Descrizione Clinica
Screenitalia
Mononucleosi tests
Description
Immunochromatographic test for the qualitative identification of the heterophilic antibodies of infectious mononucleosis in whole blood, serum or plasma for assisting the diagnosis of infectious mononucleosis.
In this test, the antigen extracted from cattle erythrocytes is immobilized in the test line area. During the test the sample reacts with the particles covered with antigen extracted from cattle erythrocytes that were applied to the labeled buffer. This mixture migrating chromatographically along the test and interacts with the antigen extracted from immobilized cattle erythrocytes.
If the sample contains heterophile antibodies of infectious mononucleosis, a colored line appears in the test line area, indicating a positive result.
And the sample does not contain heterophilic antibodies of infectious mononucleosis, a colored line will not appear in the test line area indicating a negative result.
As a procedural control, a line always appears in the test control zone indicating that a correct quantity of sample has been added and the membrane reaction took place correctly.
How to use
Collection and preparation of samples
The test can be performed on whole blood samples (from venipuncture or punctured), serum or plasma.
- Whole blood samples from Venipuncture: collect a sample of anti-coagulated blood (sodium or lithium eparin, EDTA of potassium or sodium, sodium oxalate, sodium citrate) following the standard laboratory procedures.
- Full blood samples from Pungidito: Washing the patient's hand with soap and warm water or clean with a wet alcohol knead. Let it dry. Massage your hand without touching the puncture site. Punch the skin with a sterile hand. Remove the first drop of blood blood. Gently massage the hand from the wrist to the palm to the finger to get a round drop of blood. Using a capillary tube collect the blood sample: put the end of the capillary tube into contact with the blood until it fills with about 50 mcl. Avoid the formation of air bubbles.
Separate the serum or plasma from the blood as soon as possible to avoid hemolysis. Use only clear and non-emolised samples.
The test should be done immediately after the samples collection.
Do not leave the samples at room temperature for long periods of time. Serum and plasma samples can be stored at 2-8 ° C up to 3 days.
For long storage, the samples must be stored below -20 ° C.
The whole blood collected for venipuncture should be stored at 2-8 ° C if you intend to take the test within 2 days of the collection. Do not freeze whole blood samples. The whole blood samples obtained with pungidito should be tested immediately.
Bring the samples to room temperature before the test. Frozen samples must be completely thawed and mixed carefully before the test. The samples must not be frozen and thawed repeatedly.
If the samples must be shipped, they must be packed according to local laws regarding the transport of etiological agents.
Test execution
Move the test, sample, buffer and / or control solutions at room temperature (15-30 ° C) before testing.
Remove the test from the sealed package and use it as soon as possible. The best results are obtained if the test is performed within an hour from the opening of the package.
Place the test on a clean and flat surface.
- Serum or plasma samples: Keep the dropper vertically and transfer 1 drop of serum or plasma (about 25 mcl) in the sample cockpit on the test box and 1 drop of buffer (about 55 mcl) and start the timer.
- Whole blood samples from Venipuncture: Keep the dropper vertically and transfer 2 drops of whole blood (about 50 mcl) into the sample cockpit (s) on the test box, then add 1 drop of buffer (about 55 mcl), And start the timer.
- Pungidito whole blood samples: fill the capillary tube with blood sample and transfer about 50 MCL of full blood from punctured into the sample cockpit (s) of the test box, then add 1 drop of buffer (about 55 MCL) and start the timer.
Wait for the appearance of the line / and and colored. Read the results at 5 minutes. Don't interpret the results after 10 minutes.
Results interpretation
Positive: two colored lines appear. A line appears in the control zone (C) and the other appears in the test area (t).
The intensity of the line color in the test area (T) varies depending on the concentration of heterophilic antibodies of infectious mononucleosis present in the sample. Therefore each color gradient in the test line area (t) should be considered positive.
Negative: a colored line appears in the control zone (C). No colored line appears in the test area. (T)
Null: the control line (c) does not appear. The most likely reasons for the failure to appear of the control line (c) are a volume of insufficient sample or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, interrupt the use of the kit immediately and contact your local distributor.
Warnings
Only for in vitro diagnostic use.
Do not use over the expiration date.
The test must remain in the sealed package up to use.
Do not eat, drink or smoke in the manipulation area of samples or kits.
Do not use if the package is damaged.
Manipulate all samples and controls as if they contained infectious agents. Observe the precautions established against the microbiological risk throughout the test course and follow the standard procedures for the appropriate disposal of samples and controls.
The human plasma used in the positive and negative control solution has been tested with Elisa due to the presence of virus antibodies from human immunodeficiency of the HIV-1 / HIV-2 type, as well as for the surface antigen of hepatitis B (HBSAG) and anti-HCV, and found negative. However, pay attention to the manipulation and disposal of solutions.
Wear protective clothing as laboratory gowns, disposable gloves and protective glasses during sample analysis.
Used tests must be disposed of according to local laws.
Humidity and temperature can negatively affect the results.
The test should be used for identifying antibodies of infectious mononucleosis only on whole blood samples, serum or plasma. This qualitative test cannot determine neither the quantitative value nor the rate of increase in the antibodies of infectious mononucleosis.
The test will only indicate the presence of antibodies of infectious mononucleosis in the sample and should not be used as the only criterion for the diagnosis of infection by infectious mononucleosis.
As for all quick tests, all results must be interpreted together with other clinical information available to the doctor.
If the test result is negative and clinical symptoms persist, we recommend additional analysis with other clinical methods. A negative result does not in any way preclude the possibility of an infection from infectious mononucleosis.
Storage
Store packaged in the sealed envelope at room temperature or refrigerated (2-30 ° C). Don't freeze.
The test is stable up to the expiry date printed on the sealed package. The test must remain in the sealed package until use. Do not use over the expiration date.
Valid to packaging intact: 24 months.
Format
25 tests
Cod. Sc-0647-25
Immunochromatographic test for the qualitative identification of the heterophilic antibodies of infectious mononucleosis in whole blood, serum or plasma for assisting the diagnosis of infectious mononucleosis.
In this test, the antigen extracted from cattle erythrocytes is immobilized in the test line area. During the test the sample reacts with the particles covered with antigen extracted from cattle erythrocytes that were applied to the labeled buffer. This mixture migrating chromatographically along the test and interacts with the antigen extracted from immobilized cattle erythrocytes.
If the sample contains heterophile antibodies of infectious mononucleosis, a colored line appears in the test line area, indicating a positive result.
And the sample does not contain heterophilic antibodies of infectious mononucleosis, a colored line will not appear in the test line area indicating a negative result.
As a procedural control, a line always appears in the test control zone indicating that a correct quantity of sample has been added and the membrane reaction took place correctly.
How to use
Collection and preparation of samples
The test can be performed on whole blood samples (from venipuncture or punctured), serum or plasma.
- Whole blood samples from Venipuncture: collect a sample of anti-coagulated blood (sodium or lithium eparin, EDTA of potassium or sodium, sodium oxalate, sodium citrate) following the standard laboratory procedures.
- Full blood samples from Pungidito: Washing the patient's hand with soap and warm water or clean with a wet alcohol knead. Let it dry. Massage your hand without touching the puncture site. Punch the skin with a sterile hand. Remove the first drop of blood blood. Gently massage the hand from the wrist to the palm to the finger to get a round drop of blood. Using a capillary tube collect the blood sample: put the end of the capillary tube into contact with the blood until it fills with about 50 mcl. Avoid the formation of air bubbles.
Separate the serum or plasma from the blood as soon as possible to avoid hemolysis. Use only clear and non-emolised samples.
The test should be done immediately after the samples collection.
Do not leave the samples at room temperature for long periods of time. Serum and plasma samples can be stored at 2-8 ° C up to 3 days.
