Test Details
Methodology
Real-time polymerase chain reaction (PCR)
Result Turnaround Time
3 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
Detection and quantitation of BK Virus (BKV) in urine stabilized in cobas® PCR Media can be used as an aid in the diagnosis and management of BK virus infections. The assay is traceable to the 1st WHO International Standard for BK Virus Nucleic Acid Amplification Techniques (NAT)-based assays.
Special Instructions
Urine samples must be transferred to the cobas® PCR Urine Sample Kit within 24 hours of collection.
Limitations
The linear range of the assay is 200-100,000,000 IU/mL. The analytical sensitivity is 12.2 IU/mL.
Specimen Requirements
Specimen
Urine, stabilized in cobas® PCR Media
Volume
Fill urine to fall within the 2 black lines on the cobas® PCR Media tube.
Minimum Volume
Fill urine to fall within the 2 black lines on the cobas® PCR Media tube.
Container
cobas® PCR Media
Collection Instructions
Collect a urine sample in a sterile cup. Transfer the urine using the transfer pipette included in the cobas® PCR Urine Sample Kit to the cobas® PCR Media tube. Transfer enough urine so the level falls between the two black lines on the cobas® PCR Media tube. Cap the tube tightly and invert 5 times to mix the sample.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 90 days (stabilized in cobas® PCR Media) |
Refrigerated | 90 days (stabilized in cobas® PCR Media) |
Frozen | Unstable |
Storage Instructions
Submit specimen in cobas® PCR Media tubes under ambient or refrigerated conditions. Do not freeze.
Causes for Rejection
Urine not submitted in cobas® PCR Media; under-filled or over-filled cobas® PCR Media tubes; leaking or broken tube; inadequate storage or transport
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 138880 | BKV Quant PCR (Urine) | 41480-5 | 139816 | BKV DNA, Quant PCR, Urine | IU/mL | 41480-5 |
| 138880 | BKV Quant PCR (Urine) | 41480-5 | 139817 | log10 BKV DNA, Urine | log10 IU/mL | 90924-2 |
| Order Code | 138880 | |||||
| Order Code Name | BKV Quant PCR (Urine) | |||||
| Order Loinc | 41480-5 | |||||
| Result Code | 139816 | |||||
| Result Code Name | BKV DNA, Quant PCR, Urine | |||||
| UofM | IU/mL | |||||
| Result LOINC | 41480-5 | |||||
| Order Code | 138880 | |||||
| Order Code Name | BKV Quant PCR (Urine) | |||||
| Order Loinc | 41480-5 | |||||
| Result Code | 139817 | |||||
| Result Code Name | log10 BKV DNA, Urine | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 90924-2 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 139820 | BKV Quant PCR (Urine) | 139821 | BKV DNA, Quant PCR, Urine | IU/mL | 41480-5 |
| Reflex 1 | ||||||
| Order Code | 139820 | |||||
| Order Name | BKV Quant PCR (Urine) | |||||
| Result Code | 139821 | |||||
| Result Name | BKV DNA, Quant PCR, Urine | |||||
| UofM | IU/mL | |||||
| Result LOINC | 41480-5 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 139820 | BKV Quant PCR (Urine) | 139822 | log10 BKV DNA, Urine | log10 IU/mL | 90924-2 |
| Reflex 1 | ||||||
| Order Code | 139820 | |||||
| Order Name | BKV Quant PCR (Urine) | |||||
| Result Code | 139822 | |||||
| Result Name | log10 BKV DNA, Urine | |||||
| UofM | log10 IU/mL | |||||
| Result LOINC | 90924-2 | |||||