1

Chapter 1: Global and National Overview of TB, TB/HIV and

DR-TB

Duration: 1hr sand 30 minutes.

Chapter Objective:
By the end of this chapter the participants will be able to:
Describe the recent global and national TB, TB/HIV and DR-TB burden,
performance of national TB program and the laboratory network system.

Enabling Objectives:
At the end of this chapter participants will be able to: -
 Describe the global and national burden of TB, TB/HIV and DR-TB
 Explain the global performance towards End TB strategy milestones and targets
 Discuss the performance of national TB and DR-TB program
 Discuss the national TB laboratory network system
 Explain the impact of COVID-19 on TB detection and access to care

Summary of activities
S. N Activity Method of delivery Time Slide
Number
1.1 Overview of Global TB, TB/HIV and DR- Interactive lecture and 10 minutes 5-8
TB burden Individual reflection

1.2 The End TB Strategy milestones and targets Interactive lecture and 10 minutes 9-12
Think /pair /Share
1.3 TB, TB/HIV and DR-TB Epidemiology in Interactive lecture and 20 minutes 14-20
Ethiopia Group discussion
1. 4 National TB program performances Interactive lecture and 30 minutes 22-31
Group discussion
1.5 National laboratory network Interactive lecture and 5 minutes 34
reflection
1.6 The impact of COVID 19 pandemic on TB Interactive lecture and 10 minutes 35
detection and access to care individual reflection

1.7 Chapter Summary Lecture 5 minutes 37

Resources needed:
● Flip chart and markers

2
 ● LCD projector and laptop

● Participant Manual

In advanced preparation
 Prepare blank fillip chart or white board different color markers

Learning activities

S. N Topic Time Activities

(Min)

 Start with introducing yourself to the participants

(your name, profession, experience…) and
1 Overview of Global TB,
organization.
TB/HIV and MDR-TB
 Give chance for the trainees to introduce themselves
Epidemiology: Name, profession, organization they came from and
experience if they think it is necessary.
 Power point presentation
 Quickly go to the power point and tell to the
and
participants about the objectives of the module
 Individual reflection  Introduce the topic by asking the recent global TB,
TB/HIV and DR-TB incidence and the main
10 determinants of TB burden by displaying slide
number 4.
 After receiving two or three answer/ feeling from the
participant;
 Explain the recent global TB, TB/HIV and DR-TB
incidence and the main determinants of TB burden by
displaying slide number 5 to 8
 Invite the participants to interpret the numbers that
displayed in tables and figures during presentation
 Request the participant in order to reflect on the topic
within 2 minutes
 Recap the topic within 2 minutes

3
2 
The End TB Strategy
milestones and targets:
 Interactive lecture and
 Think/pair/share
3 TB, TB/HIV and DR-TB burden
in Ethiopia
 Interactive lecture and
 Group Discussion
4 National performances
evidences of TB and MDR-TB
 Interactive lecture and
 Group Discussion
Display slide 13 (activity 1.2) and let your trainees to
think and for 2 minutes and allow them to discus in
pair and write their answer on notebook about the
question for another 2 minutes and ask 5 participants
to answer the question by random. Display slide 13
10 respectively then
 Ask the participants whether the targets are achieved
or not.
 Present the power point number 9-12 and 12 to
summarize what the participants listed on the global
targets related to TB, TB/HIV and DR-TB.
 Display slide 21 (activity 1.3 group discussion) and
order your trainees to form five groups which have 5-
6 participants then give 10 minutes for reading
&discussion and 2 minutes for each group for
20
presentation. Select one participant from each group
by random & Invite them for presentation with in the
given time each.
 Display slide 14-20. Explain for participants the TB,
TB/HIV and DR-TB burden in Ethiopia
 Finally recap/summarize the key about that indicator
of the burden of TB in Ethiopia.
and  Request/invite the participants to reflect/ tell the national
vision, goals and targets to end TB in Ethiopia.
30
 Invite the participants to comment the national TB
performance, focusing on TB diagnosis and case
detection rate
 Describe the national TB program performance in detail
on national TB diagnosis and case detection rate using
slide number 22 – 26
 Display slide number 27-31also present for the
participant GeneXpert utilization rate calculation &
4

5 National TB laboratory
network system
 Interactive presentation
and
 Individual reflection
6 The impact of COVID 19
pandemic on TB detection
 Interactive lecture and
 Think/pair/share
points to be considered to calculate GeneXpert
utilization rate
 Display slide 32 (activity 1.4 ) and order your
trainees to form five groups which have 5-6
participants then give 10 minutes for reading
&discussion and 2 minutes for each group for
presentation. Select one participant from each group
by random & Invite them for presentation with in
the given time.
 Summarize the key national TB program performance
focusing on TB diagnosis and case detection and group
activity focusing on GeneXpert expansion and
utilization, how to calculate GeneXpert Utilization rate &
the point to be considered for calculation of utilization
rate.
 Request the participants to discuss on the national laboratory
network system and roles of each tier on TB diagnosis. List
the response of the participants on the fillip chart or white
5 board
 Explain the national laboratory network system and their
responsibilities in TB diagnosis at each level by displaying
slide number 34.
 Summarize the national laboratory network system and the
responsibilities of each tier within 2 minutes
10  Display slide number 35, Ask the participants whether
COVID-19 negatively impact on TB case detection and
access to care during the outbreak. If the participants agreed
on the negative impact of COVID-19 on TB case detection
and access to care,
 Invite the participants, what the impacts are and how many
percent of TB case detection reduced in Ethiopia.
 Explain the impacts of COVID-19 on TB case detection and
5
 access to care at global and national level using slide number
36.
 Recap the topic within 2 minutes

