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Infectious Mononucleosis Test Device

(Whole Blood/Serum/Plasma)

A rapid test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies

in whole blood, serum and plasma.

For professional in vitro diagnostic use only.

INTENDED USE

Infectious Mononucleosis Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic

immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in

whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis.

SUMMARY

Infectious Mononucleosis is caused by the Epstein-Barr virus, which is a member of the

herpesvirus family. Symptoms of IM are fever, sore throat and swollen lymph glands. In very

rare cases, heart or central nervous system problems may occur. Diagnosis of IM is made

based on the presence of heterophile antibodies. Infectious mononucleosis heterophile

antibodies belong to the IgM class. They are present in 80-90% of acute IM cases and can be

detected in 60-70% of patients during the first week of clinical illness.

1-4

Infectious Mononucleosis Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes

an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies

in whole blood, serum or plasma in just minutes.

PRINCIPLE

Infectious Mononucleosis Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane

strip based immunoassay for the detection of IM heterophile antibodies in whole blood, serum

or plasma. In this test procedure, bovine erythrocyte extracted antigen is coated on the test line

region of the device. The sample reacts with bovine erythrocyte extracted antigen coated

particles that have been applied to the label pad. This mixture migrates chromatographically

along the length of the test strip and interacts with the coated bovine erythrocyte extracted

antigen. If the sample contains IM antibodies, a colored line will appear in the test line region

indicating a positive result. If the sample does not contain IM heterophile antibodies, a colored

line will not appear in this region indicating a negative result. To serve as a procedural control, a

colored line will always appear at the control line region, indicating that proper volume of

specimen has been added and membrane wicking has occurred.

REAGENTS

The test device contains bovine erythrocyte extracted antigen-coated particles and bovine

erythrocyte extracted antigen-coated membrane.

PRECAUTIONS

• For professional in vitro diagnostic use only. Do not use after expiration date.

• Do not eat, drink or smoke in the area where the specimen samples and kits are handled.

• The positive and negative controls contain human plasma. Handle controls and all specimen

samples as if they contain infectious agents. Observe established precautions against

Package Insert

English

Summary of content (28 pages)

