Comparison of Automated Platforms for STI Testing: Continuous Random Access vs. Batch Testing

Max Chernesky, PhD, with a Panther® System customer review by Robyn Thon MT(ASCP)

References: 1. Liverani CA, et al. Am J Transl Res 2012; 4(4): 452-457 2. References available at www.gen-probe.com/products-services/aptima-hpv-assays 3. Aptima® HPV assay package insert # 503789 Rev A 2013 Table 22.

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CERVICAL CANCER SCREENING

Cervical cancer screening has evolvedThe Aptima® HPV assay is now available on the Panther® system. The Aptima® HPV assay detects HPV mRNA. Studies show HPV mRNA is indicative of infections that may lead to disease.1

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• Excellent sensitivity — Demonstrating similar sensitivity to DNA-based HPV tests in multiple clinicalstudies involving approximately 45,000 women worldwide.2

• Improved specifi city — Reducing false-positives by 24% in the clinical trial.3

• Workfl ow freedom and total control — Expanding the women’s health menu on a fully automated platform.

Interested in learning more about the Aptima HPV assay and the Panther system? Contact us.

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Comparison of Automated Platforms for STI Testing: Continuous Random Access ���

vs. Batch Testing

Max Chernesky

St. Joseph’s Healthcare/McMaster University, Hamilton, ON

Making an Informed Decision

Cost per Test

Equipment Cost

Hands on Time

Consumable Cost Labor Cost

Space Requirements

Time to Result Return Visits

.

Maintenance

Test Capacity

3

Making an Informed Decision ���Workflow studies give quantifiable and objective metrics

Workflow Studies

Hands on Time

Time to Result

Maintenance

Time

Test Capacity

Return Visits

4

Automated and Semi Automated Instruments

Batching

m2000 Abbott

Viper XTR Becton Dickinson

cobas 4800 Roche

Tigris Hologic|Gen-Probe

Continuous Random Access Panther Hologic|Gen-Probe

m2000 (Abbott) •  Batching •  Separate units for specimen extraction (m2000sp) and detection (m2000rt)

•  93 specimens per run with return visits

6

Viper XTR (BD) •  Batching •  Single unit for specimen extraction and detection •  Max 92 specimens processed per batch without a return visit

7

cobas 4800 (Roche) •  Batching •  Separate units for specimen extraction (x480) and detection (z480)

•  94 specimens per batch

8

9

Tigris (Hologic) •  Batching •  Single unit for specimen extraction and detection

•  Max 176 (9 racks x 20) specimens processed per batch

•  Non-batch random access •  Single unit for specimen extraction and detection

•  Max 118 (8 racks x 15) specimens initially with continuous feed 10

Panther (Hologic)

Methods

•   2 investigators travelled to each testing site for a 96-test run

•   Second visit timed 192 tests •   Both vaginal and urine samples were tested

for C. trachomatis

11

Study Parameters (96 and 192 tests) 1.   Total Hands-on Time���

Total time required for manual interaction including daily maintenance

2.   Return Visits��� Number of times operator is required to return to the instrument

3.   Time to Result��� Time from start-up to first and final result

4.   Maintenance��� Cumulative hands-on time required for daily, weekly, and monthly maintenance based on 20 testing days

12

Hands-on Time

1.   Pre-analytical Interactions 2.   Reagent Preparation and Loading 3.   Sample Preparation and Loading 4.   In-Process Interactions (Return Visits) 5.   Post-analytical Interactions 6.   Daily Maintenance

13

Normalization •   Some instruments are designed to process

more than 96 or 192 tests •   e.g. pre-analytical waste management in Tigris

took 7 min 12 sec for every 1000 tests������normalized time for 96 tests

•   = 7 min 12 sec x 96��� 1000���= 41.5 sec

14

1:00 0:58

2:09

Δ71

m2000

1:41

2:17

Δ37

Viper XTR

Δ58

0:40

1:38

cobas 4800

0:28

Δ6

0:34

Tigris

0:21

Δ12

0:33

Panther 0:00

0:30

1:30

2:00

2:30

Total Hands-on Time for 96 and 192 tests (h

:mm

)

15

4:55

5:58

Tigris

2:00

4:00

6:00

8:00

5:27

7:01

10:00

6:11

9:57

m2000

3:31

5:08

Viper XTR

4:23

6:08

cobas 4800

Panther 0:00

(h:m

m)

Time to Results for 96 and 192 Tests

Time to First Results

Results Results Results Results Results

Results Results Results Results Results Results Results Results Results Results

16

Cumulative Hands-on Time for Maintenance Based on 96 Tests Per Day, 20 Days Per Month

2:30

5:00

7:30

10:00

12:30

15:00

17:30

20:00

22:30

m2000 Viper XTR cobas 4800 Tigris Panther 0:00

Daily maintenance Weekly maintenance

Monthly maintenance

17

(h:m

m)