7  Summary 5  Summarize the key points raised in this chapter within 5

minutes using slide number 37.
 Finally take any questions and comments, if any

Answer key

Activity 1.1 Individual reflections

Answer

1. 10 million or 130 per 100,000 population in 2019

2. HIV infection, diabetes mellitus, other comorbidities etc.

Activity 1.2 Think/pair/shar

Answer

1. B: The reduced amount is less than 50%

2. The targets will not be achieved in many high burden countries, if the speed of burden
reduction is continued in the current situation

Activity 1.3 Group discussion

Answer
157,000 x 100,000
1. Incidence of TB per 100,000 = =140.2 per 100,000 population
112,000,000
10,000
2. The percent of TB in HIV positive people in Ethiopia = x 100 % = 6.4%
157.000
Activity 1.4 Group discussion
Answer

Given:
6
1. Total number of machine with their modules number 250 machines with 4 modules. The
total number of modules = 250 x4 = 1000
Total number of failed modules in a given years = 198
Total number of functional module 1000 – 189 = 811
Number of working days in a given year is 21 days/month. The total number of
working days in a given year = 21 x 12 = 252 working days in a year
Target test performance per module in a day is 3
The annual expected tests in 2018 = 252 x 3 x 811 = 613,116
The total test done in 2018 in Ethiopia = 397,800

Total failed modules∈agivenyear

Solution: Module failure rate = X 100 % =
Total modules∈the same year
189
X 100 % = 18.9%
1000

GeneXpert MTB machine utilization rate:

Total test done∈2018

Utilization rate∈2020= x 100 %
Annual expected tested ∈2018

397,800
Utilizationrate∈2020= x 100 % = 64.9%
613,116
Activity 1.5 Individual reflections
Answer
1. Yes
2. 23.6%
3. People with presumptive TB may not come to health facility to seek treatment
although they have symptoms of TB due to fair of COVID-19. In addition, after
they have diagnosed for TB, they may not come for treatment follow up due to the
fair of COVID-19.
4. As a result TB detection rate and access to care could decrease. To minimize the
impact of COVID-19 on TB case detection and access to care, engagement of
politicians, health workers, communities, civil society and other partners on
advocacy are important to ensure continuity of essential TB services during the
COVID-19 pandemic.

7
Chapter 3: Biosafety for Xpert MTB Assays

Duration: 1:15 hrs

Chapter description This chapter describes the biosafety measures required for Xpert
MTB/RIF(Ultra) and MTB/XDR assays during pre-examination,
examination and post examination including waste disposal

Chapter objective At the end of this chapter, participants will be able to apply general
8
 TB laboratory softy measures as per the recommended guidelines.

Enabling objectives At the end of this chapter, participants will be able to:
 Describe safety risks and Biosafety
 Explain essential biosafety measures used during Xpert MTB
testing
 Identify general code of practice in the laboratory
 Explain emergency response procedures for spills and leaked
specimen
 Describe the GeneXpert MTB laboratory waste disposal

Summary of Activities
SN Topics Method of Materials needed Time Slide
delivery Number
3.1 Risk of TB infection Interactive LCD projector and 20 4-11
. and Biosafety Presentation, laptop, flip chart minutes
and Self and marker
reflection
3.2 Essential biosafety Interactive LCD projector and 20 12-19
. measures Presentation, flip chart and minutes
and marker
Think/pair/sh
are
3.3 Classification of Interactive LCD projector and 5
. activities during Xpert Presentation, , flip chart & minutes
MTB testing and Self marker 20
reflection
3.4 General code of Interactive LCD projector and 10
. practice in the Presentation , flip chart and minutes 21 & 22
laboratory and marker
Think/pair/sh
are

9
3.5 Emergency response Interactive LCD projector and 15 min
. procedures for spills Presentation, laptop 23-27
and Waste disposal and Self
reflection
Chapter Summary Interactive LCD projector and 5min
Presentation laptop 28
and Question
Answer

Advanced Preparation: Read Participant Manual, PowerPoint and references sited for
this chapter.

Learning Activities
S Topic Time Activities
N
 Introduce yourself for the participants
3. Risk of TB infection (name, profession and working organization)
1 and Biosafety 20  Display chapter outline and elaborate chapter
Minutes objective on Slide No 2-3.
 Tell participants to reflect their idea on the
given self-reflection question Slide No 4.
 Self-Reflection Allocated time is 7 minutes.
 Interactive Introduce the content of the Chapter properly
Presentation for the participants to and clearly define
Biosafety, importance of safety and risk of TB
infection during Xpert MTB testing. Slide No
5-11.
 Check participants if there is any unclear part.
 Ask the participants to pair with a person
3. Essential biosafety sited next them and share idea to answer:
2 measures 20 Activity 3.2 on slide No 12. Allocated time

10
 Minutes is 5 minutes.
 Interactive
Presentation  Display the slide 12-19 and clearly describe
essential biosafety measures required with
 Think/Pair/Share their detail description. Total allocated time
is 15 minutes.
 Ask participants if they have question.

3. Classification of Display Slide No 20 and elaborate

3 activities during Xpert 5 Minute Classification of activities during Xpert MTB
MTB testing s testing. Total allowed time is 5 minutes.

 Interactive
Presentation

3. General code of  Tell participants to reflect their idea on

4 practice in the 10 the given self-reflection question Slide
laboratory Minutes No 21. Allocated time is 3 minutes.

