Accessories:
Instruction for use, pipette
    Principle of Test:
Immunochromatographic assay
    Product Performance:
Sensitivity: 99.35% Specificity: 98.32%

INTENDED USE

The HEV IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis E virus (HEV) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HEV. Any reactive specimen with the HEV IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

TEST PROCEDURE

1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3.Use the 5µl capillary pipette provided,withdraw the specimen to the mark line. Dispense the specimen to “S” well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. / If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Wait for colored lines to appear. Read the results within 15-20 minutes. DO NOT INTERPRET RESULT AFTER 20 MINUTES.

INTERPRETATION OF RESULTS

Positive: Two colored lines appear in the result window, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

Negative: Only the control line appears in the result window.

Invalid: If no line appears in the control region, the test result is invalid regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

  Accessories:
Instruction for use, pipette
  Principle of Test:
Immunochromatographic assay

Specimen: Whole blood/Serum/Plasma

Model NO: B16-22

INTENDED USE

One Step Multi-HBV Test Device is a rapid, qualitative, immunoassay for the determination of HBV Markers (HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb) in human whole blood/serum /plasma in a convenient one step test format. Both the testing and results are intended to be used by medical and forensic professionals only. The test should not be used without appropriate supervision.

TEST PROCEDURE

1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Add 60µl (2 drops) of serum or plasma to each sample well and simultaneously start timing.

4. Add 40µl (1 drop) of buffer if the specimens is whole blood.

5. Read test results after 20 minutes. Do not read test results after 30 minutes.

INTERPRETATION OF RESULTS

(1) HBsAg, HBsAb, HBeAg

Positive: Two colored lines appear in the result window, one in the test region (T) and another one in the control region(C). The result is positive no matter the test line is weaker or stronger than the control line.

Negative: Only one colored line appears in the control region(C).

Invalid: If no line appears in the control region, the test result is invalid regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

(2) HBeAb, HBcAb

Positive：Only one line appears in the control region(C).

Weak positive: One colored line appears in the control region (C) and a weaker colored line appears in the test region (T).

Negative: Two colored lines appear in the result window, one in the control region (C) and another one in the test region (T).

Invalid: If no line appears in the control region, the test result is invalid regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use, pipette
    Principle of Test:
Immunochromatographic assay

 INTENDED USE

The HAV test is a rapid qualitative lateral flow test designed for the qualitative detection of hepatitis A infection (HAV).

  TEST PROCEDURE

1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. According to the proportion of 1:1000, add 4µl of specimen in the 4ml buffer bottle and shake well.

4. Then drop 2 drops (100µl ) of well mixed buffer into the sample well.

5. Read results within 10 minutes.

INTERPRETATION OF RESULTS

Positive: Two pink-colored lines appear in the result window, one in the test region (T) and another one in the control region (C). This indicates that the specimen contains detectable amount of HAV antibody.

Negative: Only one pink-colored line appears in the control region (C) of the result window. This indicates that there is no detectable HAV antibody in the serum specimen.

Invalid: If no line appears in the control region, the test result is invalid regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control  line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

Accessories:
Instruction for use, feces collection tube
Principle of Test:
Immunochromatographic assay
Product Performance：
Rotavirus: Specificity : 99.4%, Sensitivity: 98.4%

Adenovirus:Specificity : 99.2%, Sensitivity: 97.5%

 INTENDED USE

The RV/ADV Antigen Test Device is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of RV/ADV antigen in feces.

Rotavirus (RV) is the primary causative agent of acute gastro-enteritis, especially in children less than 2 years old. Its discovery in 1973 and its association with infantile gastro-enteritis represented a very important advance in the study of gastro-enteritis not caused by acute bacterial infection. Rotavirus is transmitted by oral-faecal contact with an incubation period of 1-3 days etc. In the case of hospitalised children with acute enteritis, up to 50% of the samples examined are rotavirus positive.

