DETERMINE™ TB LAM Ag
27 | Mar | 2023
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>50% of PLHIV Remain Undiagnosed for TB
Limitations of the current testing tools Millions undiagnosed and untreated
60% of patients with extrapulmonary (eptb) do Only 56% of PLHIV estimated to have TB in 2019
60% not have traceable TB in the lungs and sputum.15 56% were identified and reported.18,19
>30% of PLHIV have sampling challenges and >60 % of children and young adolescents couldn’t
30% cannot produce sputum for molecular testing.16 60% access life-saving TB diagnosis and treatment in
2020.20
For children below the age of 6, sputum is induced Patients spend up to 7 weeks before they are
by an invasive procedure.17 diagnosed using current testing methods.21
7
Sputum is an infectious sample, requires processing
and poses a greater biohazard risk.18
Substantial infrastructure and implementation
resources needed for molecular testing.18
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Burden of TB in PLHIV
60% 50%
214,000 60% chance 50% chance
TB deaths that HIV positive adults that children living with
among PLHIV in 2020, an
will acquire TB in the first 2 HIV will acquire TB in the
increase for the first time in
years post diagnosis23 first 2 years post
over a decade due to COVID-
diagnosis23
19 disruption to TB services
and underfunding22
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PRODUCT OVERVIEW
Product Specifications
RAPID SAMPLE39 POINT-OF-CARE STORAGE
(POC) TEST40 SHELF LIFE21
DIAGNOSTIC TEMPERATURE39
TEST39 Urine Requires minimal 2-30C 17 months
Time to result: infrastructure and
25 min training (ie, suitable
for patient bedside in
hospital or primary
care clinics)
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PRODUCT OVERVIEW
Items Required for Testing
PROVIDED IN DETERMINE TB LAM Ag KIT
ADDITIONAL ITEMS NEEDED
Urine collection cup
Reference Scale
Card
Pipette to deliver 60 μL
volume of urine
25 Tests, packaged as Timer
5 cards with 5 tests per card
Package insert (PI)
with instructions
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PRODUCT OVERVIEW
Simple Procedure
Prepare & Perform
1 2 3
PREPARE TEST PLACE TEST ADD SAMPLE
BEFORE Product Information
YOU BEGIN
•Please read the package insert in -------- Lot Number
Patient Identification Caution: Do not lift the
Area
its entirety prior to use. -------- Product Name
capillary tube from the
sample pad before all the
•Gather materials you will need. urine has been
transferred.
•Cover your work space with a
clean, disposable, absorbent
Control Line Area
workspace cover. Patient Test Result
Read Results
Area
•Put on your disposable gloves.
•All components must be brought
to room temperature (between Sample Pad Area
4
READ RESULTS
Wait 25 minutes and
read the results.
5 CHECK RESULTS
6 TEST RESULTS INTERPRETATION
15°C–30°C) prior to testing. 1/ R 01401706
06740101/ R 1
LINE POSITIVE NEGATIVE INVALID
25 - Control
-
min
RD
Result Key
TB LAM Ag
AgLECA
REFERENCE SCALE CARD
+
+
SCA
™
AMCE
DETERMINE™
L TB
DETERMINE
REN REFE
Patient
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7
PRODUCT OVERVIEW
Clinical Benefits
>50% Increase in Diagnostic Yield With Integrated Testing Using TB LAM43
59%
increase
in diagnostic yield
54.2%
increase
in diagnostic yield
17-24%
TM
Determine TB LAM Ag day 1 diagnostic yield in HIV+ve inpatient higher
compared to Xpert and Smear15
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PRODUCT OVERVIEW
Rapid and Ease of use
TB LAM lateral Rapid flow Feasibility of using TB LAM in
25 Time to results 25 mins
programmatic conditions42
mins
4X FASTER
Molecular test
100 mins Time to results ~100 mins LAM users’ responses on the ease of performing each step of the LAM test (N =
32).
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PRODUCT OVERVIEW
Clinical Benefits
15% Reduction in Mortality Risk in Inpatient Settings
Impact of diagnostic strategies for tuberculosis using lateral flow urine
lipoarabinomannan assay in people living with PLHIV.44
LF-LAM impact on
34 fewer deaths per 1000 linkage to TB treatment
In outpatient settings, the use of LF LAM could
Advanced HIV patients admitted.
result in a large increase in the proportion of PLHIV
started on tuberculosis treatment.
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PRODUCT OVERVIEW
DETERMINE TB LAM Ag is a diagnostic innovation
Cost effective; Instrument free
Non-invasive procedure; non-infectious
& unprocessed urine sample
Clinical utility: At all
Simple POC technology; little training levels of healthcare
and no sample preparation required
Fast, result in 25 mins
TIME TO TB LAM RESULTS TIME TO MOLECULAR /
25 MINS X-RAY RESULTS
1-3 DAYS
TB TREATMENT BEGINS IN TB TREATMENT BEGINS IN
2.42 HOURS DELAYED
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