CEPHEID
904 Caribbean Drive, Sunnyvale , CA 94089, United States
Phone: 888-838-3222, Option 1
Email: ordermanagement@cepheid.com |
http://www.cepheid.com/
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CORPORATE DESCRIPTION:
Our mission is to enable molecular diagnostic testing of any patient specimen on a centralized or disseminated basis, thereby enabling medical providers to identify and treat diseases early, increasing opportunities to improve patients’ survival and quality of life. |
TEST KITS:
| Test Kit Name |
Xpert® Xpress Flu |
Xpert® Xpress Flu/RSV |
Xpert® Xpress Strep A |
| |
 |
 |
 |
| CLIA Classification |
CLIA Waived
Moderately complex
|
CLIA Waived
Moderately complex |
CLIA Waived
Moderately complex |
| Analytes performed |
Flu A, Flu B |
Flu A, Flu B, RSV |
Strep A |
| CPT Code associated with each analyte |
87502, 87502-QW |
87631-QW*, 87502-QW**, 87634-QW***
87631*, 87502**, 87634***
* If all targets ordered by healthcare provider at same time.
** If only Flu is ordered.
*** If only RSV is ordered |
87651-QW, 87651 |
| Test methodology |
Reverse Transcription PCR |
Reverse Transcription PCR |
Reverse Transcription PCR |
| Sample volume |
300 µl |
300 µl |
300 µl |
| Time to result |
30 minutes |
30 minutes |
30 minutes |
| Units in which the test is reported |
Positive or negative |
Positive or negative |
Positive or negative |
| MSDS's |
Xpert Flu Assays Safety Data Sheet |
Xpert Flu Assays Safety Data Sheet |
Xpert Strep A Assay Safety Data Sheet |
INSTRUMENT REQUIREMENTS:
| Instrument Name |
GeneXpert® Xpress II |
GeneXpert® Xpress IV |
GeneXpert® II |
GeneXpert® IV |
GeneXpert® XVI |
GeneXpert® Infinity |
| |
|
|
|
|
 |
 |
| Model Name |
GeneXpert Xpress II Tablet PC |
GeneXpert Xpress IV Tablet PC |
GeneXpert Xpress II Laptop |
GeneXpert Xpress IV Laptop |
GeneXpert Xpress XVI Laptop |
GeneXpert
Infinity-80 |
| CLIA Classification |
CLIA Waived |
CLIA Waived |
Moderately complex |
Moderately complex |
Moderately complex |
Moderately complex |
| Size and Weight |
6.35" w x
12.00" h x
11.70" d
15 Ibs |
11.00" w x
12.00" h x
11.70" d
25 Ibs |
6.35" w x
12.00" h x
11.70" d
15 Ibs |
11.00" w x
12.00" h x
11.70" d
25 Ibs |
22.75" w x
25.80" h x
13.25" d
125 lbs |
108” L x 35” w x
78.5” h
2,100 lbs |
| Specs |
Voltage
100-240 V~, 50-60 Hz
Current
1.5A @ 100V~, 0.75 A @ 200V~ |
Voltage
100-240 V~, 50-60 Hz
Current
1.9A @ 100V~, 0.95 A @ 200V~ |
Voltage
100-240 V~, 50-60 Hz
Current
1.5A @ 100V~, 0.75 A @ 200V~ |
Voltage
100-240 V~, 50-60 Hz
Current
1.9A @ 100V~, 0.95 A @ 200V~ |
Voltage
100-240 V~, 50-60 Hz
Current
8.24A @ 100V~,
4.12 A @ 200V~ |
Voltage
100-240 V~, 50-60 Hz
Current
Max Current 16 amps @ 200 VAC |
| Data transfer capability |
HL7/ASTM |
HL7/ASTM |
HL7/ASTM |
HL7/ASTM |
HL7/ASTM |
HL7/ASTM |
| Features |
Scalable Design; Random Access; Standardized GeneXpert Technology; Simple test workflow; Operator
authentication; QC lockout; No IQCP; LIS Connectivity; Cepheid C360 |
| Test Menu (analytes that can be performed on instrument) |
Xpress Flu,
Xpress Flu/RSV,Xpress Strep A |
Xpress Flu,
Xpress Flu/RSV,Xpress Strep A |
US-IVD menu |
US-IVD menu |
US-IVD menu |
US-IVD menu |
| CPT Code for each analyte |
87502-QW,
87631-QW,
87798-QW,
87651-QW |
87502-QW,
87631-QW,
87798-QW,
87651-QW |
Various LOINC |
Various LOINC |
Various LOINC |
Various LOINC |
| Test Methodology |
Reverse Transcription PCR |
| Units in which test result is reported |
Positive or negative |
Positive or negative |
Positive or negative |
Positive or negative |
Positive or negative |
Positive or negative |
SOFTWARE INFORMATION:
Instrument Name |
GeneXpert® Xpress II |
GeneXpert® Xpress IV |
GeneXpert® II |
GeneXpert® IV |
GeneXpert® XVI |
GeneXpert® Infinity |
Model Name |
GeneXpert Xpress II Tablet PC |
GeneXpert Xpress IV Tablet PC |
GeneXpert II
Laptop |
GeneXpert IV
Laptop |
GeneXpert XVI
Laptop |
GeneXpert
Infinity-80 |
| Software Name |
GeneXpert Xpress |
GeneXpert Xpress |
GeneXpert Dx |
GeneXpert Dx |
GeneXpert Dx |
Xpertise |
| Version # |
5.0 |
5.0 |
4.8 |
4.8 |
4.8 |
6.6 |
| Included download capability |
No |
No |
No |
No |
No |
No |
| Operating system capability |
Windows 7 Professional SP1 64 bit |
Windows 7 Professional SP1 64 bit |
Windows 7 Professional SP1 64 bit |
Windows 7 Professional SP1 64 bit |
Windows 7 Professional SP1 64 bit |
Windows 7 Professional SP1 64 bit |
| Administration features |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| User features |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| QC features |
Yes |
Yes |
No |
No |
No |
No |
| Instrument Management features |
No |
No |
No |
No |
No |
No |
| Inventory Control features |
No |
No |
No |
No |
No |
No |
| Reporting features |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| Export capability |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| LIS Interface capability |
Direct interface (HL7, ASTM)
Sunquest, Cerner, Meditech, Epic, SCC Soft, Orchard, RALS, Telcor, RelayMed, UniPOC, AQURE |
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