The RV/ADV (ADV) is the second most common cause of viral gastro-enteritis in children (10-15%). This virus may also cause respiratory diseases and, depending on the serotype, also diarrhoea, conjunctivitis, cystitis,etc. At least 47 serotypes of RV/ADV have been described, all sharing a common hexon antigen.Serotypes 40 and 41 are the ones associated with gastro-enteritis, whose main symptom is diarrhoea thatmay last between 9 and 12 days associated with temperature and vomits.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open  thepouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Specimen collection. Please see “SPECIMEN COLLECTION AND STORAGE”.
4. Shake the sample collection tube well.
5. Holding the sample collectiontubeupright, carefully unscrew the top cap of collection tube.
6. Squeeze 2drops of the specimen solution in the sample well.
7. Read resultsbetween 5-10 minutes. Do not read the result after 10 minutes.

INTERPRETATION OF RESULTS

Positive: Two distinct red lines appear, one in the test region T1 or T2 and another one in the control region(C),this indicates a positive test result and RV or ADV antigens having been detected.Three distinct red lines appear,this indicates positive test result and RV and ADV antigens having been detected.

Negative: Only one red line appears in the control region(C). This indicates a negative test results and no RV/ADV antigens having been detected.

Invalid: If the control line fails to appear, the test result is invalid regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, please contact your local distributor.

Accessories:  Sterile Swabs,Processing tubes,Test tube tips,Buffer solution,Instruction for use

Principle of Test:Immunochromatographic assay
Product Performance:Sensitivity: 1 X 10⁵ IFU/mL

Model No: C50-20

INTENDED USE

One Step T.V Ag test is used for the qualitative determination of Trichomonas vaginalis antigen from vaginal swabs.This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen.

SPECIMEN COLLECTION

1.Quality of testing specimen is crucial. Sufficient microorganism in the swabs should be guaranteed.

2.Collect the vaginal secretions from vaginal posterior dome using sterile swab.In absence of speculum, long swabs can also be used to collect the specimen from vaginal.

3.Put the swab into the sample tube if the specimen is to be tested immediately. If not, keep the specimen in a dry tube.The specimen can be stored for 72 hours at 2-8℃. For longer storage, specimen should be frozen at -20℃. Avoid freezing and thawing repeatedly.

4.Specimen processing:Add 20 drops of buffer vertically into the sample processing tube. Put the swab with specimen into the tube and rotate for 10 seconds to mix the reagents. After swallowing the sample in the tube for 2 minutes, wipe the swab along the tube wall, remove excess liquid and discard the swab. Cover the dipping tip of the processing tube.

TEST PROCEDURE

 The specimen,test kit and other testing materials should be brought and equillibrated to room temperature（15-30℃） prior to use.  Remove the test cassette from the pouch and use it as soon as possible.

Place the cassette on a clean surface. Make sure the tip of processing tube points downwards, squeeze the tube wall and add 2-3 drops of specimen into the sample well of the test cassette.

Wait for the pink colored lines to appear.Read result between 15-30 minutes. Do not read result after 30 minutes.

INTERPRETATION OF RESULTS

Positive

Two pink-colored lines appear in the result window,one is the test line, and the other is the control line. The color intensity of the test line may be weaker or stronger than that of the control line.

Negative

Only one pink colored line appears in the control region.No apparent pink line appears in the test region.

Invalid

Control line fails to appear. If the control line does not form, the test result is invalid and the assay should be repeated with a new device.

  Accessories:
Instruction for use, feces collection tube
Principle of Test:
Immunochromatographic assay
Product Performance：
Sensitivity: 97.48%

INTENDED USE

One Step MP-IgM test is used to qualitatively detect the existence of MP -IgM antibodies in serum or plasma sample, as an auxiliary diagnostic reagent of MP infection in clinic.