PAGE 1
Package Insert English Infectious Mononucleosis Test Device (Whole Blood/Serum/Plasma) A rapid test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies in whole blood, serum and plasma. For professional in vitro diagnostic use only.
PAGE 2
• • • microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimen samples. The positive and negative controls contain sodium azide as a preservative, which may form potentially explosive metal azide if it reacts with lead or copper plumbing. Large quantities of water should be used to flush discarded controls down a sink. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimen samples are assayed.
PAGE 3
• • • • • • Disposable heparinized capillary tubes and dispensing bulb Positive control (Diluted human plasma containing IM heterophile antibodies, 0.09% sodium azide) Negative control (Diluted human plasma, 0.
PAGE 4
INTERPRETATION OF RESULTS (Please refer to the illustration above) POSITIVE*: Two distinct red lines appear. One line should be in the control line region (C) and another line should be in the test line region (T). A positive result means that IM heterophile antibodies were detected in the sample. *NOTE: The shade of the red color in the test line region (T) will vary based on the amount of IM heterophile antibodies in the sample. Any shade of red in the test line region (T) should be considered positive.
PAGE 5
EXPECTED VALUES Epstein-Barr virus infection during adolescence or young adulthood causes infectious 1,5 mononucleosis 35% to 50% of the time. The incidence of EBV-associated infectious mononucleosis in the USA has been estimated at 45 per 100,000 and is highest in adolescent and young adults- about 2 out of 1,000. No seasonal pattern of EBV infection exists. The incubation period is 10 to 60 days, though 7 to 14 days is common for children and adolescents.
PAGE 6
In addition, the clinical samples were tested with a commercially available rapid diagnostic test kit. 611 serum, plasma and whole blood specimens were used to compare Infectious Mononucleosis Test Device (Whole Blood/Serum/Plasma) to a comparator test. The results showed a >99% agreement between the two test kits. The results for each sample matrix are summarized below.
PAGE 7
Non-Laboratory User Study A total of 77 untrained, inexperienced, non-laboratory participants were enrolled at three separate locations to demonstrate that they could follow the product instructions and perform Infectious Mononucleosis Test Device (Whole Blood/Serum/Plasma) and obtain results similar to those obtained by trained laboratory technicians. Each participant received four blinded spiked whole blood samples: one negative, one invalid, one low positive and one medium positive.
PAGE 8
Prospecto del envase Español Tarjeta de prueba de la mononucleosis infecciosa (para sangre entera, suero o plasma) Prueba rápida para la detección cualitativa en sangre entera, suero o plasma de anticuerpos heterófilos de la mononucleosis infecciosa (MI). Para uso profesional exclusivo para diagnóstico in vitro.
PAGE 9
• Los controles positivo y negativo contienen plasma humano. Los controles y todas las muestras deben manipularse como si contuvieran agentes infecciosos. Observe las precauciones convencionales contra riesgos microbiológicos durante todos los procedimientos y siga el procedimiento habitual para eliminar las muestras correctamente.
PAGE 10
MATERIALES • • • • • • • • • • • • Materiales provistos Tarjetas de prueba Goteros de muestra desechables Tubos capilares heparinizados desechables y perillas dispensadoras Control positivo (plasma humano diluido, con anticuerpos heterófilos de MI; 0.09% de azida sódica) Control negativo (plasma humano diluido; 0.
PAGE 11
INTERPRETACIÓN DE LOS RESULTADOS (Consulte la ilustración anterior) POSITIVO*: Se observan dos líneas rojas definidas. Una línea debe estar en la zona de control (C) y la otra, en la zona de prueba (T). El resultado positivo significa que se detectaron anticuerpos heterófilos de MI en la muestra. *NOTA: El tono del color rojo de la zona de prueba (T) variará en función de la concentración de anticuerpos heterófilos de MI presentes en la muestra.
PAGE 12
4. Como con todas las pruebas para diagnóstico, todos los resultados deben interpretarse junto con el resto de la información clínica que el médico tenga a su disposición. 5. Este análisis no ha sido establecido para pacientes menores de 18 años. VALORES ESPERADOS La infección por el virus de Epstein-Barr durante la adolescencia y juventud es la causa de la mononucleosis infecciosa entre el 35% y el 50% de las veces.
PAGE 13
Además, las muestras clínicas se analizaron con un sistema de prueba para diagnóstico rápido disponible en el mercado. Se emplearon 611 muestras de suero, plasma y sangre entera para comparar la tarjeta de prueba de la mononucleosis infecciosa (para sangre entera, suero o plasma) con un sistema de prueba semejante. Hubo una concordancia >99% entre los resultados de los dos sistemas de prueba. A continuación se resumen los resultados obtenidos para cada matriz de muestras.
PAGE 14
Estudio con usuarios sin capacitación en laboratorio En tres centros diferentes se incorporaron 77 participantes sin capacitación ni experiencia en laboratorio con el fin de demostrar que podían seguir las instrucciones del producto para realizar el análisis con la tarjeta de prueba de la mononucleosis infecciosa (para sangre entera, suero o plasma) y obtener resultados similares a los obtenidos por técnicos de laboratorio capacitados.
PAGE 15
Package Insert English Infectious Mononucleosis Test Device (Whole Blood ONLY) A rapid test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies in whole blood. For professional in vitro diagnostic use only. INTENDED USE The Infectious Mononucleosis Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.
