Patient Preparation
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- Quantiferon-TB Gold Plus Blood Collection 4 Tube Set (gray, green, yellow and purple).
- Prior to collection, store Quantiferon-TB Gold Plus blood collection tubes at 4 - 25°C.
- QFT-Plus Blood Collection Tubes should be at room temperature 17 - 25°C at the time of blood collection.
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Specimen Collection |
- Refer to QuantiFERON-TB Gold Plus Package Insert for collection instructions.
- For each patient, collect blood by venipuncture directly into each of the QFT-Plus Blood collection tubes. If a butterfly needle is being used to collect blood, a purge tube should be used prior to QFT blood collection tubes being used.
- Blood volume for each tube must be within black marks on side of tubes (0.8 to 1.2 mL).
- Gently invert the tubes 10 times. Overly vigorous shaking may result in gel disruption and could lead to aberrant results
- Following labeling, filling and inverting tubes must be incubated 37°C ± 1°C within sixteen (16) hours of collection. If unable to incubate at the collection facility, the sample must be shipped to the laboratory on the day of collection.
- Maintain tubes at 17 - 25°C until incubation. Gently invert tubes 10 times to remix immediately prior to incubation.
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Specimen Processing |
- Incubate the tubes at 37°C ± 1°C for 16 - 24 hours. Keep tubes upright during incubation.
- Tubes must be incubated prior to centrifugation.
- Centrifuge tubes for 15 minutes at 2000 - 3000 RCF (g). The gel plug will separate the cells from the plasma. If no separation occurs, re-centrifuge tubes.
- Maintain tubes at 2 - 8°C after centrifugation until shipped.
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Specimen Labeling |
- Specimen must be labeled with at least two unique patient identifiers and match accompanying QFT Log Sheet.
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Specimen Storage and Preservation
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- If incubation cannot be done immediately after collection, maintain tubes at 17 - 25°C until incubation. Then gently invert tubes 10 times prior to incubation at 37°C ± 1°C.
- After incubation of the blood collection tubes at 37 ±1°C, tubes may be held between 4 - 27°C for up to 3 days prior to centrifugation.
- Centrifuged specimens can be held at 2 - 8°C for up to 28 days.
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Specimen Transportation |
- If tubes have been centrifuged, ship specimen set at 2 - 8°C.
- Ship non-incubated specimen sets at 4 - 27°C on the day of collection.
- Keep specimen set together. Each 4-tube specimen set must be placed in an individual biohazard bag with absorbent material.
- All infectious substance shipments must conform to U.S. Department of Transportation (DOT) Hazardous Materials Regulations (HMR 49 C.F.R. Parts 171-180).
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Specimen Acceptability and Rejection |
- Centrifuged specimens must be received at laboratory within 28 days of centrifugation.
- Non-incubated specimens must be received at laboratory within sixteen (16) hours of collection.
- Unsatisfactory specimens include, but may not be limited to
- Overfilled (more than 1.2 mL) or underfilled (less than 0.8 mL) tubes
- Specimens not maintained at 17 - 25°C prior to incubation
- Specimens not incubated within sixteen (16) hours of collection
- Specimens not centrifuged within three (3) days of incubation
- Specimens stored longer than 28 days at 2 - 8°C after centrifugation
- Specimens that are incorrectly labeled
- Expired tubes
- Specimens incubated less than 16 hours or more than 24 hours
- Specimens incubated at greater than 37 ± 1°C.
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Testing Location |
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