TEST PROCEDURE

1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop (10ul)of serum/plasma to the sample well.
4. Hold the buffer bottle vertically and add 1 drop (40ul)to the sample well. / If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2drops of buffer to the sample well.
5. Wait for colored lines to appear. Read result between 15-20 minutes.The observation is invalid after 20 minutes.

INTERPRETATION OF RESULTS

Positive: Two colored lines appear in the result window, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

Negative: Only the control line appears in the result window.

Invalid: If no line appears in the control region, the test result is invalid regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

  Accessories:
Chasing buffer, sterile lancet, alcohol pre pad, pipette, bandage
  Principle of Test:
Immunochromatographic assay
Product Performance:
Sensitivity: 99.40%

INTENDED USE: This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in whole blood, serum or plasma specimens. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HIV and for screening of blood donors, or blood products as well.

TEST PROCEDURE
1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
CAUTION: The above interpreting time is based on room temperature range of 15 – 30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS
NEGATIVE: The presence of only one line in the control region indicates a negative result (Figure 1).

HIV-1 Positive: The control line and HIV-1 line (T1) are visible in the result window. The test is positive for HIV-1.
HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result window. The test is positive for HIV-2.
HIV-1 and HIV-2 Positive: The control line, HIV-1 (T1) and HIV-2 (T2) lines are visible in the result window. The test is positive for HIV-1and HIV-2.

Regarding the positive results for both HIV-1 and HIV-2 in one patient, it is possible for reasons as follows：
1. There is the homology in the amino acid sequence of HIV type-1 and type-2. So, it is possible that the test results show the positive results for HIV-1 and HIV-2 in one patient, simultaneously.
2. Provisionally, you can conclude virus type according to the line density. If the line density of type-1 is darker than that of type-2 in the result window, you can read as HIV-1 positive. If the line density of type-2 is darker than that of type-1 in the result window, you can read as HIV-2 positive. If you want to determine virus type or co-infection exactly, you should perform the confirmatory assay (e.g Western blot etc.).

INVALID: If the pink color line in C region is not visible, the result is considered invalid (Figure 3)
regardless of the presence or absence of the test line(s).

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

Accessories:
Chasing buffer, sterile lancet, pipette, instruction for use
Principle of Test:
Immunochromatographic assay
Product Performance:
Sensitivity: 99.40%

INTENDED USE: This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in whole blood, serum or plasma specimens. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HIV and for screening of blood donors, or blood products as well.

TEST PROCEDURE
1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.Caution: The above interpreting time is based on room temperature range of 15 – 30°C. If your room temperature is
significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS
Negative: The presence of only one line in the control region indicates a negative result (Figure 1).

HIV-1 Positive: The control line and HIV-1 line (T1) are visible in the result window. The test is positive for HIV-1.
HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result window. The test is positive for HIV-2.
HIV-1 and HIV-2 Positive: The control line, HIV-1 (T1) and HIV-2 (T2) lines are visible in the result window. The test is positive for HIV-1and HIV-2.

Regarding the positive results for both HIV-1 and HIV-2 in one patient, it is possible for reasons as follows：
1. There is the homology in the amino acid sequence of HIV type-1 and type-2. So, it is possible that the test results show the positive results for HIV-1 and HIV-2 in one patient, simultaneously.
2. Provisionally, you can conclude virus type according to the line density. If the line density of type-1 is darker than that of type-2 in the result window, you can read as HIV-1 positive. If the line density of type-2 is darker than that of type-1 in the result window, you can read as HIV-2 positive. If you want to determine virus type or co-infection exactly, you should perform the confirmatory assay (e.g Western blot etc.).
Invalid: If the pink color line in C region is not visible, the result is considered invalid (Figure 3) regardless of the presence or absence of the test line(s).

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

Accessories:
  Chasing buffer, sterile lancet, pipette, instruction for use 
  Principle of Test:
  Immunochromatographic assay
  Product Performance:
  Sensitivity: 99.40%

INTENDED USE: This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in whole blood, serum or plasma specimens. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HIV and for screening of blood donors, or blood products as well.

