background signal).

Ct levels are inversely proportional to the amount of target

®
Truenat nucleic acid in the sample (i.e. the lower the Ct level the greater is the amount
of target nucleic acid in the sample). In the case of negative samples,
amplification does not occur and a horizontal amplification curve is displayed
10. SPECIMEN PREPARATION FOR EXTRACTION WITH Trueprep® AUTO /
AUTO v2
Truenat® HCV requires purified nucleic acids from whole blood
HCV on the screen during the test run. At the end of the test run, HCV “DETECTED”
or “NOT DETECTED” result is displayed, and in positive cases, Ct values and
(venous)/plasma collected in EDTA anticoagulant or serum specimen that are
extracted using the Trueprep® AUTO/AUTO v2 Universal Cartridge Based
Chip-based Real Time PCR Test for Hepatitis C Virus International Units (IU) per milliliter (IU/ml) is also displayed on the screen. Sample Prep Device and Trueprep® AUTO/AUTO v2 Universal Cartridge
Based on the detection of the internal positive control (IPC), the validity of the Based Sample Prep Kit. Sample must be pre-treated using Trueprep® AUTO
1. INTENDED USE
test run is also displayed. The IPC is a full process control that undergoes all Universal Sample Pre-treatment Pack. Transfer 250µl of whole blood
Truenat® HCV (REF 601180005 / 601180020 / 601180025 / 601180050 /
the processes the specimen undergoes – from extraction to amplification (venous) or 500µl of plasma/serum specimen using the graduated transfer
601180100 / 601180200) is an automated point-of-care or near patient Chip-
thereby validating the test run from sample to result. Absence of or shift of IPC pipette provided into the lysis buffer tube provided and mix well (refer to the
based Real Time Reverse Transcription Polymerase Chain Reaction (RT-
Ct beyond a pre-set range in case of negative samples invalidates the test run. package insert of Trueprep® AUTO Universal Sample Pre-treatment Pack for
PCR) test for the quantitative detection of Hepatitis C virus (HCV) RNA in
While IPC will co-amplify in most positive cases also, in some specimen further details).
human plasma, serum and whole blood (venous) samples. Truenat® HCV aids
having a high target load, the IPC may not amplify, however the test run is still Sample Storage and Transportation:
in the diagnosis and confirmation of HCV infection (in conjunction with HCV
considered valid. The results can be printed using the Truelab® micro PCR To ensure the integrity of collected samples, it is ideal to process them
antibody test) and in estimation of viral load. It is not intended as a blood donor
Printer or transferred to the lab computer/or any remote computer via Wifi immediately. However, if immediate processing is not feasible, it is
screening test. Truenat® HCV runs on the Truelab® Real Time Quantitative
network or 4G/3G/GPRS network. Upto 20,000 results in Truelab® Uno recommended to adhere to the following sample storage conditions:
micro PCR Analyzer. Truenat® HCV is a single-use in vitro diagnostics test
Dx/Duo/Quattro can be stored on the analyzer for future recall and reference. Stability period
meant for professional use in near-patient, laboratory or any healthcare Stability temperature
settings, by healthcare professionals or any user appropriately trained by a Blood Serum Plasma
4. TARGET SELECTION -80°C 07 weeks 07 weeks 07 weeks
representative of Molbio Diagnostics. The target sequence for this assay is the 3' UTR region of the HCV genome.
-20°C 07 weeks 07 weeks 07 weeks
2. INTRODUCTION 5. CONTENTS OF THE Truenat® HCV KIT 4°C 04 hours 08 hours 08 hours
The positive-sense single-stranded ribonucleic acid (RNA) virus, Hepatitis C A. Individually sealed pouches 35°C 04 hours 04 hours 04 hours
Virus (HCV), belongs to the genus Hepacivirus, a member of the family B. Package insert Note: These recommendations are based on internal laboratory findings.
Flaviviridae. The core genetic material (RNA) is surrounded by an icosahedral Each individually sealed pouch contains: Pre-treated Sample Storage and Transportation:
protective shell of protein and further encased in a lipid envelope of cellular 1. Truenat® HCV micro PCR chip (1 No.) Sample pre-treatment decontaminates the specimen and makes it ready for
origin. The Hepatitis C Virus is classified into six major genotypes (1-6) with 2. Microtube with freeze dried RT-PCR reagents (1 No.) storage / transportation / extraction. The specimen in this form is stable for:
several subtypes within each genotype. It is the cause of Hepatitis C and some 3. DNase and RNase free pipette tip (1 No.)
cancer lymphomas in humans. Unlike Hepatitis A and B, there is no vaccine as Stability period
4. Desiccant pouch (1 No.) Stability temperature
yet that protects against contracting Hepatitis C. As per WHO reports, Blood Serum Plasma
130–150 million people globally have chronic hepatitis C infection. For a small Pack sizes of Truenat® HCV KIT 2°C to 8°C 09 days 03 days 03 days
percentage of people, Hepatitis C is a short-term illness but for an estimated Room temperature (22°C±2°C) 02 days 01 day 01 day
601180005 601180020 601180025 601180050 601180100 601180200 30°C 01 days 04 hours 04 hours
70%–85% of people who become infected with Hepatitis C, it becomes a long-
term, chronic infection. Approximately half a million people die each year from 20T 25T 100T 200T
Nucleic acid extraction: Use entire content from the lysis buffer tube
complications and liver diseases related to Hepatitis C. Globally genotype 1 ® containing specimen for further procedure with the Trueprep® AUTO/AUTO
(specifically subtypes 1a and 1b) is the most prevalent, causing almost half of 6. CONTENTS OF THE Trueprep AUTO Universal Sample Pre-treatment
v2 Universal Cartridge Based Sample Prep Device and Trueprep®
all HCV infections. Nucleic acid amplification tests (NAAT) for the detection of Pack
AUTO/AUTO v2 Universal Cartridge Based Sample Prep Kit (refer to the user
HCV RNA is recommended to be performed directly following a positive HCV A. Lysis buffer.
manual of Trueprep® AUTO/AUTO v2 Universal Cartridge Based Sample
serological test to establish the diagnosis of chronic HCV infection. This is B. Disposable transfer pipette (graduated).
Prep Device and the package insert of Trueprep® AUTO/AUTO v2 Universal
because a portion of the infected population spontaneously clears the C. Package insert.