PAGE 16
• • • • The positive and negative controls contain human plasma. Handle controls and all specimen samples as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimen samples. The positive and negative controls contain sodium azide as a preservative, which may form potentially explosive metal azide if it reacts with lead or copper plumbing.
PAGE 17
• • • • Negative control (Diluted human plasma, 0.09% sodium azide) Sample buffer Procedure card Package insert • • • Materials Required But Not Provided Sample collection container (for venipuncture whole blood) Lancet (for fingerstick whole blood only) Timer DIRECTIONS FOR USE Allow the test device, sample, buffer and controls to reach to room temperature (15-30°C) before testing. 1. Remove the test device from the foil pouch and use it as soon as possible.
PAGE 18
*NOTE: The shade of the red color in the test line region (T) will vary based on the amount of IM heterophile antibodies in the sample. Any shade of red in the test line region (T) should be considered positive. NEGATIVE: One red line appears in the control line region (C). No apparent red or pink line appears in the test line region (T). A negative result means that IM heterophile antibodies were not found in the sample or are below the detection limit of the test.
PAGE 19
The incidence of EBV-associated infectious mononucleosis in the USA has been estimated at 45 per 100,000 and is highest in adolescent and young adults- about 2 out of 1,000. No seasonal pattern of EBV infection exists. The incubation period is 10 to 60 days, though 7 to 14 days is common for children and adolescents. PERFORMANCE CHARACTERISTICS A total of 611 clinical samples were tested by three independent sites in a clinical study. Slide agglutination served as the reference method for the study.
PAGE 20
Serum Infectious Mononucleosis Test Device Comparator test + 72 1 + - 0 167 Positive Agreement= 72/73 = 99% (93%-99%)* Negative Agreement= 167/167 > 99% (98%-100%)** Overall Agreement= 239/240 > 99% (98%-99%)* Plasma Infectious Mononucleosis Test Device Comparator test + 59 1 + - 0 180 Positive Agreement= 59/60 = 98% (91%-99%)* Negative Agreement= 180/180 > 99% (98%-100%)** Overall Agreement= 239/240 > 99% (98%-99%)* Whole Blood Infectious Mononucleosis Test Device Comparator test + 50 1 + - 0 80
PAGE 21
Non-Laboratory User Study A total of 77 untrained, inexperienced, non-laboratory participants were enrolled at three separate locations to demonstrate that they could follow the product instructions and perform the Infectious Mononucleosis Test Device (Whole Blood) and obtain results similar to those obtained by trained laboratory technicians. Each participant received four blinded spiked whole blood samples: one negative, one invalid, one low positive and one medium positive.
PAGE 22
Prospecto del envase Español Tarjeta de prueba de la mononucleosis infecciosa (SÓLO para sangre entera) Prueba rápida para la detección cualitativa en sangre entera de anticuerpos heterófilos de la mononucleosis infecciosa (MI). Para uso profesional exclusivo para diagnóstico in vitro.
PAGE 23
PRECAUCIONES • • • • • • Para uso profesional exclusivo para diagnóstico in vitro. No use el producto pasada la fecha de vencimiento. No coma, beba ni fume en el lugar donde se manipulan las muestras y los kits de prueba. Los controles positivo y negativo contienen plasma humano. Los controles y todas las muestras deben manipularse como si contuvieran agentes infecciosos.
PAGE 24
MATERIALES Materiales provistos • • • • • • • • • • • Tarjetas de prueba Goteros de muestra desechables Tubos capilares heparinizados desechables y perillas dispensadoras Control positivo (plasma humano diluido, con anticuerpos heterófilos de MI; 0.09% de azida sódica) Control negativo (plasma humano diluido; 0.
PAGE 25
INTERPRETACIÓN DE LOS RESULTADOS (Consulte la ilustración anterior) POSITIVO*: Se observan dos líneas rojas definidas. Una línea debe estar en la zona de control (C) y la otra, en la zona de prueba (T). El resultado positivo significa que se detectaron anticuerpos heterófilos de MI en la muestra. *NOTA: El tono del color rojo de la zona de prueba (T) variará en función de la concentración de anticuerpos heterófilos de MI presentes en la muestra.
PAGE 26
VALORES ESPERADOS La infección por el virus de Epstein-Barr durante la adolescencia y juventud es la causa de la mononucleosis infecciosa entre el 35% y el 50% de las veces.1,5 Se calcula que la mononucleosis infecciosa asociada al virus de Epstein-Barr tiene una incidencia de 45 por 100,000 en los EE.UU. y que es mayor entre los adolescentes y jóvenes, con aproximadamente 2 casos de cada 1,000 personas. La infección por el virus de EpsteinBarr no sigue un patrón estacional.
PAGE 27
Además, las muestras clínicas se analizaron con un sistema de prueba para diagnóstico rápido disponible en el mercado. Se emplearon 611 muestras de suero, plasma y sangre entera para comparar la tarjeta de prueba de la mononucleosis infecciosa (para sangre entera) con un sistema de prueba semejante. Hubo una concordancia >99% entre los resultados de los dos sistemas de prueba. A continuación se resumen los resultados obtenidos para cada matriz de muestras.
PAGE 28
Estudio con usuarios sin capacitación en laboratorio En tres centros diferentes se incorporaron 77 participantes sin capacitación ni experiencia en laboratorio con el fin de demostrar que podían seguir las instrucciones del producto para realizar el análisis con la tarjeta de prueba de la mononucleosis infecciosa (para sangre entera) y obtener resultados similares a los obtenidos por técnicos de laboratorio capacitados.