TEST PROCEDURE
1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay. 
2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Hold the dropper vertically and transfer 1 drop of WB/ Serum/Plasma to the sample pad of the test strip. Then hold the buffer bottle vertically and add 1 drop and start the timer.
4. Wait for the red line to appear. Read result between 10-20 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

Negative: The presence of only one line in the control region indicates a negative result (Figure 1).

HIV-1 Positive: The control line and HIV-1 line (T1) are visible in the result area. The test is positive for HIV-1.

HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result area. The test is positive for HIV-2.

HIV-1 and HIV-2Positive: The control line, HIV-1 (T1) and HIV-2 (T2) lines are visible in the result area. The test is positive for HIV-1 and HIV-2.

Regarding the positive results for both HIV-1 and HIV-2 in one patient, it is possible for reasons as follows：

1. There is the homology in the amino acid sequence of HIV type-1 and type-2. So, it is possible that the test results show the positive results for HIV-1 and HIV-2 in one patient, simultaneously.

2. Provisionally, you can conclude virus type according to the line density. If the line density of type-1 is darker than that of type-2 in the result area, you can read as HIV-1 positive. If the line density of type-2 is darker than that of type-1 in the result window, you can read as HIV-2 positive. If you want to determine virus type or coinfection exactly, you should perform the confirmatory assay (e.g Western blot etc.).

Invalid: If the pink color line in C region is not visible, the result is considered invalid (Figure 3) regardless of the presence or absence of the test line(s).

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new strip. If problem persists, please contact your local distributor.

Accessories:
  Chasing buffer, pipette, instruction for use 
  Principle of Test:
  Immunochromatographic assay
  Product Performance:
  Sensitivity: 99.40%

INTENDED USE: This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in serum or plasma specimens. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HIV and for screening of blood donors, or blood products as well.

TEST PROCEDURE
1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay. 
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well. 
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
Caution: The above interpreting time is based on room temperature range of 15 – 30°C. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS
Negative: The presence of only one line in the control region indicates a negative result (Figure 1).

HIV-1 Positive: The control line and HIV-1 line (T1) are visible in the result window. The test is positive for HIV-1. 
HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result window. The test is positive for HIV-2. 
HIV-1 and HIV-2 Positive: The control line, HIV-1 (T1) and HIV-2 (T2) lines are visible in the result window. The test is positive for HIV-1and HIV-2.

Regarding the positive results for both HIV-1 and HIV-2 in one patient, it is possible for reasons as follows： 
1. There is the homology in the amino acid sequence of HIV type-1 and type-2. So, it is possible that the test results show the positive results for HIV-1 and HIV-2 in one patient, simultaneously.
2. Provisionally, you can conclude virus type according to the line density. If the line density of type-1 is darker than that of type-2 in the result window, you can read as HIV-1 positive. If the line density of type-2 is darker than that of type-1 in the result window, you can read as HIV-2 positive. If you want to determine virus type or co-infection exactly, you should perform the confirmatory assay (e.g Western blot etc.).

Invalid: If the pink color line in C region is not visible, the result is considered invalid (Figure 3) regardless of the presence or absence of the test line(s).

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

  Accessories:
Chasing buffer, pipette, instruction for use
  Principle of Test:
Immunochromatographic assay
  Product Performance:
Sensitivity: 99.40%

INTENDED USE: This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in serum or plasma specimens. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HIV and for screening of blood donors, or blood products as well.

TEST PROCEDURE
1.Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.
2.Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.
3.Hold the dropper vertically and transfer 2 drops of serum or plasma to the sample pad of the test strip. Then hold the buffer bottle vertically and add 1 drop and start the timer.
4.Wait for the red line to appear. Read result between 10-20 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS  
Negative: The presence of only one line in the control region indicates a negative result (Figure 1).