 Display the slide No 22 and explain

General code of practice in the
 Interactive laboratory; give clear explanation for
Lecture each of them. Allocated time is 7
minutes.
 Self-Reflection

3. Emergency response  Ask the participants to pair with a person

5 procedures for spills 15 sited next them and share idea to answer:
and Waste disposal Minutes Activity 3.4 on slide No 23. Allocated time
is 5 minutes.

 Interactive  Display the slide 24-27 and clearly List the

11
 Lecture contents of spill kits and how to manage
 Think/Pair/Share specimen leaked on the working bench or
spill in the lab, and also explain how to
manage(segregate and dispose) wastes
generated in the laboratory. Total allocated
time is 10 minutes.
 Ask participants if they have question.
3. Summary 5  Display the chapter summary on slide No 28.
6 Minutes 3 minutes.
 Give opportunity for participants to ask
questions. 2 minutes.

12
Chapter 4: TB Specimen Collection, Packaging and Transportation
Duration: 100 Minutes
Chapter Description: This chapter is designed for participants to improve how to
manage essential principles of specimen collection, packaging and transportation.

Enabling Objectives
By the end of this chapter participant will be able to
 Identify appropriate specimen collection containers
 Conduct safe and appropriate specimen collection

13
  Detect features of good quality sputum specimen
 Practice appropriate specimen labeling and Laboratory records system;
 Apply safety precaution during specimen collection, handling and transportation
 Perform proper specimen packaging
 Organize each specimen Referral document and records.

Summary of Activities
S.N Activity Method of Delivery Time Slide
. Number
Self-Reflection,
2-15
4.1 Specimen Collection and Interactive 25
. Labelling Presentation Minutes
Interactive
4.2 Quality Specimen Collection 16-21
Presentation, 20 Minutes
.
Role Play
Specimen Packaging and Interactive
4.3 22-34
Transportation Presentation, 35
.
Demonstration Minutes

Safety in Specimen Collection, Interactive

35-42
4.4 Handling, Transporting and Presentation, 25
. Receiving Role Plays Minutes
4.5 Document and Records in Think/Pair/Share,
43-52
. Laboratory Specimen Referral Interactive 15
System Presentation. Minutes
Summary Presentation, and 5 53
Question Answer
Minutes
Advanced Preparation: Read Participant Manual and PowerPoint, Print and distribute check list
of for demonstration role play for all trainees during activity time.
Learning Activities
S Topic Time Activities
N
 Introduce yourself for the participants

14
1 Specimen Collection (name, profession and working organization)
and Labelling 25  Display chapter outline and elaborate chapter
objective from Slide No 2-3.
Minutes
 Tell participants to reflect their idea on the
given self-reflection question Slide No 4.
Allocated time is 5 minutes.
 Self-Reflection Explain in detail for participant what specimen
 Interactive collection means, what specimen type is
Presentation required, how to produce appropriate specimen
and require amount of specimen volume, type
specimen collection material and containers,
what labeling means, what information should
be labeled and where to be label, benefits of
proper labeling, how properly identify and
instruct patients. Slide No 5-15.
 Check participants if there is any unclear part.
 Deeply describe what quality means, the
2 Quality Specimen importance of quality specimen collection, and
Collection 20 value of convenient and efficient specimen
Minutes collection and characteristics of quality
 Interactive
specimen. As well as clearly explain the type
Presentation
and difference of optimal and suboptimal of
 Role play
quality specimen from Slide No 16-20 and
time allowed 10 minutes.
 Display Slade No 21 Activity 4.2.
 Explain the activity for participants. Select
two volunteer participants, to play as one
participant to play as a Laboratory technician
and a patient character. Clearly explain to them
the role of their assigned character
responsibility. Print and distribute the role play
checklist for participants. Inform participants
to follow the role play and at last to review the
15
 role play what they understand, learn or have
comment. Total allocated time 10 minutes.
 Ask participants if they have question.
 From Slide No 22-33 show and elaborate
3 Specimen Packaging about what triple package mean and the three
and Transportation distinct parts, tell the required specimen
35 transporting and storage temperature, what
Minutes activities to be done during specimen
 Interactive packaging, transporting and receiving at each
Presentation specific place the requirement and
 Demonstration essentiality of writing each sputum specimen
identification as well as list of major rejection
criteria for sputum specimen. Describe to the
participant during specimen transportation
the obligation of follow and governed the
international and national rule and regulations
of infectious substance,
 Describe to participant the obligation of
follow and governed by the international and
national rule and regulations of infectious
substance, Total allowed time is 20 minutes.
 Display Slide No 34 activity 4.3. Clearly
explain for participant the demonstration
objective and what to do. For further
clarification can refer to Participant manual
activity 4.3.
 Print and distribute demonstration checklist
for participant and Inform participant to
listening the trainer and the selected
participant demonstration and at last based on
the given checklist they have a responsibility
to evaluate the demonstration activity.
16
  Primary you should explain for the selected
participant each distinct part of triple
package, show each step of packaging
process and what information should be
posted on the triple package, how to handle
and transport the specimen. Then ask him/her
if everything is clear and understood.
 Give the floor for the participant demonstrate
for all participant what you explain and show
to him/her.
 Ask participant what was the correct and the
mistake on the demonstration session.
Encourage participant to ask question.
4 Safety in Specimen  Display Slide No 35 and start interactive
Collection, Handling, 25 lecture. Define the meaning of safety explain
Transporting and Minutes the type of required safety during patient
Receiving instruction, how to protect the patient and the
specimen, type of personal protective
equipment and how to use these personal
protective equipment.
 Interactive Lecture
 Describe to them to apply every safety
 Role Play.
precautions starting from specimen collection
to transporting and delivering to testing
health facilities, aware about type of
Laboratory wastes and how to properly
differentiate, segregate and disposed
Laboratory wastes. State the essentiality of
recording every incident and type of action
taken, highly emphasize to give great
attention and concern for safety. Allocated
time is 10 minutes.