Cartridge Based Sample Prep Kit for details). Dispose off lysis buffer tube and
infection by a strong immune response and without any treatment. They will Pack sizes of Trueprep® AUTO Universal Sample Pre-treatment Pack
transfer pipette after use, as per the section on “Disposal and Destruction”
continue to test positive for anti-HCV antibodies despite clearing the infection. (Section 18).
Quantitative NAATs are also important in order to make clinical decisions on 60205AB05 60205AB20 60205AB25 60205AB50 60205AB100 60205AB200
starting treatment for HCV infection. Approximately half of all patients who 20T 25T 100T 200T
11. SAFETY PRECAUTIONS
undergo treatment with anti-viral medication for 24-48 weeks are cleared of 1. For in vitro diagnostic use only.
the infection. Newer therapy that clears HCV infection in 12 weeks has 7. CONTENTS OF THE Trueprep® AUTO/AUTO v2 Universal Cartridge +30°C
2. Bring all reagents and specimen to room temperature (20-30°C) before
recently been approved. Successful treatment decreases the risk of Based Sample Prep Kit +2°C
use.
hepatocellular carcinoma by almost 75%. Success of treatment is indicated by A. The reagent pack contains the following reagents
3. Do not use kit beyond expiry date.
sustained virologic response (SVR), defined as undetectable HCV RNA in the No. Contents Purpose 4. Carefully read the user manuals, package inserts and Material Safety
patient's blood 24 weeks after the end of treatment. NAAT tests are therefore Data Sheets (MSDS) of all the components of the Truenat® point-of-care
crucial for diagnosis, treatment initiation and treatment monitoring of HCV. 1. Wash Buffer A To wash inhibitors from the sample
real time PCR system before use.
Unfortunately, the full benefits of diagnosis and treatment guidance using 2. Wash Buffer B To wash inhibitors from the sample 5. Good laboratory practices are recommended to avoid contamination of
molecular tests have not yet reached the majority of HCV–infected patients specimens or reagents.
who live in countries with limited resources because of the costs and technical 3. Elution Buffer To elute nucleic acids
6. All materials of human origin should be handled as though potentially
constraints. Molecular/NAAT tests have so far been restricted to centralized 4. Priming Waste To purge residual liquid from tubing infectious.
reference laboratories as they require skilled manpower and elaborate 7. Do not pipette any material by mouth.
infrastructure. Also the turnaround time for results could take a few days . B. The cartridge pack contains the following:
8. Do not eat, drink, smoke, apply cosmetics or handle contact lenses in the
The Truenat® point-of-care real time PCR system enables area where testing is done.
decentralization and near patient diagnosis and viral load No. Contents Purpose
9. Use protective clothing and wear disposable gloves when handling
monitoring of HCV by making real time PCR technology 1. Cartridge Cartridges containing immobilized internal control samples and while performing sample extraction.
rapid, simple, robust and user friendly, thereby offering (IPC) for extraction
10. Do not substitute assay components / reagents with any other
“sample to result” capability even at resource limited components / reagents.
settings. This is achieved through a combination of 2. Elute collection tube Capped tubes for collection and storage of
(ECT) extracted nucleic acids 11. Each single-use Truenat® chip is used to process one test. Do not reuse
lightweight, portable, mains / battery operated Truelab® Real Time chip.
Quantitative micro PCR Analyzer and Trueprep® AUTO/AUTO v2 Universal 3. Elute collection tube To label Elute Collection Tube (ECT)
Cartridge Based Sample Prep Device and room temperature stable Truenat® (ECT) label 12. PROCEDURAL PRECAUTIONS
micro PCR chips and Trueprep® AUTO/AUTO v2 Universal Cartridge Based 1. Check all packages before using the kit. Damage to the packaging does
4. Disposable transfer To pierce the seal of elute chamber and to transfer
Sample Prep Kit so that even the peripheral laboratories with minimal pipette extracted nucleic acids from elute chamber of cartridge not prevent the contents of the kit from being used. However, if the outer
infrastructure and minimally trained technician can easily perform these tests into the Elute Collection Tube (ECT) packaging is damaged the user must confirm that individual components
routinely in their facilities and report PCR results in less than an hour. of the kit are intact before using them.
Moreover, with these devices PCR testing can also be initiated in the field C. Disposable transfer pipettes (graduated) - 3 mL
2. Do not perform the test in the presence of reactive vapours (e.g. from
level, on site. D. Reagent reset card-1 No.
sodium hypochlorite, acids, alkalis or aldehydes) or dust.
Truenat® HCV is a disposable, room temperature stable, Chip-based Real E. Package insert
3. While retrieving the Truenat® HCV chip, microtube and the DNase and
Time PCR test with dried MgCl2 in reaction well and freeze dried RT-PCR Pack sizes of Trueprep® AUTO Universal Cartridge Based Sample Prep Kit RNase free pipette tip from the pouch, ensure that neither bare hands nor
reagents in microtube for performing Real Time RT-PCR test for detection of gloves that have been used for previous tests run are used.
HCV and runs on the Truelab® Real Time Quantitative micro PCR Analyzer. All REF 60203AR05 60203AR25 60203AR50 60203AR100 60203AR200 4. Ensure that the colour of the desiccant pouch is orange after opening a
components of Truenat® pouch are nuclease-free. It requires only six (6) µL of 5T 25T 50T 100T 200T sealed Truenat® chip pouch. If the colour of the desiccant pouch changes
purified RNA to be added to the reaction well for the analysis. The intelligent from orange to white due to the absorption of moisture, do not use the
chip also carries test and batch related information. The Truenat® HCV chip Pack sizes of Trueprep® AUTO v2 Universal Cartridge Based Sample Prep
contents of the Truenat® chip pouch.
also stores information of used chips to prevent any accidental re-use of the Kit
chip. 13. PROCEDURAL LIMITATIONS
60207AR05 60207AR25 60207AR50 60207AR100 60207AR200
NOTE : Truelab®/ Truenat® / Trueprep® / Truepet® are all trademarks of 1. Optimal performance of this test requires appropriate specimen collection,
Molbio Diagnostics Private Limited. 25T 100T 200T
handling, storage and transport to the test site.
The Truelab® Real Time micro PCR Analyzer is protected by the following 2. Though very rare, mutations within the highly conserved regions of the
patents and patents granted: IN 2313/CHE/2007 (Patent No. 281573), 8. STORAGE, HANDLING AND STABILITY
+30°C target genome where the Truenat® assay primers and/or probe bind may
WO2009/047804 and corresponding claims of any foreign counterpart(s) 1. Truenat® HCV test is stable for two (2) years from the date of manufacture
+2°C
result in the under-quantitation of or a failure to detect the presence of the
thereof. if stored between 2-30°C. It is also stable for one (1) month at
concerned pathogen.