575 Women (SCVS)

FVU cobas 4800 Aptima

RealTime Qx

* * * * *

*spiked with C. trachomatis

X 4 assays

18

Objectives

•   Determine the analytical sensitivity of each assay for detection of C. trachomatis in vaginal swab samples and urine

•   Test each sample with a CT spike to detect inhibitors

•   Calculate sensitivities and specificities based on a Patient Infected Status (PIS)

19

Determination of Analytical Sensitivity

AC2 CT/GC

CT/NG RT m2000

CT/GC ProbeTec Qx

cobas 4800 CT/NG

Dilution of CT SCVS FVU SCVS FVU SCVS FVU SCVS FVU

10-5 10/10 10/10 10/10 10/10 10/10 10/10 10/10 10/10

10-6 10/10 10/10 4/10 6/10 10/10 4/10 4/10 10/10

10-7 10/10 10/10 0/10 0/10 2/10 0/10 0/10 6/10

10-8 6/10 4/10 0/10 0/10 0/10 0/10 0/10 0/10

10-9 0/10 0/10 0/10 0/10 0/10 0/10 0/10 0/10

Probit LOD50 -8.1 -7.9 -5.9 -6.1 -6.7 -5.9 -5.9 -7.1

% Inhibitors 0.3 0.5 0.0 0.0 4.5 2.3 0.0 0.0

20

575 patients 54 PIS +ve 53 VS + 48 FVU +

Patient Infected Status (PIS) = positive in at least 2 assays

21

Comparison of Sensitivity and Specificity ���of SCVS for C. trachomatis

22

Sensitivity and Specificity for C. trachomatis FVU Excluding 4 Urine-Negative Women (%)

47/49 44/46 40/48 40/49 43/49

23

•   AC2 on Panther or Tigris identified more Chlamydia infections than the other assays

•   Vaginal swabs were superior to urine •   Panther and Tigris had substantially less hands-on time

for 96 and 192 tests •   All platforms produced 192 test results in a normal

workday except for m2000, which were generated into the next work shift

•   Viper had the shortest time to results (96/192 tests), but highest daily maintenance

•   The “non-batching” Panther allowed continuous access to reagents and samples with greater workflow efficiency

24

We did it: One Laboratory’s Experience

Robyn Thon, M.S. , M(ASCP) Columbia St. Mary’s – Milwaukee Hospital Laboratory

Decision ! Can we implement molecular testing

at Columbia St. Mary’s?

Key Issues ! Space? ! Who? ! What? ! How? ! Price/Savings? ! Training?

Space ! Did we have the facilities at our

disposal to even consider molecular testing?

!  In the past, the recommendation was to have two separate rooms or areas available for work flow and cleanliness.

! Did we have the space? ! With the Panther, there is no need for

separate work areas.

Sample handling DNA preparation

Clean room Stock solutions

Laboratory Mixing site

Thermocycler Amplification

Detection Documentation

Molecular Laboratory of the PAST!

Who? ! Who would be involved in doing the

testing? ! Did they have the level of expertise

necessary or could they learn? ! Where does this testing fit the best? ! Could it be done without adding

FTE’s?

What? ! What testing did we want to perform? ! Were there any that were high

volume? ! Were there multiple tests on the same

platform? ! Did any cross disciplines?

Current GC/Chlam Diagnostic Tests: !  Non-amplified !  Hologic/Gen-Probe Aptima (TMA) !  Qiagen Hybrid Capture 2 !  Roche Cobas 4800 (PCR) !  B-D ProbeTec Qx (SDA) !  Culture !  Antigen Detection Tests: EIA, DFA

How?

How (cont.) ! We determined it would be best to

invite three vendors in for presentations.

◦  quality (sensitivity/specificity) ◦  functional ease ◦  collection devices

How (cont.) ! Each of the three vendors presented

an equally good product ◦ So we had to determine, which one we

liked best. ◦ We involved the techs in the selection

process. ◦ We went on site visits.

Price? ! We worked with each of the vendors to

get their lowest price. ! Performing in house vs. send out

testing ◦ Approx cost $20/test in house vs. $40/test

to send out. ◦ Based on volume this would approximate

a $80,000/year savings.

We chose the Panther

Training? ! We determined that we would train all

staff. ◦ Both first and second shift ◦ Proficiency/Competency ◦ Scheduling

Success? ! Test volume has increased generating

greater savings. ! We have continued to bring in more

testing. ! With our success, we felt comfortable

bringing in additional platforms. ! Staff satisfaction with more testing

knowledge.

Questions/Comments? ! Robyn Thon ◦  rthon@columbia-stmarys.org ◦  414.291.1412