17

5 Document and
Records in Laboratory
Specimen Referral Minutes
System
6 Summary 5  Forward the chapter summary on slide No 53.
Minutes
 Show Slide No 42 Activity 4.4 Role Play.
 Select three participant to play a character of
Laboratory head, Laboratory technician and
specimen courier.
 Print and provide the role play checklist for
all trainees to evaluate the trainer explanation
and role-players performance. Clearly explain
each role-players responsibility and provide
to them to read the script.
 At the end of the role play what participants
observe, learn and evaluate. Discussed and
motivate participants to ask questions.
Permitted time is 15 minutes.
Display Slide No 43, Activity 4.5
15 Think/Pair/Share.
Describe for participants to pair with their side
seated person, think and share what they have
discussed for the larger group. Time allowed 5
minutes.
Present the interactive presentation from Slide
No 44 - 52. Explain what document and records
are, type of documents and records using
during specimen collection, handling and
transportation, what information to be recorded
in each record formats and how to manage
these documents and records. Time allowed is
10 minutes.
4 minutes.
 Give opportunity for participants to ask
questions. 1 minute.
18
Chapter 5: Supply Chain Management of GeneXpert
MTB/RIF (ULTRA) and XDR Assay
Duration: 2:10 Hrs. (130 minute).

Chapter Objective:
By the end of this chapter participant will be able to determine the basics supply chain
activities of Xpert MTB /RIF (Ultra) & XDR

Enabling Objectives:

By the end of this chapter participants will be able to: -

 Explain an Overview Supply Chain Management

 Explain the role and Responsibilities of Supply Chain Stakeholders
 Explain the Purpose of The Logistic Management Information System (LMIS)
 Fill out the Recording and Reporting of Xpert MTB/RIF Assays
 List the Equipment and Supplies Xpert MTB/RIF (Ultra) & XDR Assays
 Describe the Inventory Management Process of Xpert MTB/RIF Assay
 Describe the Storage and Distribution of Xpert MTB/RIF (ULTRA) & XDR kits
and other supplies

Summary of activities
S. N Activity Method of delivery Time Slide
Number

5.1 Overview of Supply Chain Interactive presentation 12 min 5–8

Management Individual Reflection
5.2 Role and Responsibilities of Interactive presentation 10 min 9 - 14
Supply Chain Stakeholders

5.3 Logistic Management Interactive presentation 60 min 15 – 25

Information System Think/Pair/Share
Individual Reflection
19
 Demonstrations

5.4 Equipment and Supplies for Interactive presentation 15 min 26 – 34

GeneXpert MTB/RIF (Ultra) Think/Pair/Share
and XDR Assay
5.5 Inventory Management Interactive presentation 15 min 35 - 40
Individual Reflection
5.6 Storage and Distribution Interactive presentation 13 min 41 - 47
Individual Reflection
5.7 Chapter Summary Interactive presentation 5 min 48 - 49

Resources needed:
 Flip chart and markers
 LCD projector and laptop
 Participant Manual
Advance preparation
 Read the Facilitator Guide, Participant Manual and the PowerPoint
Presentation.
 Make copies of Bin card and IFRR Form: Prepare printed 30 form each for Bin
card and IFRR.
 Rehearse the facilitation including the exercise

Learning activities

S. Topic Time Activities

N (Min)

1 Overview of Supply 12  Introduce yourself to the participants (your

Chain Management name, profession, experience (if you think it is
 Interactive important for the training) and organization
presentation
 Displaying slide 1.
 Individual
Reflection  Show the chapter outline of the presentation on
slide 2.
 Review the enabling objectives by displaying
slide 3-4
 Display slide 5. Activity 5.1 (Self Reflection)
20
 Tell all participants to write their answer on
their notebook give those 2 minutes. Then give
chance for 3 participants to reflect their answer
about the question in slide 5 for a total of 3
minutes.
 Open slide 6 - 8 and explain about overview of
Supply chain management and Logistic Cycle
and issues during supply interruption. Inform
your participants to refer participant manual to
read on Overview of supply chain management.
 Give a chance to your trainee to ask questions
about the topic.

2 Role and 10  Display slide 9 - 14 respectively then tell them

Responsibilities of the role responsibilities of supply chain
Supply Chain
Stakeholders stakeholders on Xpert MTB/RIF (Ultra) and
XDR Assay.
 Interactive
Presentation  Advise your trainees to refer on training
manual.