The Truenat® micro PCR chip is protected by the following patents and temperatures up to 45°C. Avoid exposure to light or elevated
3. The instruments and assay procedures are designed to minimize the risk
patents pending: IN 2312/CHE/2007, WO 2009/047805 and temperatures (above recommended levels). Do not freeze.
+40°C of contamination by PCR amplification products. However, it is essential
corresponding claims of any foreign counterpart(s) thereof. 2. Trueprep® AUTO Universal Sample Pre-treatment Pack is stable for two
+2°C
to follow good laboratory practices and ensure careful adherence to the
(2) years from the date of manufacture if stored between 2-40°C. It is also
procedures specified in this package insert for avoiding nucleic acid
3. PRINCIPLE OF THE TEST stable for one (1) month at temperatures upto 45°C. Do not freeze.
+40°C contamination from previous amplifications, positive controls or
Truenat® HCV works on the principle of Real Time Reverse Transcription 3. Trueprep® AUTO/AUTO v2 Universal Cartridge Based Sample Prep Kit is
+2°C
specimens.
Polymerase Chain Reaction (RT-PCR) based on Taqman chemistry. The stable for two (2) years from the date of manufacture if stored between
4. A specimen for which the Truenat® assay reports “Not Detected” cannot
patient sample (whole blood / plasma / serum) is first pre-treated using the 2°C to 40°C. It is also stable for one (1) month at temperatures up to 45°C.
be concluded to be negative for the concerned pathogen. As with any
Trueprep® AUTO Universal Sample Pre-treatment Pack. The RNA from the Avoid exposure to sunlight.
diagnostic test, results from the Truenat® assay should be interpreted in
pre-treated sample is then extracted using Trueprep® AUTO/AUTO v2 4. Do not open the pouch until ready to test. Make sure to start the test
the context of other clinical and laboratory findings.
Universal Cartridge Based Sample Prep Device and Trueprep® AUTO/AUTO promptly after 30-60 seconds of adding the elute to the microtube.
v2 Universal Cartridge Based Sample Prep Kit. The cartridge from the 5. Do not use the pouch if torn.
14. CLEANING AND DECONTAMINATION
Trueprep® AUTO/AUTO v2 Universal Cartridge Based Sample Prep Kit 6. Do not use pouches that have passed the expiration date.
1. Spills of potentially infectious material should be cleaned up immediately
contains pre-loaded Internal Positive Control (IPC), it is a synthetic plasmid with absorbent paper tissue and the contaminated area should be
construct provided in a stable formulation preloaded into Cartridges which is 9. MATERIALS REQUIRED BUT NOT PROVIDED WITH THE KIT
decontaminated with disinfectants such as 0.5% freshly prepared sodium
co-extracted along with sample nucleic acids, thereby validating the process Truelab® Real Time micro PCR Workstation (REF 623010001 / 633010001 /
hypochlorite [10 times dilution of 5% sodium hypochlorite (household
from extraction to PCR run. The RNA extract is analyzed using the Truenat® 643010001 / 653010001) consisting of
bleach)] before continuing work.
HCV Chip-based Real Time Reverse Transcription Polymerase Chain 1. Trueprep® AUTO/AUTO v2 Universal Cartridge Based Sample Prep
2. Sodium hypochlorite should not be used on an acid-containing spill unless
Reaction (RT-PCR) test and the Truelab® Real Time Quantitative micro PCR Device (REF 603041001 / 603042001).
the spill-area is wiped dry first. Materials used to clean spills, including
Analyzer. Truenat® HCV chip is placed on the chip tray of the Truelab® Real 2. Truelab® Uno Dx / Duo / Quattro Real Time Quantitative micro PCR
gloves, should be disposed off as potentially bio-hazardous waste e.g. in a
Time Quantitative micro PCR Analyzer. Six (6) µL of the purified RNA is then Analyzer (REF 603021001 / 603022001 / 603023001).
bio-hazard waste container.
dispensed using the provided calibrated micropipette and tip into the 3. Truelab® micro PCR Printer (REF 603050001).
microtube containing freeze dried RT-PCR reagents and allowed to stand for 4. Truepet® SPA fixed volume precision micropipette - 6 µl (REF
15. TEST PROCEDURE
30-60 seconds to get a clear solution. No mixing by tapping, shaking or by 604070006).
(Please also refer the Truelab® Real Time Quantitative micro PCR Analyzer
reverse pipetting should be done. Six (6) µL of this clear solution is then 5. Truelab® Microtube Stand (REF 603070001).
user manual).
pipetted out using the same pipette and tip and dispensed into the reaction well Also required additionally are: Trueprep® AUTO Universal Sample Pre-
1. Switch on theTruelab® analyzer.
of the Truenat® HCV chip and the test is inserted in the Truelab® Real Time treatment Pack (REF 60205AB05 / 60205AB20 / 60205AB25 / 60205AB50 /
2. Select Username and enter password.
Quantitative micro PCR Analyzer where the RNA is first converted into 60205AB100 / 60205AB200), Trueprep® AUTO Universal Cartridge Based
3. For Truelab® Uno Dx, select the test profile for “HCV” to be run from the
complementary DNA (cDNA) by the RT enzyme and further thermal cycling Sample Prep Kit (REF 60203AR05 / 60203AR25 / 60203AR50 / 60203AR100 /
profiles screen on the analyzer screen. For Truelab® Duo/Quattro, select
takes place. A positive amplification causes the dual labeled fluorescent probe 60203AR200) or Trueprep® AUTO v2 Universal Cartridge Based Sample Prep
the bay (I/II) for Duo and (I/II/III/IV) for Quattro from the status screen to
in the Truenat® HCV chip to release the fluorophores in an exponential manner Kit (REF 60207AR05 / 60207AR25 / 60207AR50 / 60207AR100 /
view the profiles screen. Select the test profile for “HCV” to be run from the
which is then captured by the built-in opto-electronic sensor and displayed as 60207AR200), Truenat® Positive Control Kit - Panel II (REF 801020008),
profiles screen, on the analyzer screen.
amplification curve on the analyzer screen, on a real time basis during the test powder free disposable gloves, waste disposal container with lid and sodium
4. Enter the patient details as prompted in the Truelab® analyzer screen.
run. The Cycle threshold (Ct) is defined as the number of amplification cycles hypochlorite.
