REF 08FK50

Abbott

Bioline
TB Ag MPT64
Test for the identification of Mycobacterium tuberculosis Complex by rapid test
Test pour l'identification du complexe Mycobacterium tuberculosis par test rapide
ldentificación del complejo Mycobacterium tuberculosis por una prueba rápida
ldentificação do complexo Mycobacterium tuberculosis através de um teste rápido
Nachweis des Mycobacterium tuberculosis -Komplexes mittels Schnelltest
ldentificazione del complesso Mycobacterium tuberculosis con test rapido

ENGLISH

About the test Test procedure (Refer to figure)

[Introduction] Tuberculosis is a highly infectious disease caused 1. Remove the test device from the foil pouch, and place it
by Mycobacterium tuberculosis and potentially fatal disease of on a flat, dry surface.
human. Biochemical, immunological and molecular biological 2. Add 100 pl of liquid cultures (or 100 ul of suspended solid
characterization of Mycobacterium tuberculosis has led to the cultures in buffer) into the specimen well C'S").
identification of several antigens which may be useful in the 3. As the test begins to work, you will see purple color move
across the result window in the center of the test device.
development of improved diagnostic methods in order to dis-
criminate between the M. tuberculosis complex and mycobacteria 4. Interpret the test results in 15 minutes after specimen
other than M. tuberculosis (MOTT bacilli). M. tuberculosis has application.
been known to secrete more than 33 different proteins. One of Caution: Do not read testresults after 15 minutes;
the predominant proteins, MPT64 was found in the culture fluid
reading after 15 minutes can yield false results.
of only strains of the M. tuberculosis complex.
[Principle] This test cassette consists of a sample pad, a gold
conjugate pad, a nitrocellulose membrane, and an absorbent pad. Test interpretation (Refer to figure)
Mouse monoclonal anti-MPT64 were immobilized on the nitro- 1. A color band will appear at left section of the result
cellulose membrane as the capture material (test line). Another window to show that the test is working properly. This
antibodies, which recognized another epitope of MPT64, conju band is the Control Band.
gated with colloidal gold particles were used for antigen capture The right section of the result window indicates the test
and detection in a sandwich results. If another color band appears at the right section
tyYpe assay.
Bioline" TB Ag MPT64 test device has a letter of T and C as of the result window, this band is the Test Band.
lest Line" and "Control Line" on the surface of the case. Both Negative result: The presence of only control band ("C"
the "Test Line" and "Control Line" in result window are not visible
band) within the result window indicates a negative result.
betore applying any specimens. The "Control Line" is used for
Positive result: The presence of two color bands ("T" band
procedural control. Control line should always appear if the test and "C" band) within the reult window, no matter which
procedure is performed properly and the test reagents of control band appears first, indicates a positive result.
line àre As the test
work1ng. specimen applied in the specimen /Caution: The presence of any test line, no matter
well flow laterally through the membrane, the antibody-colloidal how faint, the result is considered positive.
gold conjugate binds to the MPT64 antigen in the specimen,
liq
uid media. The complex then flows further and bind to the mouse
Note:
Depending on the MPT64 antigen concentration, the
monoclonal anti-MPT64 on the solid
phase in the test line, pro- intensity on test line may vary.
ducing red to purple color band. In the absence of MPT64, there
A positive result will not change once it has been estab
is no line in the test band
region. lished at 15 minutes.
[Intended use] Bioline"" TB Ag MPT64 is a rapid immunochro- Invalid result: If the control band is not visible within the
matographic identification test for the M. tuberculosis complex result window after performing the test, the result is
that use mouse monoclonal anti-MPT64. This test kit can be eas- con
sidered invalid. The directions may not have been followed
ily used for rapid identification of the M. tuberculosis complex in
correctly or the test may have deteriorated. It is recom-
combination with culture systems based on liquid media without
mended that the specimen should be retested.
any technical complexity in clinical laboratories.
 Test limitations
Materials provided and active ingredients of
Although the Bioline TB Ag MPT64 test is very accu-
main components rate in
1. The Bioline" TB
detecting MPT64 antigen, a low incidence of false
Ag MPT64 test kit contains the follow results can occur.
ng items to pertorm the assay. Other
clinically available tests are required if questionable
25lestdevices individually foil pouched with a dessicant results are obtained.
Extraction buffer (1 x 10 ml/vial) (for specimen prepara As with all diagnostic tests, a definitive clinical
tion from solid cultures) diagnosis
should not be based on the results of a single test, but
1 Instructions for use should only be made by the physician after all clinical and
Active ingredients of main components
laboratory findings have been evaluated.
I test strip includes: Gold conjugate : Mouse monoclonal anti-
MPT64 gold colloid (0.240:0.048 pg, Test line : Mouse
monoclonal anti-MPI64 antibody (O.320:0.064 pg), Control
Internal quality control
Bioline" TB Ag MPT64 test device has a letter of T and C as
line: Goat anti-mouse
immunoglobuin G (0.640 :0.128
pg) "lest Line" and "Control Line" on the surface of the case. Both
Extraction buftfer: 10OmM Phosphate Buftfer (10 ml),
the "lest Line" and "Control Line" in result window are not VIS-
Sodium azide (0.1 %)
ble before applying any specimens. The "Control Line"is used