3 Logistic 60  Display Slide 15 explain the logistic

Management
management information and its components.
Information System
 Display slide 16. (Activity 5.2) and let your
 Interactive
trainees to think and for 2 minutes and allow
presentation
them to discuss in pair and write their answer on
 Think/Pair/
notebook about the question for another 2
Share
minutes and ask 3 participants to answer the
 Individual
question with a total of 5 minutes.
Reflection
 Display slide 17 and 18 respectively brief your
● Demonstrati
ons trainee on essential logistic data items used for
logistics decision.
 Display slide 19 (Activity 5.3 Self Reflection)
Tell all participants to write their answer on

21
 their notebook give those 2 minutes. Then give
chance for 3 participants to reflect their answer
about the question in slide 19 for a total of 3
minutes.
 Display slide 20 and 21 respectively. Explain
the use of stock recording form (Bincard). And
again tell them the data required to record on
Bincard.
 Display slide 22. Activity 5.4 (Demonstration)
before doing demonstration, give the fill out
Bincard form (30 printed Bincard form) to
trainees.
 Select one volunteer participant and inform the
participant; after listening and following the
trainer demonstration.
 and follow the participant demonstration how
she/he step by step explain the data in the
Bincard Column for a total of 15 minutes
 Display slide 23 and 24 respectively brief how
to reporting and ordering of Xpert MTB/RIF
(Ultra) and XDR Assay and what form used on
reporting and ordering.
 Display slide 25. Activity 5.5 (Demonstration)
before doing demonstration, give the fill out
IFRR form (30 printed IFRR form) to trainees.
 Select one volunteer participant and inform the
participant; after listening and following the
trainer demonstration.
 And follow the participant demonstration how
she/he step by step explain the data in the IFRR
Column for a total of 15 minutes.

22
  Give a chance to your trainee to ask questions
about the topic.

4 Equipment and 15  Display slide 26. (Activity 5.6) and let your
Supplies for trainees to think and for 2 minutes and allow
GeneXpert
MTB/RIF (Ultra) them to discus in pair and write their answer on
and XDR Assay notebook about the question for another 2
minutes and ask 3 participants to answer the
 Interactive
question for a total of 5 minutes.
presentation
 Display Slide 27-34 respectively brief the
 Think/Pair/
Share instrument, cartridges and Supplies for Xpert
MTB/RIF (ULTRA) & XDR Assay and
Additional supplies needed.
 Give a chance to your trainee to ask questions
about the topic.

5 Inventory 15  Display slide 35 – 37 respectively explain the

Management inventory management and assessing stock
 Interactive status within it.
presentation  Display slide 38. (Activity 5.7 Self-reflection)
 Individual Tell all participants to write their answer on
Reflection their notebook give those 2 minutes. Then give
chance for 3 participants to reflect their answer
about the question in slide 38 for a total of 3
minutes.
 Display slide 39 explain the stock
management/Physical inventory
 Display slide 40 brief the inventory control
(Min – Max)
 Give a chance to your trainee to ask questions
about the topic.

6 Storage and 13  Display slide 41. (Activity 5.8 Self- reflection)

Tell all participants to write their answer on
23
 Distribution their notebook give those 2 minutes. Then give
chance for 3 participants to reflect their answer
 Interactive
about the question in slide 41 for a total of 3
presentation
minutes.
 Individual
Reflection  Display slide 42- 47 respectively explain the
shelf life and expiry date regarding storage,
explain the proper storage for Xpert MTB/RIF
(Ultra) and XDR Assay, brief the distribution
and its cycle.
 Give a chance to your trainee to ask questions
about the topic.

7 Summary 5  Display slide 48-49 Summarize the Chapter by

stressing points provided in the chapter
summary of the participants manual. Give
chance for your trainee to ask question in case
they have unclear ideas.

Answer key
Activity 5.1 Individual reflection

Answer

1. Supply chain management (SCM) is the process of planning, implementing,

managing, and controlling all activities involved in sourcing, procurement, conversion,
and logistics management, with the aim of satisfying the end users as efficiently as
possible.
2. Logistics is basically a process of transporting goods (either raw material or finished
products) from one point to another point. So, the two major functions of logistics are
transportation and warehousing.
Activity 5.2 Think/Pair/Share

Answer

24
To make logistics decisions, a logistics manager needs three essential data items:

1. Stock on Hand: Quantities of usable Xpert MTB/RIF (Ultra) & XDR Testing
Cartridge and Supplies stock available at a particular point in time.
2. Consumption Data: The quantity of Xpert MTB/RIF (Ultra) & XDR Testing
Cartridge and Supplies used during the reporting period.
3. Losses/Adjustments:
 Losses are the quantities of Xpert MTB/RIF (Ultra) & XDR Testing Cartridge
and Supplies removed from your stock for anything other than in the provision
of services to patients or issuing to another facility (e.g., expiry, lost, theft, or
damage) and are recorded as negative (-) numbers.
 Adjustments are quantities of an Xpert MTB/RIF (Ultra) & XDR Testing
Cartridge and Supplies received from any source other than EPSS or
issued to anyone other than your health facility.
 An adjustment may also be a correction due to an error in mathematics.
 An adjustment may be a negative (-) or positive (+) number.
Activity 5.3 Individual Reflection

Answer

1. Bin Card (Stock Keeping Record): are used to account for products held in storage,
including their receipt and issue. In the IPLS re-supply decisions is recorded on the Bin
Card; data from these record are used in reporting, calculating reorder quantities and
for monitoring stock levels
2. The format used for reporting and ordering divided in to two internal facility (IFRR)
and to External (RRF)
 RRF (Report and requisition form): Report essential logistic data elements and
submitted to EPSS hubs by health facility and copy to RHB/ZHD/ WoHO
 IFRR (Internal facility and report re-supply form): Submitted to store by each testing
unit based on the internal reporting & refilling schedule (bi-weekly or monthly)
Activity 5.6 Think/Pair/Share