5. Press start reaction.
required for the fluorescent signal to cross the threshold (i.e. exceed the 6. For Truelab® Uno Dx, press the eject button to open the chip tray. For
 Truelab® Duo/Quattro, the chip tray opens automatically on tapping the Linearity for different HCV Genotypes: Interference:
“Start Reaction” button. Genotype 1-6 for HCV were made in plasma, blood and serum and the nucleic a) Effect of endogenous substances: The interference of endogenous
7. Open a pouch of Truenat® HCV and retrieve the micro PCR chip, acids were extracted on Trueprep® AUTO Universal Cartridge Based Sample substances on the performance of Truenat® HCV was performed by spiking
microtube and DNase & RNase free pipette tip. Do not open the pouch Prep Device followed by PCR on Truelab® Real Time Quantitative micro PCR the endogenous substances at abnormally high levels to 5 different negative
until ready to test. Analyzer. plasma as well as 5 different plasma spiked with HCV sample concentration at
8. Place the Truenat® HCV chip on the chip tray without touching the white Sample type Dilution series Linearity 3 x LoD. Further both the HCV negative and positive samples were subjected
reaction well. The reaction well should be facing up and away from the Plasma 1.76E+08 IU/mL to 7 orders of magnitude to sample prep on Trueprep® AUTO Universal Cartridge Based Sample Prep
analyzer. Gently place the chip on the chip tray by aligning it in the slot 1.76E+02 IU/mL Device and PCR was performed by Truenat® HCV test. The endogenous
provided. Genotype 1 Blood 2.35E+08 IU/mL to 6 orders of magnitude substances tested were:
9. Place the microtube containing freeze dried RT-PCR reagents in the 2.35E+03 IU/mL A. Albumin (9.6g/dL)
microtube stand provided along with the Truelab® Real Time micro PCR Serum 1.76E+08 IU/mL to 6 orders of magnitude B. Triglycerides (3186mg/dL)
workstation after ensuring that white pellet of freeze dried RT-PCR 1.76E+03 IU/mL C. Bilirubin (62 mg/dL)
reagents remains at the bottom of the microtube. Remove the microtube Genotype 2 Plasma 2.48E+08 IU/mL to 7 orders of magnitude D. Hemoglobin (472mg/dL)
cap and dispose it off as per the section on “Disposal and Destruction” 2.48E+02 IU/mL The performance of the Truenat® HCV assay was not affected by the
(Section 18). Using the filter barrier tip provided in the pouch, pipette out Blood 2.00E+08 IU/mL to 6 orders of magnitude endogenous substances mentioned under the stated experimental
six (6) µL of the purified RNA from the elute collection tube into the 2.00E+03 IU/mL conditions. The observed variation with regard to the HCV viral load was
microtube. Allow it to stand for 30-60 seconds to get a clear Serum 2.48E+08 IU/mL to 7 orders of magnitude within the accepted range of ≤0.5 log IU/mL in comparison to the positive
solution. Do not mix it by tapping, shaking or by reverse pipetting. 2.48E+02 IU/mL control samples.
Using the same filter barrier tip, pipette out six (6) µL of this clear solution Genotype 3 Plasma 2.10E+08 IU/mL to 7 orders of magnitude b) Effect of added autoimmune disease markers: 3x LoD HCV sample
and dispense into the centre of the white reaction well of the Truenat® 2.10E+02 IU/mL was spiked into plasma samples containing the autoimmune disease markers
HCV chip. Take care not to scratch the internal well surface and not to spill Blood 1.80E+08 IU/mL to 6 orders of magnitude for systemic lupus erythematosus, rheumatoid factor and anti-nuclear
elute on the outside of the well. Dispose off the microtip as per the section 1.80E+03 IU/mL antibody and the performance of Truenat® HCV assay tested. Under the
on “Disposal and Destruction”(Section 18). Serum 2.10E+08 IU/mL to 7 orders of magnitude experimental conditions the performance of Truenat® HCV assay was not
10. For Truelab® Uno Dx, slide the chip tray containing the Truenat® HCV 2.10E+02 IU/mL affected. The observed variation with regard to the HCV viral load was within
Genotype 4 Plasma 3.30E+08 IU/mL to 7 orders of magnitude
Chip-based Real Time PCR test loaded with the sample into the Truelab® the accepted range of ≤0.5 log IU/mL in comparison to the positive control
3.30E+02 IU/mL
analyzer. Press “YES” on the “Please Load Sample” prompt. For samples.
Blood 5.00E+08 IU/mL to 6 orders of magnitude
Truelab® Duo/Quattro, select “YES” at the “Please Load Sample” 5.00E+03 IU/mL
c) Effect of interfering drugs: The interference of exogenous substances
prompt. Chip tray will close automatically and the reaction will start. Serum 3.30E+08 IU/mL to 7 orders of magnitude (respective drugs) on the performance of Truenat® HCV was performed by
Make sure to start the test promptly after 30-60 seconds of adding 3.30E+02 IU/mL spiking the exogenous substances >3 times the peak plasma levels (3 times C
the elute to the microtube. Genotype 5 Plasma 5.50E+08 IU/mL to 7 orders of magnitude max concentration) to 5 different negative plasma as well as 5 different
11. Read the result from the screen. 5.50E+02 IU/mL plasma spiked with HCV RNA concentration at 3 x LoD. Further both the HCV
12. After the reaction is completed, for Truelab® Uno Dx, push the eject Blood 7.00E+08 IU/mL to 6 orders of magnitude negative and positive samples were subjected to sample prep on Trueprep®
button to eject the chip tray. For Truelab® Duo/Quattro, tap the 7.00E+03 IU/mL AUTO Universal Cartridge Based Sample Prep Device and PCR was
“Open/Close Tray” button to eject the chip tray. Serum 5.50E+08 IU/mL to 7 orders of magnitude performed by Truenat® HCV test.