for procedural control. The control line of the RDT only shows
Kit and
1.
storage stability
The test device should be stored at 1-30°C. Do not freeze
that the diluent has been applied successfully, and that the active

ngredients of main components on the strip was still functional,

the kit or components. but is not a
The test device is sensitive to both heat and
guarantee that the specimen has been properly ap
humidity. plied and does not represent a positive specimen control.
Pertorm the test immediately atter removing the test
device trom toil pouch.
Do not use it beyond the exp1rat1on date. Expected values
The shelf-life of the kit is as indicated In the recent evaluation study of Bioline TB Ag MPT64 test
on outer
5. Do not store the test kit in direct package. kit in combination with culture systems based on liquid media,
6. Do not use the test kit if the sunlight. strong positive bands against the bacteria belonging to the Myco-
seal is broken. pouch is
damaged or the
bocterium tuberculosis complex, M. tuberculosis, M. ofricanum, and
M. bovis were demonstrated, while no positive signal was observed

for the MOTT bacilli tested.

Warnings For in vitro
diagnostic use
only. Do not reuse test device.
For rapid identitication test ot the M. tuberculosis
trom the liquid and solid cultures. complex Product. disclaimer:
Do not eat or smoke while Whilst every precaution has been taken to ensure the
4. Wear
handling specimens.
protective gloves and mask while diagnostic ability and accuracy of this product, the product
specimens. Wash hands thoroughly afterwards.
handling s USed outside of the control of the manufacturer and
S. Clean up spills distributor and result may
accordingly be
thoroughly using an appropriate offected by
environmental factors and/or user error. The subject of the
disinfectant.
O. Decontaminate and dispose of all specimens, reaction kits diagnosis should consult a doctor for further conturmotion of
and the test result.
potentially contaminated materials, as if they were
intectious waste, in a biohazard container.
Do not drink extraction buftfer. Warning:
o. he extraction butter contains a proprietary anti-micro- The manufocturers and distributors of this product shall not
bial agent, sodium az1ide, which presents no hazard to the be liable for any Girect, indirect, or consequential losses,

user it normal laboratory safety precautions are followed. liability, claims, costs or damages arising from or related to
an incorrect
If contact with extraction buffer to the eyes andlor skin, positive or negative diagnosis using this product.
wash aftected area with soap and water immediately. If ir-
ritation or signs of toxicity occur, seek medical attention.

Specimen collection and handling

1 Liquid cultures
00 pl ot specimen taken from liquid cultures processed by
sputum specimen can be applied directly to the specimen well
S)without use of the specimen preparation procedure.
Solid cultures
LColony]
For specimen preparation from solid cultures, 3-4 colo-
nies should be suspended in 200 pl of extraction buffer
prior to test.