Answer

25
The instrument, cartridges and Supplies for Xpert MTB/RIF (ULTRA) & XDR
Assay:

 GeneXpert instrument, computer and barcode reader

 Kits of Xpert MTB/RIF test cartridges
 Kits of Xpert MTB/RIF (Ultra) & XDR test cartridges
 Kits of Xpert MTB/RIF calibration cartridges
 Additional Xpert MTB/RIF module for replacement

Additional supplies needed for Xpert MTB/RIF ((Ultra) & XDR) test but not
provided in kit

 Inverter with high capacity can save power at least for 2 hours
 Laboratory supplies (specimen containers, additional transfer pipettes, paper towels)
 Timer & Room Thermometer
 Personal protective equipment (lab coat, gloves)
 Printer
 Timer & Room Thermometer
 Disinfectant
Activity 5.7 Individual Reflection

Answer

A physical count of the products in the storeroom is done:

 To verify the stock level of pharmaceuticals in the store at the time of physical count
 To detect errors in drug management records
 To detect drug loss in the store
Activity 5.8 Individual Reflection

Answer

Pharmaceuticals have a shelf life which is specified by the manufacturer. When

pharmaceuticals reach the end of their shelf life, it is important that proper storage
procedures are followed, so that the shelf life is protected.

26
Always check the expiry dates before receiving, issuing or using, and do not use products
that have expired. The expiry date of the products should be indicated directly on the
product carton.

Module 8: Results Interpretation and Database Management

Chapter description: This chapter is designed for participants to understand the
interpretation of Xpert MTB/RIF (Ultra) & MTB/XDR assay results, reporting of patient
results and the management of GeneXpert database

Total time allocated: Time allocated: 2 hour (class room discussion) & 4 hour
(Laboratory demonstration)

Chapter Objective: By the end of this chapter, the participants will be able to:
 Analyze Xpert MTB/RIF (Ultra) & MTB/XDR assay results and GeneXpert
database

Enabling objectives: By the end of this chapter, the participants will be able to:
 Manipulate tests, & test information on GeneXpert Dx system,
 Demonstrate test- related information edition
 Analyze Xpert MTB/RIF (Ultra) assay results & real-time PCR curves
 Analyze Xpert MTB/XDR assay results
 Explain reasons to repeat the test
 Generate test report & data management
Summary of activities
SN Content Duration PowerPoint
Method of delivery
(min) slide number
27
 1 Visualizing the test results Presentation and 20 4-6
practical demonstration
2 Edit test-related information of the 5 7-8
Presentation and
test result
practical demonstration
3 Xpert MTB/RIF (Ultra) assay result Think/pair/share, 20 9-17
interpretation Presentation and
practical demonstration
4 Understanding trace results Think/pair/share and 10 18-22
Presentation
5 Reasons to repeat the test Presentation and brain 15 23-29
storm
6 Understanding the PCR Curves Think/pair/share, 10 30-35
presentation and
practical demonstration
7 Xpert MTB/XDR assay result Self-reflection, 25
interpretation presentation and
practical demonstration
8 Generate a result report Presentation and 10 53-57
practical demonstration
9 Summary & review question Interactive discussion 5 58

Resources needed:
 LCD, Laptop computer, Flip chart, Marker, GeneXpert instrument and pointer
 Participant manual

Learning activities
S No. Topic Time Teaching points
(min)
1 Visualizing the  Introduce the participants how to visualize Xpert MTB/RIF
test results result on GeneXpert Dx system
20  Show how to view a test result on GeneXpert Dx system on
practical demonstration. Then allow participants to practice for
15 minutes in each small group
2 Edit test-  Explain and demonstrate the participants how to edit the test
related results
information of  Tell the participants that they will be working in small groups
the test result in practicing editing test related information of the test result
5
 Fist demonstrate how to edit test related information, then
allow each participants in small group practicing in editing test
related information. Allow 15 minutes for each group to
practice this section
3 Xpert MTB/RIF 20  Tell the participants to read the question on activity 8.1 (Slide
(Ultra) assay 9), discuss with colleague beside them and reflect on the
result question to the class
28
 interpretation  Enable participants to participate on answering question & take
5 minute for answer & discussion
 Explain in detail each Xpert MTB/RIF (Ultra) assay results and
the interpretation of each results. Then randomly check if the
participants understand well
 Tell the participants that they have practical session where they
practice analyzing & interpreting the various Xpert MTB/RIF
(Ultra) assay results
 Demonstrate all potential Xpert MTB/RIF (Ultra) assay results
on practical session; take 20 minutes for each group on
practical demonstrations of this section
 Ask participants to roll-out confusion and finally summarize it.
4 Understanding  Tell the participants to read the question on activity 8.2 (Slide
trace results 18), discuss with colleague beside them and reflect on the
question to the class
 Enable participants to participate on answering question &
10
take 5 minute for answer & discussion
 Explain in detail what Xpert MTB/RIF (Ultra) assay trace
result mean and what points to consider when interpreting
trace results
5 Reasons to  Tell the participants to read the question on activity 8.2 (Slide
repeat the test 18), discuss with colleague beside them and reflect on the
question to the class
15  Enable participants to participate on answering question &
take 5 minute for answer & discussion
 Explain the reason why test is repeated
 Describe the possible test results that need test to be repeated
6 Understanding
the PCR  Explain what is PCR curves particularly baseline, log-linear,
10
Curves plateau, cycle threshold(Ct) and semi quantitative result
interpretation of Xpert MTB/RIF (Ultra) assay results
7 Xpert
MTB/XDR  Tell the participants to read the question on activity 8.4 (Slide
assay result 36) and reflect on the question for 5 minute
interpretation  Discuss in detail all the possible results in Xpert MTB/XDR
assay and there interpretation
25  Demonstrate all potential Xpert MTB/XRD assay results on
practical session; take 20 minutes for each group on practical
demonstrations of this section
 Ask participants to roll-out confusion and finally summarize
it.
6 Generate a  Introduce the participants how to generate a result report in
result report PDF format, print out and also how to copy on excel
10  Show how to generate a result report on practical
demonstration. Then allow each group of trainee to practice
how to generate result report for 10 minutes
7 Summary & 5
review  Summarize the presentation by discussing main points on slide
29
 question
58 and by asking questions on slide 59. Take responses and
reinforce.

