 |
HCV Rapid Test Device
Package Insert
Specimens: Whole Blood/Serum/Plasma
Effective Date: 2015‐ 02
For professional in vitro diagnostic use only.
INTENDED USE
The HCV Rapid Test Device (Whole Blood /Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HCV in human whole blood, serum or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HCV infection.
Hepatitis C Virus (HCV) is a small, enveloped, positive‐sense, single‐stranded RNA Virus.
HCV is now known to be the major cause of parenterally transmitted non‐A, non‐B hepatitis. Antibody to HCV is found in over 80% of patients with well‐documented non‐A, non‐B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross‐reactivity and to increase the sensitivity of the HCV antibody tests.
The HCV Rapid Test Device (Whole Blood /Serum/Plasma) has been designed to detect antibodies to HCV through visual interpretation of color development in the internal strip. The membrane was immobilized with protein A on the test region. During the test, the specimen is allowed to react with colored recombinant HCV antigens colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interacts with reagents on the membrane. If there were enough HCV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
Each device contains a strip with colored conjugates
Individually packed test devices
Disposable pipettes
Buffer
Package insert For operation instruction.
Specimen collection container For specimens collection use.
Lancets for fingerstick whole blood only
Disposable heparinized capillary for fingerstick whole blood only
tubes and dispensing bulb
Timer For timing use.
Centrifuge For preparation of clear specimens
For professional in vitro diagnostic use only.
Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is
damaged. Do not reuse tests.
This kit contains products of animal origin. Certified knowledge of the origin and/or
sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
Avoid cross‐contamination of specimens by using a new specimen collection container for
each specimen obtained.
Read the entire procedure carefully prior to performing any tests.
Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle
all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
Do not interchange or mix reagents from different lots.
Humidity and temperature can adversely affect results.
The used testing materials should be discarded in accordance with local, state and/or federal
regulations.
STORAGE AND STABILITY
The kit should be stored at 2‐30°C until the expiry date printed on the sealedpouch. 
The test must remain in the sealed pouch until use.
Do not freeze.
Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of
dispensing equipments, containers or reagents can lead to false results.
SPECIMEN COLLECTION AND STORAGE
The HCV Rapid Test device (Whole Blood/Serum/ Plasma) can be performed using whole blood
(from venipuncture or fingerstick), serum, or plasma.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
Add the Fingersitck Whole Blood specimen to the test device by using a capillarytube: 
Touch the end of the capillary tube to the blood until filled to approximately 50 
l.
Avoid air bubbles.
Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense
the whole blood onto the specimen well (S) of the test device.
Add the Fingersitck Whole Blood specimen to the test device by using hangingdrop: 
Position the patient’s finger so that the drop of blood is just above the specimen well
(S) of the test device.
Allow 2 hanging drops of fingerstick whole blood to fall onto the specimen well (S) of the test device, or move the patient’s finger so that the hanging drop touches the specimen well (S). Avoid touching the finger directly to the specimen well (S).
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear,
non‐hemolyzed specimens.
Testing should be performed immediately after specimen collection. Do not leave the specimens
at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2‐ 8°C for up to 3 days. For long term storage, specimens should be kept below ‐20°C. Whole blood collected by venipuncture should be stored at 2‐8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed
and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
If specimens are to be shipped, they should be packed in compliance with federal regulations covering
the transportation ofetiologic agents.
Bring tests, specimens, buffer and/or controls to room temperature (15‐30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2. For Serum or Plasma specimen: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 
l) and 1 drop buffer to the specimen well (S) of the test device, and start the timer.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of venipuncture whole blood (approximately 50 
l) to the specimen well (S) of the test device, then
add 2 drops of buffer and start the timer.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50 
l of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 2 drops of buffer and start thetimer.
To use hanging drop: Allow 2 hanging drop of fingerstick whole blood specimen (approximately 50 
l) to fall into the center of the specimen well (S) on the test device, then add 2 dropsof buffer and start the timer.