[Condensation fluid]
IF there is condensation fluid of slant agar tubes, 100
of specimen taken from condensation fluid can be ap-
plied directly to the specimen well ('S), or colonies can be
suspended in this condensation fluid instead of extraction
buffer.

Performance Characteristics
Sensitivity
Test method
lsolated culture method
M.tuberculosis lsolated from M.tuberculosis isolated from clinical lotal
clinical specimens (MGI) specimens 3% ogawa medium)
Bioline TB Ag Positive
158 216
MPT64
Negative 2

Total 60
159
Sensitivity( 98.67% (216/219)

Specific
Test method Isolated culture method

Bacterial Fungal strains Non-tuberculous Non-tuberculous Total

strains mycobacterium strains mycobacterium isolated from
specimens
Bioline" TB Positive 0 0 O
gMPT64
Negative 137 15 | 57 51 260
Total 137 15 57 260
Specificity () 100% (260/260)
Heproducibility of Bioline" TB Ag MPT 64 has been demonstrated by studies (within-run, between-run and batch-to-batch)
with in-house reference panels. All values were identical to reference panel acceptance criteria.
 AEF 08FK5o
LIQUID CULTURES/CULTURES LIQUIDES/CULTIVOS LÍQUIDOS
CULTURAS LÍQUIDAS/ FLUSSIGKULTUREN/COLTURE LIQUIDE
Abbott Take 100 pl of specimen from liquid cultures.

1 Prélever 100 pl déchantillon issu d'une culture en milieu liquide.

Tome 100 pl de cultivos liquidos.
Retire 100 pl de amostra de culturas liquidas.
Bioline 1 0 0 pl der Probe aus Flüssigkulturen entnehmen.
100 pl
TB Ag MPT64 U Prelevare 100 pl di campione da colture liquide.

Add 100 pl of liquid cultures into the specimen well.

est for the identification of Mycobacterium tuberculosis Complex by rapid test
p o u r dentification du complexe Mycobacterium tuberculosis par test rapide
enticación del complejo Myeobocterium tubereulosis por una prueba rápida
2 E

E
Ajouter 100 pl de culture liquide dans le puits echantillon.

Agregue 100 pl de cultivos liquidos en el pozo de muestra

dentificação do complexo Mycobacterium tuberculosis atraves de um teste rapiao
Nachweis des
Myeobocteriumtuberculosis
-Komplexes mittels Sehneltet PD Adicione 100 pl de cilturas liquidos ao poço da arnostra. 100
ldentificazione del complesso Mycobocterium tuberculosis con test rapido
1 0 0 pl der Flüssigkuturen in die Probenmulde geben.

Aggungere 100 pl di colture liquide nel pozzetto campione.

PREPARATION/PRÉPARATION / PREPARACIÓN/PREPARAÇÃO E Interpret test results at 15 minutes.

vORBEREITUNG/ PREPARAZIONE 3 Interpreter les résultats à 15 minutes.

ES Interpretar los resultados de la prueba a los l5 minutos. 15

Ouvrir le kit et vérifier la ES Ahora, abra el empaque y busque
Now, open the package and Interprete o resultado do teste ao fim de 15 minutos. MIN
look for the followin presence des différents a continuación:
1. Dispositivos de prueba es 15 Minuten ablesen.
1. lest devices indvidually composants suivants:
O9 Die lestergebnisse nach genau
foil pouched with a Cassette test dans son empacado en una bolsa de
esattamente 15 minuti.
emballage individuel avec aluminio con un desecante Interpretare risultati dopo
i

