Table 3.

Highlights From Eech Topic Area Discussed During WALEX

Topic Area: POCT Technical Requirements	Variables discussed
Patient acceptance of sampling location	Cervix, vaginal, penile, urethral and urine as sites Male preference for urine
Patient willingness to self sample	Acceptance of self collection of vaginal swabs by women ¹⁴ Acceptance and preference of urine (in a cup) by men Fewer bathrooms for collection in clinics for urine Home testing acceptance of urine
Sensitivity of sampling site	Organism load of urine, cervical swabs. Organism load associated with first urine versus entire urine stream Glans (male) is an insensitive site to collect by swab
Sample processing	Requirements for concentration of urine: more equipment, more steps, more training Use of self collection sponge or urine pellet on swab
Specificity and sensitivity	FDA regulates test approval FDA states new test must perform >95% sensitivity of current NAAT Chlamydia test¹⁵ Use two test system to capture and immediately treat positives and confirm negatives by more sensitive test Asymptomatic nature of Chlamydia is problematic in physician choice for testing and syndromic treatment model Lower specificity tests may result in faster detection and treatment of positives No false positives required for fast test for Chlamydia False positive and negative rates are driven by prevalence of disease in population Different Chlamydia disease prevalence rates need different specificity and sensitivities
Time to result	Patients want result in 5 minutes but will accept 20 minutes ED physicians will accept up to 4 hours to fit with clinic flow Public health laboratories want POCT to fit with clinic visit flow (<1hr) Many patients tested for Chlamydia do not return for results
Other	Use of screening tests versus confirmatory testing Unacceptablity of terms: screening and confirmatory tests since results are used in the same way for treatment
Topic Area: POCT Transition to Commercial Project	Variables Discussed
CLIA/FDA approval	Both FDA has oversight in categorization of CLIA tests User community for CLIA waived and FDA approved tests have different levels of implied expertise Clearance/approval requires new test have 95% agreement with reference test Low complexity tests are candidates for CLIA waived tests Reference test can be selected from any clinically approve tests performed by trained professional
Unit Size Packaging	Devices need to run tests in parallel Batch tests for POCT require high volume and may not be appropriate for all settings Flexibility in number of samples is needed to address variations in patient flow
Quality controls	If quality controls are built into every run method they must be run with each batch as defined by manufacturer’s instructions CLIA inspectors not users define “a run” or required periodicity of controls Manufacture’s definitions of periodicity do not support clinical assay work flow Manufacturer should design controls and stability testing to support “lot level” testing not “shipment level”.
Topic Area: Risk Assessment and Cost	Variables Discussed
Cost structure	Costs per test are dependent on volume of tests produced Cost of POCT are dependent on whether another test is required to confirm result Costs of $30 are too high for screening test If number of people were being tested that CDC recommends, volume of tests would increase Current NAATs test cost approximately $15
Multiplexed test	Combining tests is a strategy for reducing cost Multiplex tests are only good if co-prevalence rates are high Multiplex tests costs which are three times the cost of a single assay are unacceptable
Topic Area: Market Acceptance	Variables Discussed
End users defined	POCT end users defined as physicians, clinicians and patients Clinical laboratorians defined “the lab” (themselves) as end users in order to provide greatest cost control CLIA waived tests would be appropriate Internet can be used to market tests directly
Drivers for Chlamydia POCT	POCT should be available as off the shelf product “at the supermarket” Privacy is driver for Chlamydia tests Package inserts describe the target for use of the test (who should be tested) but do not describe where test should not be used.
Home testing	Patient focus groups indicate they would accept test with high false positive rates if they could perform themselves Problems in home testing are seen when patients self medicate based on test results Home sampling combined with mailers for testing at central location would be acceptable