13. Take out the Truenat® HCV micro PCR chip at end of the test and dispose 5.50E+02 IU/mL
it off as per the section on “Disposal and Destruction” (Section 18). Genotype 6 Plasma 2.40E+08 IU/mL to 7 orders of magnitude List of drugs and concentration used List of drugs and concentration used
2.40E+02 IU/mL
14. Turn on Truelab® micro PCR printer and select print on the screen for Stavudine (2.05µg/mL) Ritonavir(44.4 µg/mL)
Blood 3.50E+08 IU/mL to 6 orders of magnitude Zidovudine (6.87µg/mL) Efavirenz (12.21µg/mL)
printing out hard copy of the results. Test results are automatically stored 3.50E+03 IU/mL Ribavirin (11.04 µg/mL) Nevirapine (17.22µg/mL)
and can be retrieved any time later. (Refer to Truelab® analyzer manual). Serum 2.40E+08 IU/mL to 7 orders of magnitude Ganciclovir (27µg/mL) Valacyclovir HCL (24.06µg/mL)
15. Switch off the Truelab® analyzer. 2.40E+02 IU/mL Abacavir sulfate (12.9µg/mL) Lamivudine(35.52 µg/mL)
Indinavir sulfate (35.52 µg/mL) Entecavir (4.2ng/mL)
16. RESULTS & INTERPRETATIONS Limit of detection: Saquinavir mesylate (15.62µg/mL) Ciprofloxacin(2.4 µg/mL)
Two amplification curves are displayed on the Truelab® analyzer screen to LoD was estimated for plasma, blood and serum using NIBSC 6th WHO Nelfinavir mesylate (12µg/mL) Sofosbuvir (0.71µg/mL)
indicate the progress of the test. Both the target and the internal positive Clarithromycin (30µg/mL) Daclatasvir( 1.5µg/mL)
International Standard for Hepatitis C virus RNA with NIBSC code: 18/184 on Azithromycin (15.62µg/mL) Interferon Alpha 2B (820 IU/mL)
control (IPC) curves will take a steep, exponential path when the fluorescence two different lots of reagents. Tenofovir (0.98µg/mL) Acyclovir (62.1µg/mL)
crosses the threshold value in case of positive samples. The Cycle threshold Limit of detection for plasma and serum: A dilution series ranging from Enfuvirdite (13.8µg/mL) Fosamprenavir( 6.08 µg/mL)
(Ct) will depend on the number of target nucleic acids in the sample. The 8000, 4000, 2000, 1000, 500, 250, 125, 62.5 and 0 IU/mL of the NIBSC Valganciclovir HCL (20.19µg/mL) Lopinavir( 42µg/mL)
target curve will remain horizontal throughout the test duration and the IPC standard was made in negative plasma and serum matrix. Each dilution was
curve will take an exponential path in case of negative samples. In case the extracted (3x8=24 runs) over a period of 3 different days using 2 lots of Determination of carry-over contamination:
IPC curve remains horizontal in a negative sample, the test is considered as reagents. The number of runs accounted for 48 replicates for each dilution To determine whether the Truenat® HCV Chip-based Real Time PCR test
invalid. At the end of the test run, the results screen will display “DETECTED” using both the lots (lot 1 & lot 2) comprising of sample prep on Trueprep® showed any signs of carryover of PCR products between runs, alternate runs
for positive result or “NOT DETECTED” for Negative result. The result screen AUTO and PCR using Truenat® HCV test. The data obtained was analyzed by of positive high titre samples and negative samples were run on Truelab®. For
would also display the Ct value and the IU/mL for positive specimen. The probit analysis. The LoD for the plasma was determined to be 204.71 IU/mL this study blood was utilized as the sample type. Blood was spiked with a high
result screen also displays the validity of the test run as “VALID” or “INVALID”. with 95%CI of 178.26 to 247.84 IU/mL and the LoD for serum was determined positive >1.00E+06 IU/mL armored RNA of Hepatitis C virus genotype 2b from
Invalid samples have to be repeated with fresh specimen from the sample to be 260.42 IU/mL with 95%CI of 229.68 to 307 IU/mL. Asuragen. One lot of reagents was used for this study. This was tested on a
preparation stage. While IPC will co-amplify in most positive cases also, in Limit of detection for blood: A dilution series ranging from 3000, 2500, single Trueprep® AUTO Universal Cartridge Based Sample Prep Device and a
some specimen having a high target load, the IPC may not amplify, however 2000, 1500, 1000, 500, 250 and 0 IU/mL of the NIBSC standard was made in single Truelab® device by 2 users for 3 days. Alternate positive and negative
the test run is still considered valid. negative blood matrix. Each dilution was extracted (3x8=24 runs) over a samples were subjected to sample prep followed by PCR by user 1 and user 2
period of 3 different days using 2 lots of reagents. The number of runs over a span of 6 days. Devices were placed adjacent to each other to mimic a
17. QUALITY CONTROL PROCEDURES accounted for 48 replicates for each dilution using both the lots (lot 1 & lot 2) typical use case scenario. User 1 performed the runs for the first 3 days
To ensure that the Truelab® Real Time micro PCR Analyzer is working comprising of sample prep on Trueprep® AUTO Universal Cartridge Based followed by user 2 for the next 3 days. Each user ran 20 negatives and 20
accurately, run positive and negative controls from time to time. The Truenat® Sample Prep Device and PCR using Truenat® HCV test. The data obtained positives. The total number of runs between the 2 users was 80 runs which
Positive Control Kit-Panel II (REF 801020008) containing Positive Control was analyzed by probit analysis. LoD for the blood was determined to be comprised of 40 positives and 40 negatives. The results showed no carryover
and Negative Control must be ordered separately. It is advisable to run 1153.94 IU/mL with 95%CI of 1019.44 to 1351.21 IU/mL. contamination under the tested conditions.
controls under the following circumstances: • Whenever a new shipment of
test kits is received. • When opening a new test kit lot.• If the temperature of the
+30°C Limit of detection for different HCV genotypes: Truenat® HCV performance on different genotype panels:
+2°C storage area falls outside of 2-30° C.• By each new user prior to performing LoD for various HCV genotypes was estimated using quantified clinical To determine the performance of Truenat® HCV on different genotype panels a
testing on clinical specimen. samples obtained from Discovery Life Sciences. sample panel comprising of all possible HCV genotypes (ten numbers each of
Limit of detection for plasma and serum for genotypes 2 to 6: A dilution genotype 1, 3, 4 and three numbers each of genotypes 2, 5 and 6) was tested.
18. DISPOSAL AND DESTRUCTION series ranging from 4000, 2000, 1000, 500, 250, 125, 62.5 and 0 IU/mL were Truenat® HCV test was able to detect all the HCV genotypes.