desiccan
2. Extraction buffer dessicant de forma individual

3. Instruction for use ampon d extraction 2. lampon de extraccion EN Caution: Do not read test results after 15 minutes; reading after 15 minutes can yield false results.
Mode d'emploi 3. Instrucciones para el uso
E Attention: Ne pas lire les resultats au-dela de l minutes; une lecture intervenant
après15 minutes
peut donner des résultats errones.
öffnen und Aprire la confezione e individuare i
Agora, abraaembalageme Die Verpackung
procure o seguinte: überpruten, ob die folgenden Seguenti componenti: Atención: No interprete los
resultados de la prueba
despues de que hayan transcurrido 15
1. Dispositivos de teste Komponenten enthalten sind: 1. Dispositivi di test confezio- minutos puede producir talsos resultados.
minutos; la interpretación despues de 15
ndividualmente 1. lestvorrichtungen nato singolarmente in busta
Atenção: Não leia os resultados do teste apos 15 minutos; a leitura posterior aos 15 minutos
embalado em bolsa einzeln in einer Folie di allumin1o sigillata, con
de oluminio com um verpackt, mit einemn pode gerar resultados falsos.
SICCante
dessecante Trockenmittel ampone di estrazione 09 Vorsicht: Das Testergebnis nicht nach mehr als 15 Minuten ablesen; das Ablesen nach mehr als
2. lampão de extração 2. Extraktionspuffer Istruzioni per luso 5 Minuten kann zu falschen Ergebnissen fuhren.
3. Instruções de utilização 3. Gebrauchsanweisung
Attenzione: non leggere I risultati del test dopo oltre 15 minut1; la lettura dopo oltre 15 minuti

puo produrre risultati errati.

E First, read carefully the L i r e attentivement la notice ES Primero, Lea cuidadosamentelas

2 instruction on how to use the

Bioline TB Ag MPT 64 test
du kit de Bioline" TB Ag
MPT 64.
instrucciones sobre como usar
el kit de prueba Bioline TB Ag sOLID CULTURES/CULTURES SOLIDES CULTIVO SÓLIDO
MPT 64.
Kit.
CULTURAS sÓLIDAS/ FESTKULTUREN /COLTURE SOLIDE
O Lesen Sie zunachst die
PT Primeiramente leia
Innanzitutto, legeere con
cuidadosamente as instruções sebrauchsanweisung fur das attenzione le istruzioni per luso Condensation fluid of slant agar tubes / Liquide de condensation sur milieu solide en tube
de como usar o teste Bioline" TB Ag MPT 64 del kit di analisi Bioline" 1B Ag
Fluido de condensación/Liquido de condensação de tubos de agar inclinado / Kondensations-
Bioline" TB Ag MPT 64. lestset autmerksam durch. T 64.
flüssigkeit aus Schrägagarröhrchen Condensation fluid ofslant agar tubes

E Next, look at the expiry date Vérifier la date de ES Luego, veritique la fecha de Take 100 pl of suspended solid cultures in buffer.

3 at the back of the foil pouch.

Use another kit, if expiry date
peremption au verso de

enveloppe protectrice.
Utiliser un autre kit si la date
vencimiento en la parte posterior
de la bolsa de aluminio. Use otro
kit, si la fecha ha expirado.
Prelever 100 pl de liquide de condensation.
Tome 100 pl de cultivos en placa suspendidos en búfer.
has passed.
de pêremption est depassee. Retre 100 pl de culturassolidas em suspensão em solução tampão.

Observe a data de validade Danach das Verfallsdatum Controllare la data di scadenza 100 pl derim Puffer suspendierten Festkulturen entnehmen. 100
atrás do envelope. Use outro auf der Ruckseite des sul retro della busta di alluminio.
Prelevare 100 pl di sospensione di colture solide in tampone.
Kit caso a data de validade Folienbeutels prufen. Wenn Se il kit é scaduto, utilizzarne un

tenha expirado. das Verfallsdatum abgelaufen altro.

ist, ein anderes lestset
EN Add 100 pl of suspended solid cultures in buffer into the specimen well.

Open the foil pouch and look

verwenden.

uvrir l'enveloPpe et Abra el empaque de aluminio y

2 Ajouter dans le puits échantillon les 100 pl du liquide de condensation.
Arada 100 pl de cultivos en placa suspendidos en búfer en el pozo de muestra.
for the following: vérifier l'intégrité des points busque lo siguiente:
Adicione 100 pl de culturas sólidas em suspensão em solução tampão
100 p
1. Dispositivo de prueba
1.est device Sulvants:
1. Dispositit de test 2. Desecante
no poço da amostra.
2. Desiccant
Ihen, label the device with 2. Agent déshydratant Luego, etiquete el dispositivo de 100 pl der im Puffer suspendierten Festkulturen in die Probenmuldegeben
the patient identitier. Apposer ensute une etiquette prueba con un identificador del nel
ndiquant lidentifiant du patient Aggungere 100 pl di sospensione di colture solide in tampone
paciente pozzetto campione.
sur le dispositif de test.