Activity 8.1. Laboratory demonstration

Objective: Visualizing GeneXpert test results & editing test information
Instruction: Observe the facilitator while manipulating GeneXpert
software to perform below stated activists and you will demonstrate it
latter
Time: 4 hours (1hour for the facilitator to demonstrate, 3 hours for the
participant to demonstrate)
Activity: operate GeneXpert Software to:
1. View and edit test result information. (5Min)
2. analyze & interpret Xpert MTB/RIF (Ultra) assay (20Min)
3. analyze & interpret Xpert MTB/XDR assay(20min)
4. Display result in PDF format & print (5min)
5. Manage GeneXpert data (10min)

Discussion Questions and Answer

1. Activity 8.1: Discuss expected results that are obtained from Xpert MTB/RIF &
MTB/RIF Ultra assay?
Answer:
 MTB not detected: MTB target is not detected within the sample
 MTB detected; Rif resistance not detected : MTB target is present; Rif
resistant mutation is not detected
 MTB detected; Rif resistance not detected : MTB target is present; Rif
resistant mutation is also detected

 MTB detected; Rif resistance indeterminate: MTB target is present;

concentration of MTB was very low and Rif resistance could not be
determined

30
  MTB detected Trace ( *only for Xpert MTB/Rif Ultra assay): MTB target

is present; Rif resistance can’t be determined due to insufficient signal

detectio

2. Activity 8.2: When you get Trace results in Xpert Ulta, can you report the results
without repeating the test?
a. If yes, in what condition?
b. If no, in what condition?
Answer:
A, Yes, if the sample is from patients that are PLHIV & children or if the sample is
extra pulmonary
B, No, if the patients are not at risk of HIV

3. Activity 8.3: In what situation do we need to repeat GeneXpert MTB assays?

Answer:
We repeat the test when the results are: - Invalid, Error, No result & Rif
indeterminate
4. Activity 8.4: what is the added benefit of Xpert MTB/XDR assay that is different
from Xpert MTB/RIF (Ultra)?
Answer: it detects presence of mutations that confer resistance to various fist line
& second line drugs. These mutations include:
 katG, fabG1, oxyR-ahpC IGR and inhA genes for Isoniazid (INH)
resistance
 gyrA and gyrB genes for Fluoroquinolones (FLQ) resistance
 rrs and eis genes for Amikacin (AMK) resistance
 rrs and eis genes for Kanamycin (KAN) resistance
 rrs gene for Capreomycin (CAP) resistance
 inhA gene for Ethionamide (ETH) resistance

31
Additional resources or references:

 GLI Training Package on XPERT MTB/RIF.

http://www.stoptb.org/wg/gli/trainingpackages.asp
 Alagna R. Use of XpertMTB / RIF in resource limited settings Major challenges
on TB diagnosis. 2017;(November):1–49.
 gli. Planning for country transition to Xpert® MTB/RIF Ultra cartridges. 2017;
(April):1–44. Available from: http://www.who.int/tb/publications/2017/XpertUltra
 World Health Organization. Frequently asked questions about the WHO Technical
Expert Consultation findings on Xpert ® MTB / RIF Ultra. World Heal Organ
[Internet]. 2017;(March):5. Available from: https://www.who.int/tb/areas-of-
work/laboratory/diagnostics/FAQonUltraFinal-2018.pdf?ua=1
 World Health Organization (WHO). Operational handbook on tuberculosis
[Internet]. Module 3: Diagnosis Rapid diagnotics for tuberculosis diagnosis. 2020.
56 p. Available from:
https://apps.who.int/iris/bitstream/handle/10665/340256/9789240022614-eng.pdf
 GeneXpert Xpert MTB RIF User Manual.
https://www.manualslib.com/download/1197251/Genexpert-Xpert-Mtb-Rif.html

Module 9: Recording & Reporting

Duration: 1 hour 10 minutes
Primary Objective: At the end of this chapter, the participants will be able to perform
correct recording and reporting of Xpert MTB/RIF (Ultra) and Xpert MTB/XDR results.
Enabling objectives: At the end of this chapter, participants will be able to:
 To describe essential elements of recording and reporting Xpert MTB/RIF(Ultra)
and Xpert MTB/XDR Results
 To practice accurate and complete recording of Xpert TB result
 To write recording Xpert MTB/RIF (Ultra) and MTB/XDR results correctly in the
laboratory register
 To explain the benefits of recording and reporting accurate and complete records
 To practice accurate and complete reporting of Xpert TB result

32
 Summary of Activity

S/No Activities Method of delivery Time Slide Number

think, pair/share & Interactive
1 Laboratory Record Keeping presentation
12 min. 4-5
Laboratory request & report form
2 Interactive Presentation & 20 min. 6-13
content group discussion
Laboratory Register
3 Interactive Presentation & 15 min. 14-19
group discussion