1. Submerge the used Truenat® HCV chip, microtube, microtube cap, made in plasma and serum matrix for genotypes 2 to 6. Each dilution was
transfer pipette, pipette tips, lysis buffer tube etc. in freshly prepared 0.5% extracted (3x8=24 runs) over a period of 3 different days using 2 lots of Determination of sample equivalence:
sodium hypochlorite solution for 30 minutes before disposal as per the reagents. The number of runs accounted for 48 replicates for each dilution Sample equivalence was demonstrated for the plasma, serum, venous and
standard medical waste disposal guidelines. using both the lots (Lot 1 & Lot 2) comprising of sample prep on Trueprep® finger prick blood specimens. The panel comprised of 25 positive and 25
2. Disinfect the solutions and/or solid waste containing biological samples AUTO Universal Cartridge Based Sample Prep Device and PCR using negative specimens for each claimed specimen type. Each sample was
before discarding them according to local regulations. Truenat® HCV test. The data obtained was analyzed by probit analysis. subjected for nucleic acid isolation on Trueprep® AUTO followed by PCR on
3. Samples and reagents of human and animal origin, as well as Limit of detection for blood: A dilution series ranging from 3000, 2500, Truelab® using Truenat® HCV test using one lot of reagents. The Truenat®
contaminated materials, disposables, neutralized acids and other waste 2000, 1500, 1000, 500, 250, and 0 IU/mL were made in negative blood matrix. HCV test was able to detect HCV in each of the 25 HCV positive specimens of
materials must be discarded according to local regulations after Each dilution was extracted (3x8=24 runs) over a period of 3 different days plasma, serum, venous and finger prick blood specimens as positive and each
decontamination by immersion in a freshly prepared 0.5% of sodium using 2 lots of reagents. The number of runs accounted for 48 replicates for of the 25 HCV negative specimens of plasma, serum, venous and finger prick
hypochlorite for 30 minutes (1 volume of 5% sodium hypochlorite for 10 each dilution using both the lots (lot 1 and lot 2) comprising of sample prep on blood specimens as negative.
volumes of water). Trueprep® AUTO Universal Cartridge Based Sample Prep Device and PCR
4. Do not autoclave materials or solutions containing sodium hypochlorite. using Truenat® HCV test. The data obtained was analyzed by probit analysis. Precision:
5. Chemicals should be handled in accordance with Good Laboratory Precision for blood: The purpose of this study is to determine the
Genotype LoD Plasma LoD Serum LoD Blood
Practice and disposed off according to the local regulations. repeatability of Truenat® HCV test. The study was performed on a sample
LoD: 166.61 IU/mL with LoD: 240.92 IU/mL with LoD: 1281.78 IU/mL with 95%
2 95% confidence interval 95% confidence interval confidence interval of 1013.87-
panel comprising of 1 negative specimen, 1 low positive specimen with a viral
19. SPECIFIC PERFORMANCE CHARACTERISTICS of 144.28 - 203.35 IU/mL of 171.92- 503.41 IU/mL 1870.40 IU/mL load of (3xLLOQ) and 2 specimens in the middle and upper range of linearity of
Traceability to the WHO standard: The Truenat® HCV assay is LoD: 154.34 IU/mL with LoD: 275.07 IU/mL with LoD:1269.98 IU/mL one HCV genotype spiked into blood as the sample matrix. The study was
standardized to the 6th WHO NIBSC International Standard for Hepatitis C 3 95% confidence interval 95% confidence interval with 95% confidence interval of
of 134.74 - 186.05 IU/mL of 237.80- 333.51 IU/mL 1004.94-1849.57 IU/mL spread over a period of 20 consecutive days. Every day each sample panel
virus for Nucleic acid amplification Techniques (NIBSC Code 18/184).
LoD: 183.79 IU/mL with LoD: 291.33 IU/mL with LoD:684.84 IU/mL
member was tested in replicates of 2 including nucleic acid isolation on
Analytical specificity/Cross reactivity: 4 95% confidence interval 95% confidence interval with 95% confidence interval of Trueprep® AUTO followed by PCR on Truelab® using three different lots of
The cross reactivity with other organisms unrelated to hepatitis C was of 158.92 – 224.95 IU/mL of 210.14-580.30 IU/mL 500.81-1384.79 IU/mL reagents, at one site, by single user. The analysis of the CV values obtained
LoD: 191.56 IU/mL with LoD: 265.43 IU/mL with LoD: 1273.95 IU/mL
determined by spiking negative plasma with concentration of 106 CFU/mL of 5 95% confidence interval 95% confidence interval with 95% confidence interval of between the 3 reagent lots is within the accepted range of ≤15%.
bacterial and 106 TCID50/mL of viruses and 106 copies/mL of nucleic acids of 165.91 - 233.85 IU/mL of 229.60 - 321.45 IU/mL 1019.63 – 1806.11 IU/mL
LoD: 183.69 IU/mL with LoD: 328.60 IU/mL with LoD: 1339.45 IU/mL
respectively. Similarly positive specimens were prepared by spiking negative 6 95% confidence interval 95% confidence interval with 95% confidence interval of Precision for plasma: The purpose of this study is to determine the
plasma with 3-4X LoD of HCV armored RNA along with 106 CFU/mL of of 158.67 - 225.02 IU/mL of 231.24 - 736.43 IU/mL 1025.70- 2129.29 IU/mL repeatability of Truenat® HCV test. The study was performed on a sample
bacterial and 106 TCID50/mL of viruses and 106 copies/mL of nucleic acids of Robustness: panel comprising of 1 negative specimen, 1 low positive specimen with a viral
the respective organism. Both the HCV negative and positive samples were The purpose of the study was to determine if there was a potential for carry- load of (3xLLOQ) and 2 specimens in the middle and upper range of linearity of
subjected to sample prep on Trueprep® AUTO Universal Cartridge Based over between samples, which could be a source of contamination. This was one HCV genotype spiked into plasma as the sample matrix. The study was
Sample Prep Device and PCR was performed in triplicates for HCV negative tested on a single Trueprep® AUTO Universal Cartridge Based Sample Prep spread over a period of 20 days. Every day each sample panel member was
and HCV positive samples containing the test organism for cross reactivity. Device and a single Truelab® Uno Dx Real Time micro PCR Analyzer. tested in replicates of 2 including nucleic acid isolation on Trueprep® AUTO
The results showed no cross-reactivity of Truenat® HCV to any of the Alternate positive and negative samples were subjected to sample prep followed by PCR on Truelab® using three different lots of reagents, at one site,
organisms listed. followed by PCR. Devices were placed adjacent to each other to mimic a by single user. The analysis of the CV values obtained between the 3 reagent
Organisms Organisms typical use case scenario. The results showed no carryover contamination lots is within the accepted range of ≤15%.
Banzi virus Ilheus virus under the tested conditions.
BK Human polyoma virus Influenza B virus Precision for serum: The purpose of this study is to determine the
Cytomegalovirus Measles Reproducibility: repeatability of Truenat® HCV test. The study was performed on a sample
Dengue virus Type 1 St. Louis encephalitis virus panel comprising of 1 negative specimen, 1 low positive specimen with a viral
The purpose of the study is to determine the reproducibility of the Truenat®
Dengue virus Type 2 Vaccinia virus load of (3xLLOQ) and 2 specimens in the middle and upper range of linearity of
Dengue virus Type 3 Varicella Zoster virus HCV assay. The study was performed on a sample panel comprising of 1
negative specimen, 1 low positive specimen (3 x LLOQ) and 2 specimens in one HCV genotype spiked into serum as the sample matrix. The study was
Dengue virus Type 4 West Nile virus
Epstein Barr Virus Yellow fever virus the middle and upper range of the linearity span, respectively for all the spread over a period of 20 days. Every day each sample panel member was
Hepatitis A virus Zika virus claimed specimen types. The study was spread over a period of 5 days. Every tested in replicates of 2 including nucleic acid isolation on Trueprep® AUTO
Hepatitis B virus Candida albicans day each sample panel member was tested which included nucleic acid followed by PCR on Truelab® using three different lots of reagents, at one site,
Hepatitis E virus Chlamydia trachomatis isolation on Trueprep® AUTO followed by PCR on Truelab® using one lot of by single user. The analysis of the CV values obtained between the 3 reagent
Herpes simplex virus 1 Leishmania donovani reagents, at three different sites, using 1 operator/site. Testing was conducted lots is within the accepted range of ≤15%.
Herpes simplex virus 2 Maycobacterium tuberculosis by operator's representative of intended users in addition to members of
Human herpes virus 6 Mycobacterium gordonae Whole system failure: Whole system failure rate was performed utilizing
manufacturer's staff unassisted. The reproducibility for the Truenat® HCV
Human herpes virus 8 Mycobacterium smegmatis blood sample spiked at 3X LoD with NIBSC 6th WHO International Standard for
Human Immunodeficiency virus 1 Neisseria gonorrhoeae
assay performed at 3 study sites showed reproducible results. For Plasma
specimens %CV values for Inter site, Inter user and Inter day study were in the Hepatitis C virus RNA. The study was performed on a sample panel of 100
Human Immunodeficiency virus 2 Plasmodium falciparum
Human papilloma virus 16 Staphylococcus aureus range of 1.34 to 20.27. For Blood specimens %CV values for Inter site, Inter numbers spread over 5 consecutive days. Every day 20 samples were utilized
Human papilloma virus 18 Staphylococcus epidermidis user and Inter day study were in the range of 1.48 to 13.31. For Serum for nucleic acid isolation on Trueprep® AUTO followed by PCR on Truelab®
Human T-cell lymphotropic virus I Trichomonas vaginalis specimens %CV values for Inter site, Inter user and Inter day study were in the using Truenat® HCV test using one lot of reagents and by single user. Since
Human T-cell lymphotropic virus II range of 1.44 to 14.18. the study had to be performed on high viscosity sample, blood was chosen as
the sample matrix. No runs showed false results. The observed standard Results: The sensitivity and specificity of Truenat® HCV RNA test in
deviation across the 100 runs was 0.35 with a %CV of 11.30. fingerstick whole blood (venous) samples was 91.13% and 98.40%,
respectively. In plasma samples, the sensitivity of the Truenat® HCV RNA test
Trueness of measurement: Trueness of the IVD was demonstrated by was 93.20%, while the specificity was same as that of the capillary blood
comparison of the performance of the Truenat® HCV test with Abbott Real-time specimens. In serum specimens the sensitivity and specificity were 97.83%
HCV Genotype II Assay. A total of at-least 100 specimens positive for HCV and 100%. In venous blood specimens sensitivity and specificity was 96.77%
RNA, with viral loads covering the entire linear range of the IVD covering and 98.68% respectively. Further the specificity in healthy blood donor
relevant and as many different genotypes with all claimed specimen types. Two populations was 99.6%.
lots of reagents were utilized for the study. The entire sample panels which
were positive by comparator Abbott Real-time HCV Genotype II Assay was Specimen Type Sensitivity Specificity
positive by the Truenat® HCV test also.
Plasma 93.20% 98.40%
Stability of samples (blood/plasma/serum): (95% CI 90.74 - 94.75) (95% CI 96.56 - 99.27)
The study was performed as per the WHO PQ requirement document (TSS-10 Serum 97.83% 100%
(Draft) In vitro diagnostic (IVDs) medical devices used for the qualitative and (95% CI 92.42 - 99.4) (95% CI 97.54 - 100)
quantitative detection of hepatitis C RNA). Stability of samples was tested on
various sample types consisting of whole blood, plasma and serum as sample Venous Blood 96.77% 98.68%
types on a 10 member sample panel prepared by spiking 3xLoD of confirmed (95% CI 90.94–98.9) (95% CI 95.33 - 99.64)
HCV positive sample into 10 different confirmed respective negative
specimens. Fingerstick whole 91.13% 98.40%
blood (95% CI 88.63 - 93.23) (95% CI 96.56 - 99.27)
Stability at -80°C: The samples were stored at -80°C at different time periods
of 0hrs, week 1, week 2, week 3, week 4, week 5, week 6 and week 7 Conclusions: The diagnostic accuracy of the Truenat® HCV RNA test is high
respectively in a -80°C freezer placed in a room having relative humidity in all specimen types used, confirming that the assay can be used for
ranging from 57 to 69% and temperature of the room ranging from 18.4 to diagnosis and confirmation of active hepatitis C virus infection at point-of-care
23.9°C. The samples were processed on Trueprep® AUTO Universal settings thus facilitating access to testing.
Cartridge Based Sample Prep Device followed by PCR on Truenat® HCV test.