Abra a bolsa de folha O9 Den Folienbeutel öffnen Aprire la busta in alluminio

und überprüfen, ob die
3
de aluminio e procure o eindividuare I seguenti Interpret test results at 15 minutes.

uinte: folgenden Komponenten omponenti: Interprêter les résultats à 15 minutes.

enthalten sind: 1. Dispositivo di test
.DIspoSitivo de teste
2.Em Dessecante
seguida, coloque uma
1. Testkassette 2. Essiccante
Etichettareil dispositivo di test
ES Interpretar los resultados de la prueba a los 15 minutos. 15
MIN
etiqueta no dispositivo com o
2. Trockenmittel Interprete o resultadodo teste ao fim de 15 minutos.
Beschritten Sie dann das con un identificativo del paziente.
identificador do paciente. Gerät mit der Patienten-ID. 09 Die Testergebnisse nach genau 15 Minuten ablesen.

Interpretare I risultati dopo esattamente 15 minuti.

2
Caution : Do not read test results after 15 minutes; reading after 15 minutes can yield false results.

E/Attention: Ne pas lire les résultats au-del de 15 minutes; une lecture intervenant apres 15
minutes peut donner des résultats erronés.

Atención: No interprete los resultados de la prueba despues de que hayan transcurrido 15

SILICAGEL
DO NOT EA minutos; la interpretacion despues de 15 minutos puede producir talsos resultados,

Atenção: Nao lera os resultados do teste apos 15 minutos; a leitura posterior aos 15 minutos
pode gerar resultados talsos.

9 Vorsicht: Das Testergebnis nicht nach mehr als 15 Minuten ablesen; das Ablesen nach mehr als
15 Minuten kann zu falschen Ergebnissen tuhren.
100pl Specimen 100 pl/Echantillon 100 l/ Muestra de 100 p
/ 100 plde anostra/100 pl probe / 100 pl di compione JAtenzione: non leggere i risultati del test dopo oltre 15 minuti; la lettura dopo oltre 15 minuti
puo produrre risultati errati.
 SOLID CULTURES/ CULTURES SOLIDES/CULTIVO SÓLIDO
CULTURAS sÓLIDAS/FESTKULTUREN/COLTURE SOLIDE INTERPRETATION/INTERPRÉTATION/INTERPRETACIÓN
INTERPRETAÇÃO ERLÄUTERUNG/INTERPRETAZIONE
Colony/ Colonie l colonia / Colónia / Kolonie / Colonia NEGATIVE/ NÉGATIF/ NEGATIVo/ NEGATIVOI NEGATIV
INEGATIVo
Take 200 pl of extraction butter and move it into the
test tube. No Mycobacterium tuberculosis antigen
Prelever 200 pl de reactit dextraction et les ajouter
Pas d'antigène M. tuberculosis
dans un tube à essai.

ES lome 200 pl de buter de extraccion y moverlo al tubo ES No hay antigeno de Mycobocterium tuberculosis
de ensayo. 200 l N o hay antigeno de Mycobacterium tuberculosis
Retire 200 pl de soluçao tampao de extracçào e
C
coloque -a no tubo de teste. Kein Mycobacterium tuberculosis Antigen
2 0 0 pl des Extraktionsputfers entnehmen und in das Nessun antigene di Mycobacterium tuberculosis
Testrohrchen geben.
P r e l e v a r e 200 pl di tampone di estra7ione e trasferirlo

nella provetta campione corrispondente.