4 Accurate & complete recording and Interactive Presentation & 10 min 20-23
reporting group discussion

5 Reporting key Indicators for Xpert Interactive Presentation 10 min. 17-24

MTB/RIF testing

6 Summary Interactive Presentation 5 min 25-26

Advance preparation

 Prepare actual request and report format

 Prepare actual registration book format
 Prepare red pen for positive result written

Learning Activity

# Content Time Activities

(Minute)

1 Laboratory 12 min  Introduce yourself to the participants, give chance for the

Record trainees to tell their expectation in this training

Keeping  Show slide 2 the chapter outline of the presentation

 think,  Review the enabling objectives by displaying slide 3

pair/share  Display slide 4 Activity 9.1 think/pair /share. Ask the
 Interactive participants to Pair with a person sited next you and allow
presentation them to discus in pair and write their answer on notebook
about the question for another 4 minute. Ask randomly 3
33
 participants to answer the question. 6 minute given for
answering for all participants
 Display slide 5 and describe the functions of record keeping
 Ask participants if they have questions on this related topic

2 Laboratory 20 min  Display slide 6-12 respectively. Explain the participants the
request & contents of laboratory request & report form (Patient
identification and personal information, TB disease type and
report form treatment history, request for testing at TB laboratory and
content Laboratory information) and how to fill the report form
 Display slide 13 (activity 9.2 group discussion) and order
 Interactive
your trainees to form five groups which have 5-6 participants
Presentatio
then give 5 minutes for discussion and select randomly 2
n
groups to answer the questions. 5 minutes given for selected
 Group
groups. Ask the remaining group unaddressed questions by
discussion
the presenter groups
3 Laboratory 15 min.  Display slide 14 (activity 9.3 group discussion) and order
Register your trainees to form five groups which have 5-6 participants
 Interactive then give 1 minutes for discussion and ask each group to
Presentatio answer the questions. 4 minutes given for answering
n  Display slide 15-19 respectively. Explain the participants the
 Group contents of laboratory registration book and how to fill the
discussion report form
4 Accurate & 10 min  Display slide 20 (activity 9.4 group discussion) and order
complete your trainees to form five groups which have 5-6 participants
recording and then give 5 minutes for discussion and select randomly 2
reporting groups to answer the questions. 5 minutes given for selected
 Interactive groups. Ask the remaining group unaddressed questions by
Presentatio the presenter groups
n  Display slide 21-23 respectively, and explain the importance
 Group of accurate and complete recording and reporting and
discussion consequences of inaccurate and incomplete recording and
reporting

34
5 Reporting key 10 min.  Display slide 24-25 respectively, and explain the GeneXpert

Indicators for performance formats and its contents. These slides focus on

Xpert reporting results and should customize to reflect the

MTB/RIF country’s recording and reporting practices

testing  Ask participants if they have questions on this related topic

6 Summary 5 min  Display slide 26 respectively, Summarize the Chapter by

stressing points provided in the chapter summary of the
participant’s manual. Give chance for your trainee to ask
question in case they have unclear ideas.

Answer key
Activity9.1. Think/pair/share
Laboratory request & report form contents
I. Patient identification and personal information (full name and address, Age & sex,
Phone number, Contact name and address)
II. TB disease type and treatment history ( site of infection such as pulmonary Tb and
Extra Pulmonary TB, patient registration group such as new, relapse, lost to follow-up
and after failure to treatment)
III. Request for testing at TB laboratory (Diagnosis such as Presumptive TB or
Presumptive drug resistance TB, follow-up, Specimen type such as sputum or other
extra fluid, Specimen quality such as bloody, saliva, purulent, semi purulent etc…,
requested tests such as AFB, MTB/RIF, MTB/XDR, culture etc…, requested clinician
such as name, sign and date of request)
IV. Laboratory information (sample Collected by, sign, collection date and Sample ID
etc……) Result (AFB, MTB/RIF (Ultra), culture, LF-LAM & MTB/XDR results)
Laboratory registration book contents
• Date specimen received/ collected
• Laboratory Serial Number
• Patient's information (name, sex, age, address and register number)
• Name and address of contact person

35
 • Name of referring unit/facility
• Medical registration number
• HIV status
• Patient registration group
• Presumptive TB /MDR
• Reason for examination (e.g., diagnosis or follow-up)
• Specimen Type (Bloody, Saliva, Mucoid, purulent etc…)
• Results
• TAT
The benefits of accurate and complete records are
 Avoid clerical errors
 Avoid unnecessarily treatment
Activity9.3. Group discussion
Answer:
 Lab serial number, specimen collection date, date reported, specimen type,
specimen quality, Name of patient, address, age, sex, name of contact persons and
address, name of referring Hfs/unit, presumptive TB/DR-TB, MRN, HIV status,
CD4, patient registration group, reason for examination Xpert result, LF-LAM
result, AFB result, TAT and Initial
Activity9.4. Group discussion
Answer:
 False-negatives are the results that were reported as negative were truly positive
 False-positives are the results that were reported as positive were truly negative
 Patients are treated unnecessarily or treatment may continue longer than necessary
What are the key indicators of Xpert MTB/RIF testing?
Refer to page 10-12 from participant manual the key indicators of Xpert MTB/RIF testing

Additional resources or references:

36
 Definitions and reporting framework for tuberculosis – 2013 revision. Geneva, World
Health Organization. 2013. (WHO/HTM/TB/2013.2).
http://www.who.int/tb/publications/definitions

37