3. Wait for the red line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
C T NEGATIVE RESULT: C T INVALID RESULT: C T | * A colored band appears in the control band region (C) and another colored band appears in the T band region. One colored band appears in the control band region (C). No band appears in the test band region (T). Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. |
NOTE:
1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.
QUALITY CONTROL
Internal procedural controls are included in the test. A colored band appearing in the control
region (C) is considered an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique.
External controls are not supplied with this kit. It is recommended that positive and negative
controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
LIMITATIONS OF THE TEST
1. The HCV Rapid Test Device (Whole Blood /Serum/Plasma) is for professional in vitro diagnostic use, and should be used for the qualitative detection of antibodies to HCVonly.
2. The HCV Rapid Test Device (Whole Blood /Serum/Plasma) will only indicate the presence of HCV antibodies in the specimen and should not be used as the sole criteria for the diagnosis of HCV viral infection.
3. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at anytime rule out the existence of HCV antibodies in blood, because antibodies may be absent or below the minimum detection level of the test.
4. Like with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all
clinical and laboratory findings have been evaluated. Table: HCV Rapid Test vs. EIA HCV Rapid T + 2 | Total 565 2544 3109 |
1. Choo, Q.L., G. Kuo, A.J. Weiner, L.R. Overby, D.W. Bradley, and M. Houghton. Isolation of a cDNA clone derived from a blood‐borne non‐A, non‐B viral hepatitis genome. Science 1989; 244:359
2. Kuo, G., Q.L. Choo, H.J. Alter, and M. Houghton. An assay for circulating antibodies to a major etiologic Virus of human non‐A, non‐B hepatitis. Science 1989;244:362
3. van der Poel, C. L., H.T.M. Cuypers, H.W. Reesink, and P.N.Lelie. Confirmation of hepatitis C Virus infection by new four‐antigen recombinant immunoblot assay.
4. Lancet 1991; 337:317Wilber, J.C. Development and use of laboratory tests for hepatitis C infection: a review. J. Clin. Immunoassay 1993; 16:204
HCV Rapid Test Device
Package Insert
Specimens: Whole Blood/Serum/Plasma
Effective Date: 2015‐ 02
For professional in vitro diagnostic use only.
INTENDED USE
The HCV Rapid Test Device (Whole Blood /Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HCV in human whole blood, serum or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HCV infection.
Hepatitis C Virus (HCV) is a small, enveloped, positive‐sense, single‐stranded RNA Virus.
HCV is now known to be the major cause of parenterally transmitted non‐A, non‐B hepatitis. Antibody to HCV is found in over 80% of patients with well‐documented non‐A, non‐B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross‐reactivity and to increase the sensitivity of the HCV antibody tests.
The HCV Rapid Test Device (Whole Blood /Serum/Plasma) has been designed to detect antibodies to HCV through visual interpretation of color development in the internal strip. The membrane was immobilized with protein A on the test region. During the test, the specimen is allowed to react with colored recombinant HCV antigens colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interacts with reagents on the membrane. If there were enough HCV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
Each device contains a strip with colored conjugates
Individually packed test devices
Disposable pipettes
Buffer
Package insert For operation instruction.
Specimen collection container For specimens collection use.
Lancets for fingerstick whole blood only
Disposable heparinized capillary for fingerstick whole blood only
tubes and dispensing bulb
Timer For timing use.
Centrifuge For preparation of clear specimens
For professional in vitro diagnostic use only.
Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is
damaged. Do not reuse tests.
This kit contains products of animal origin. Certified knowledge of the origin and/or
sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
Avoid cross‐contamination of specimens by using a new specimen collection container for
each specimen obtained.
Read the entire procedure carefully prior to performing any tests.
Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle
all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
Do not interchange or mix reagents from different lots.
Humidity and temperature can adversely affect results.
The used testing materials should be discarded in accordance with local, state and/or federal
regulations.
STORAGE AND STABILITY
The kit should be stored at 2‐30°C until the expiry date printed on the sealedpouch. The test must remain in the sealed pouch until use.