For long storage, the samples must be stored below -20 ° C.
The whole blood collected for venipuncture should be stored at 2-8 ° C if you intend to take the test within 2 days of the collection. Do not freeze whole blood samples. The whole blood samples obtained with pungidito should be tested immediately.
Bring the samples to room temperature before the test. Frozen samples must be completely thawed and mixed carefully before the test. The samples must not be frozen and thawed repeatedly.
If the samples must be shipped, they must be packed according to local laws regarding the transport of etiological agents.
Test execution
Move the test, sample, buffer and / or control solutions at room temperature (15-30 ° C) before testing.
Remove the test from the sealed package and use it as soon as possible. The best results are obtained if the test is performed within an hour from the opening of the package.
Place the test on a clean and flat surface.
- Serum or plasma samples: Keep the dropper vertically and transfer 1 drop of serum or plasma (about 25 mcl) in the sample cockpit on the test box and 1 drop of buffer (about 55 mcl) and start the timer.
- Whole blood samples from Venipuncture: Keep the dropper vertically and transfer 2 drops of whole blood (about 50 mcl) into the sample cockpit (s) on the test box, then add 1 drop of buffer (about 55 mcl), And start the timer.
- Pungidito whole blood samples: fill the capillary tube with blood sample and transfer about 50 MCL of full blood from punctured into the sample cockpit (s) of the test box, then add 1 drop of buffer (about 55 MCL) and start the timer.
Wait for the appearance of the line / and and colored. Read the results at 5 minutes. Don't interpret the results after 10 minutes.
Results interpretation
Positive: two colored lines appear. A line appears in the control zone (C) and the other appears in the test area (t).
The intensity of the line color in the test area (T) varies depending on the concentration of heterophilic antibodies of infectious mononucleosis present in the sample. Therefore each color gradient in the test line area (t) should be considered positive.
Negative: a colored line appears in the control zone (C). No colored line appears in the test area. (T)
Null: the control line (c) does not appear. The most likely reasons for the failure to appear of the control line (c) are a volume of insufficient sample or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, interrupt the use of the kit immediately and contact your local distributor.
Warnings
Only for in vitro diagnostic use.
Do not use over the expiration date.
The test must remain in the sealed package up to use.
Do not eat, drink or smoke in the manipulation area of samples or kits.
Do not use if the package is damaged.
Manipulate all samples and controls as if they contained infectious agents. Observe the precautions established against the microbiological risk throughout the test course and follow the standard procedures for the appropriate disposal of samples and controls.
The human plasma used in the positive and negative control solution has been tested with Elisa due to the presence of virus antibodies from human immunodeficiency of the HIV-1 / HIV-2 type, as well as for the surface antigen of hepatitis B (HBSAG) and anti-HCV, and found negative. However, pay attention to the manipulation and disposal of solutions.
Wear protective clothing as laboratory gowns, disposable gloves and protective glasses during sample analysis.
Used tests must be disposed of according to local laws.
Humidity and temperature can negatively affect the results.
The test should be used for identifying antibodies of infectious mononucleosis only on whole blood samples, serum or plasma. This qualitative test cannot determine neither the quantitative value nor the rate of increase in the antibodies of infectious mononucleosis.
The test will only indicate the presence of antibodies of infectious mononucleosis in the sample and should not be used as the only criterion for the diagnosis of infection by infectious mononucleosis.
As for all quick tests, all results must be interpreted together with other clinical information available to the doctor.
If the test result is negative and clinical symptoms persist, we recommend additional analysis with other clinical methods. A negative result does not in any way preclude the possibility of an infection from infectious mononucleosis.
Storage
Store packaged in the sealed envelope at room temperature or refrigerated (2-30 ° C). Don't freeze.
The test is stable up to the expiry date printed on the sealed package. The test must remain in the sealed package until use. Do not use over the expiration date.
Valid to packaging intact: 24 months.
Format
25 tests
Cod. Sc-0647-25