The 10 member sample panel of plasma, blood and serum was found to be 20. REFERENCES
stable till week 7 at -80°C. 1. World Health Organization. "Hepatitis C.” (Http://www.who.int/
Stability at -20°C: The samples were stored at -20°C at different time periods mediacentre /factsheets/fs164/en/)
of 0 hrs, week 1, week 2, week 3, week 4, week 5, week 6 and week 7 2. Centers for Disease Control and Prevention. "Hepatitis C."
respectively in a freezer placed in a room having relative humidity ranging from (http://www.cdc.gov/ hepatitis/hcv)
57 to 69% and temperature of the room ranging from 18.4 to 23.9°C. The 3. Gower, Erin, et al. (2014) "Global epidemiology and genotype distribution
samples were processed on Trueprep® AUTO Universal Cartridge Based of the hepatitis C virus infection." Journal of Hepatology, 61(1), S45-S57.
Sample Prep Device followed by PCR on Truenat® HCV test. The 10 member 4. Lozano, Rafael, et al. (2013) "Global and regional mortality from 235
sample panel of plasma, blood and serum was found to be stable till week 7 at - causes of death for 20 age groups in 1990 and 2010: a systematic analysis
20°C. for the Global Burden of Disease Study 2010." The Lancet, 380(9859),
2095-2128.
Stability at 4°C: The samples were stored at 4°C at different time periods of 5. Morgan, Rebecca L, et al. (2013) "Eradication of hepatitis C virus infection
0hr, 4hrs, 8hrs, 24hrs, 48hrs, 72hrs, 96hrs and 5 days in a refrigerator placed in and the development of hepatocellular carcinoma: A meta-analysis of
a room having relative humidity ranging from 56 to 60% and temperature of the observational studies." Annals of Internal Medicine, 158(5), 329-337.
room ranging from 22 to 24.5°C. The samples were processed on Trueprep® 6. Scott, John D and Gretch DR (2007) "Molecular diagnostics of hepatitis C
AUTO Universal Cartridge Based Sample Prep Device followed by PCR on virus infection: a systematic review." JAMA, 297(7), 724-732.
Truenat® HCV test. The 10 member sample panel of plasma and serum were 7. Ghany, Marc G, et al. (2009) "Diagnosis, management, and treatment of
found to be stable till 8hrs at 4°C, whereas blood was stable till 4hrs at 4°C. hepatitis C: an update." Hepatology, 49(4), 1335-1374.

Stability at 35°C: The samples were stored at 35°C at different time periods of 21. REVISION HISTORY
0hr, 4hrs, 8hrs, 24hrs, 48hrs, 72hrs respectively in an incubator placed in a Section Description of the changes
room having relative humidity ranging from 51 to 59% and temperature of the Throughout Symbols are added as per IVDR requirements
room ranging from 23.6 to 25.9°C. The samples were processed on Trueprep® 3 Principle of the test is updated
AUTO Universal Cartridge Based Sample Prep Device followed by PCR on 8 Section is updated
Truenat® HCV test. The 10 member sample panel of plasma, blood and serum 21 Added Revision History table
was found to be stable till 4hrs at 35°C. Symbol keys Symbol keys are updated

Stability of samples after freeze thaw: Stability of samples after freeze thaw
was tested on various sample types consisting of whole blood, plasma and
serum as sample types on a 10 member sample panel prepared by spiking
3xLoD of confirmed HCV positive sample into 10 different confirmed respective
negative specimens. The samples were frozen at -20°C and subjected to 5
freeze thaw cycles. The samples were processed on Trueprep® AUTO
Universal Cartridge Based Sample Prep Device followed by PCR on Truenat®
HCV test to determine the effect of freeze thaw process on stability of HCV
RNA. The 10 member sample panel of plasma, blood and serum was stable
even after 5 freeze thaw cycles.

Clinical validations:
a) Clinical validation 1:
A panel of 100 plasma samples comprising of 69 negatives and 31 positive
specimen were tested on three different manufacturing lots of Truenat® HCV
assay at AIIMS (All India Institute of Medical Sciences, New Delhi) against the
AIIMS inhouse HCV PCR assay which is validated against 3rd HCV WHO
International Standard. All the positive samples were also run in parallel with
AIIMS in house PCR assay and Sacace- Real Time PCR kit for the quantitative
detection of HCV (REF- V1-96/3FRT- a CE-IVD kit) for comparing the viral
loads obtained by these Truenat® HCV lots.
Specificity: All 69 negative specimens by AIIMS assay were also found to be
negative by the 3 lots of Truenat® HCV assay, showing a 100% specificity.
Sensitivity: All 31 positive specimen results correlated between the methods
giving a sensitivity of 100% for the 3 different manufacturing lots of Truenat®
HCV assay.

Concordance of viral loads:

The viral loads obtained by the Truenat® HCV assay on the 31 positive
samples were compared with the loads obtained by the AIIMS in house PCR
and Sacace-Real Time PCR kit. The viral loads of the samples ranged from ~
200 IU/mL to 4500000 IU/mL. Satisfactory concordance well within the
acceptable deviation of 0.5 log IU/mL was observed showing a good
correlation between the assays and good lot to lot consistency of the Truenat®
HCV assay.

b) Clinical validation 2:
A blind panel of 318 plasma samples pre-analyzed by FIND using the Roche
HCV assay was provided for verification of the Truenat® HCV Assay. The final
results, upon unblinding by FIND showed a concordance of 98.4% between
the 2 assays.
2X2 Table
Roche Positive Roche Negative Total
Truenat® HCV Positive 119 5 124
Truenat® HCV Negative 0 194 194
318

All the 5 Truenat® HCV positive and Roche negative samples also tested
positive with Altona HCV CE-IVD kit.

c) Multicentric clinical evaluation study for Truenat® HCV test:

FIND conducted a multicentric prospective diagnostic clinical study to
evaluate the performance of the Truenat® HCV test using samples collected
from 1527 participants from clinical sites located in Georgia, Ukraine, Ethiopia,
Thailand and Denmark. The study was conducted on plasma, serum and
whole blood (venous) specimens. Fingerstick whole blood (venous) was also
included as a specimen type in this study to check feasibility and compare with
whole blood / plasma / serum. Respective samples were collected freshly from
intended use population which included individuals presenting at a healthcare
facility for HCV confirmatory testing following a positive HCV serology test
result or exposure to risk factors, and individuals who completed anti-HCV
treatment and present for a test of cure. Additionally, to confirm clinical
specificity, the Truenat® HCV RNA test was conducted on 500 freshly collected
venous blood specimens from healthy blood donors in Denmark. Specimens
from each participant were tested by the Truenat® HCV RNA test. Sensitivity,
specificity and quantitative accuracy of the Truenat® HCV RNA test was
evaluated using the Abbott RealTime HCV assay as a reference method.
 for use.
®

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