Do not freeze.
Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of
dispensing equipments, containers or reagents can lead to false results.
SPECIMEN COLLECTION AND STORAGE
The HCV Rapid Test device (Whole Blood/Serum/ Plasma) can be performed using whole blood
(from venipuncture or fingerstick), serum, or plasma.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
Add the Fingersitck Whole Blood specimen to the test device by using a capillarytube: Touch the end of the capillary tube to the blood until filled to approximately 50 l.
Avoid air bubbles.
Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense
the whole blood onto the specimen well (S) of the test device.
Add the Fingersitck Whole Blood specimen to the test device by using hangingdrop: Position the patient’s finger so that the drop of blood is just above the specimen well
(S) of the test device.
Allow 2 hanging drops of fingerstick whole blood to fall onto the specimen well (S) of the test device, or move the patient’s finger so that the hanging drop touches the specimen well (S). Avoid touching the finger directly to the specimen well (S).
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear,
non‐hemolyzed specimens.
Testing should be performed immediately after specimen collection. Do not leave the specimens
at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2‐ 8°C for up to 3 days. For long term storage, specimens should be kept below ‐20°C. Whole blood collected by venipuncture should be stored at 2‐8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed
and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
If specimens are to be shipped, they should be packed in compliance with federal regulations covering
the transportation ofetiologic agents.
Bring tests, specimens, buffer and/or controls to room temperature (15‐30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2. For Serum or Plasma specimen: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 l) and 1 drop buffer to the specimen well (S) of the test device, and start the timer.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of venipuncture whole blood (approximately 50 l) to the specimen well (S) of the test device, then
add 2 drops of buffer and start the timer.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50 l of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 2 drops of buffer and start thetimer.
To use hanging drop: Allow 2 hanging drop of fingerstick whole blood specimen (approximately 50 l) to fall into the center of the specimen well (S) on the test device, then add 2 dropsof buffer and start the timer.
3. Wait for the red line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
C T NEGATIVE RESULT: C T INVALID RESULT: C T | * A colored band appears in the control band region (C) and another colored band appears in the T band region. One colored band appears in the control band region (C). No band appears in the test band region (T). Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. |
NOTE:
1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.
QUALITY CONTROL
Internal procedural controls are included in the test. A colored band appearing in the control
region (C) is considered an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique.
External controls are not supplied with this kit. It is recommended that positive and negative
controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
LIMITATIONS OF THE TEST
1. The HCV Rapid Test Device (Whole Blood /Serum/Plasma) is for professional in vitro diagnostic use, and should be used for the qualitative detection of antibodies to HCVonly.
2. The HCV Rapid Test Device (Whole Blood /Serum/Plasma) will only indicate the presence of HCV antibodies in the specimen and should not be used as the sole criteria for the diagnosis of HCV viral infection.
3. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at anytime rule out the existence of HCV antibodies in blood, because antibodies may be absent or below the minimum detection level of the test.
4. Like with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all
clinical and laboratory findings have been evaluated. Table: HCV Rapid Test vs. EIA HCV Rapid T + 2 | Total 565 2544 3109 |
1. Choo, Q.L., G. Kuo, A.J. Weiner, L.R. Overby, D.W. Bradley, and M. Houghton. Isolation of a cDNA clone derived from a blood‐borne non‐A, non‐B viral hepatitis genome. Science 1989; 244:359
2. Kuo, G., Q.L. Choo, H.J. Alter, and M. Houghton. An assay for circulating antibodies to a major etiologic Virus of human non‐A, non‐B hepatitis. Science 1989;244:362
3. van der Poel, C. L., H.T.M. Cuypers, H.W. Reesink, and P.N.Lelie. Confirmation of hepatitis C Virus infection by new four‐antigen recombinant immunoblot assay.
4. Lancet 1991; 337:317Wilber, J.C. Development and use of laboratory tests for hepatitis C infection: a review. J. Clin. Immunoassay 1993; 16:204
POSITIVE RESULT: