is the test CLIA waived? No. This test has the CLIA categorization of moderate complexity. What is the CMS suggested CPT code? RSV: 87420

4 Can this test be used on pediatric patients? The Rapid Detection RSV Test aids in the rapid diagnosis of RSV infections in symptomatic patients 21 years of age and younger. What sample types are acceptable? Nasal wash/aspirate, nasopharyngeal aspirate, nasopharyngeal (NP) swab What are the recommended nasopharyngeal (NP) swabs? Use sterile foam, polyester, nylon or rayon swabs. Calcium alginate swabs are not recommended. Does the test kit include collection swabs? No, the specimen collection material is NOT provided. Does the sample need to be tested immediately? For best results specimens should be tested as soon as possible. If samples are not tested within 4 hours, they should be stored at 2-8ºC. Specimens may be held up to 72 hours at 2-8ºC prior to testing. After mixing the sample with the sample buffer and assay tip, can I wait before transferring the sample to the test cartridge? After mixing the sample with the Assay Tip, the sample MUST be immediately added to the Test Cartridge and the cartridge inserted into the Reader. What is the time to result? The hands on sample preparation takes less than 3 minutes. The prepared test cartridge inserted into the Reader to test result is approximately 15 minutes. Can a bloody sample be tested? No interference was noted for samples containing blood up to 2% of the total sample volume. Refer to the package insert for potential interfering substances evaluated. How often should I perform QC? The reactivity of each new lot and of each new shipment of 3M Rapid Detection RSV Test kit should be verified on receipt using Positive and Negative Control Swabs. Additional control testing may be required in accordance with applicable local, state and/or federal guidelines or accreditation requirements and each facility s standard Quality Control procedures. My test specimen is viscous and when tested an error message is displayed. What steps can be taken? If a Sample Error 2, Low Signal or High Background error message is displayed and the sample is viscous (mucoid), add an equal volume transport media to the remaining sample, mix by inversion and repeat the test on the diluted sample. NOTE: Diluting the sample may lower the overall test sensitivity. Other Questions Who can I contact for technical questions? Please submit your technical question on our Contact Us page.

5 Who can I contact to purchase product? Who do I contact to order an additional Test Module? Who do I contact to order additional control swabs? Who do I contact to order additional printer labels? Who do I contact to order a replacement ribbon for my printer? Who do I contact to order a replacement transfer device? Who do I contact to order a replacement USB flash drive? Who do I contact to order a replacement Reader Configuration Utility (RCU)?