POSITIVE/ POSITIF/ POSITIVOI POSITIVO/ POSITIV/PoSITIVO

l a k e 3-d colonies from solid cultures. Mycobacterium tuberculosis antigen complex positive
2 E Prelever 3~4 colonies de la culture solide. Complexe M. tuberculosis positif
ES Tome 3-4 colonias de cultivo en placa. Complejo de Mycobacterium tuberculosis positivo
Retire 3-4 colónias de culturas sólidas. Antigenio do complexo Mycobacterium tuberculosis positivo

3-4 Kolonien aus Festkulturen entnehmen. Mycobacterium tuberculosis Antigenkomplex positiv C T

Prelevare 3 o 4 colonie dalle colture solide. Positivo al complesso antigene Mycobacterium tuberculosis

Caution : The presence ot any test line, no Atention: Si la ligne de test est presente, meme
matter how taint, the result is considered positive. tres pale, le résultat est consideré comme positif.
EN Ihoroughly mix colonies with 200 pl of extraction

3 butter,
Melanger completement les colonies dans les 200 pl de
Atención: La presencia de cualquier linea de
prueba, aunque sea de un color debil, indica que el
Atengao: Apresença de qualquer Iinha de
teste, mesmo sendo muito tenue, signitica que o
reactit dextraction.
resultado es positivo. resultado e considerado pos1tivo.
Mezcle las colonias con 200 pl de bufer de extracción.
69 Vorsicht: Das Vorliegen einer Testlinie, egal Attenzione: in presenza di qualsias1i linea, a
Misture bem as colónias com 200 pl de solugão tampão wie schwach, wird als positives Ergebnis betrachtet. prescindere dall intensita del colore, il risultatoe
de extracção. Sx considerato positivo.
O Kolonien gründlich mit 200 pl Extraktionspuffer
mischen.

Miscelare accuratamente le colonie con 200 pl di

tampone di estrazione

INVALID/ NON VALIDE/ INVÁLIDO/INVÁLIDO/UNGÜLTIG

INONVALIDO
E I t is recommended that the specimen should be retest
Add 10 ul ofsuspended solid cultures in buffer
4 into the specimen well.

E
l est recommandé de tester de nouveau l'echantillon

Se recomienda repetir la prueba de la muestra

Ajouter dans le puits échantillon, 100 pl de cette
cuiture en milleu solide remise en suspension dans PT Recomenda-se voltar a testar a amostra
le reactit dextraction.

Añada 100 pl de cultivos en placa suspendidos en 100 pl 9 Es wird empfohlen, die Proben erneut zu testen
C
T T
buter en el pozo de muestra. S i consiglia di analizzare nuovamente il campione

Adicione 100 ul de culturas solidas em suspensão

em soluça0 tampao ao poço da amostra.

1 0 0 pl der im Puffersuspendierten Festkulturen

in die Probenmulde geben.

Ageiungere 100 pl di sospensione di colture

solide in tampone nel pozzetto campione.
E
Interpret test results at 15 minutes.
5 Interpréter les résultats à 15 minutes.
6 Ihterpretar los resultados de la prueba a los 15 minutos.
15
MIN
Interprete o resultado do teste ao fim de 15 minutos.

O9 Die lestergebnisse nach genau 15 Minuten ablesen.

Interpretare i risultati dopo esattamente 15 minuti.

Caution : Do not read test results after 15 minutes; reading after 15 minutes can yield false results.

FR Attention: Ne pas lire les resultats au-dela de l5 minutes; une lecture intervenant après 15
minutes peut donner des resultats errones.

ES Atención: No interprete los resultados de la prueba después de que hayan transcurrido 155
minutos; la interpretacion despues de l5 minutos puede producir falsos resultados.

P Atenção: Näo leia os resultados do teste apos 15 minutos; a leitura posterior aos 15 minutos
pode gerar resultados falsos.
0B Vorsicht: Das Testergebnis nicht nach mehr als 15 Minuten ablesen; das Ablesen nach mehr als
15 Minuten kann zu falschen Ergebnissen führen.

O Attenzione: non leggere i risultat1 del test dopo oltre 15 minuti; la lettura dopo oltre 15 minuti
puo produrre risultati errat1.