HIV-1 Positive: The control line and HIV-1 line (T1) are visible in the result area. The test is positive for HIV-1.
HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result area. The test is positive for HIV-2.
HIV-1 and HIV-2Positive: The control line, HIV-1 (T1) and HIV-2 (T2) lines are visible in the result area. The test is positive for HIV-1 and HIV-2.

Regarding the positive results for both HIV-1 and HIV-2 in one patient, it is possible for reasons as follows：
1. There is the homology in the amino acid sequence of HIV type-1 and type-2. So, it is possible that the test results show the positive results for HIV-1 and HIV-2 in one patient, simultaneously.
2. Provisionally, you can conclude virus type according to the line density. If the line density of type-1 is darker than that of type-2 in the result area, you can read as HIV-1 positive. If the line density of type-2 is darker than that of type-1 in the result window, you can read as HIV-2 positive. If you want to determine virus type or coinfection exactly, you should perform the confirmatory assay (e.g Western blot etc.).
Invalid: If the pink color line in C region is not visible, the result is considered invalid (Figure 3) regardless of the presence or absence of the test line(s).

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new strip. If problem persists, please contact your local distributor.

    Accessories:
    Instruction for use, pipette,buffer
Principle of Test:
    Immunochromatographic assay
Production Performance:
    Specificity: 94.3%

INTENDED USE: The TB Test Device is a chromatographic immunoassay (CIA) for direct qualitative detection of tuberculosis antibody in human serum or plasma.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3.Use the pipette to draw and slowly add 1 drop of serum/plasma to the sample well.

4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15 – 30°C. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

POSITIVE:

Two pink lines appear in the result window. This indicates that the specimen contains detectable amount of TB antibody.

NEGATIVE:

Only one pink line appears in test region of the result window. This indicates that there is no detectable TB antibody in the specimen.

INVALID:

No line appears in the control region regardless of the presence or absence of the line in the test region.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use, pipette,buffer,sterile lancet
    Principle of Test:
Immunochromatographic assay
    Production Performance:
Specificity: 94.3%

INTENDED USE: The TB Test Device is a chromatographic immunoassay (CIA) for direct qualitative
detection of tuberculosis antibody in human whole blood, serum or plasma.

TEST PROCEDURE

1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Hold the dropper vertically and transfer 1 drop of WB/Serum/Plasma to the sample pad of the test strip. Then hold the buffer bottle vertically and add 1 drop and start the timer.

4. Wait for the red line to appear. Read the result between 10-20minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE:

Two red lines are visible in the result area. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

NEGATIVE:

The control line appears in the result area, but the test line is not visible.

INVALID:

If the control line does not appear in the result area, the test results are INVALID regardless of the presence or absence of the line in the test region.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new strip. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use, pipette,buffer
    Principle of Test:
Immunochromatographic assay
    Production Performance:
Specificity: 94.3%

INTENDED USE: The TB Test Device is a chromatographic immunoassay (CIA) for direct qualitative detection of tuberculosis antibody in human serum or plasma.

TEST PROCEDURE

1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to withdraw specimen and dispense 1 drop onto the sample pad.

4. Hold the buffer bottle vertically and dispense 1 drop to the sample pad. A separate test strip must be for each  specimen or control.

5. Wait for colored lines to appear. Read between 10-20 minutes. Do not interpret result after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15 – 30°C. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

POSITIVE:

Two colored lines appear in the result area, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

NEGATIVE:

Only one colored line appears in test region of the result area.

INVALID:

No line appears in the control region regardless of the presence or absence of the line in the test region.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new strip. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use, pipette,buffer,sterile lancet
    Principle of Test:
Immunochromatographic assay
    Production Performance:
Specificity: 94.3%

INTENDED USE: The TB Test Device is a chromatographic immunoassay (CIA) for direct qualitative detection of tuberculosis antibody in human whole blood, serum or plasma.

TEST PROCEDURE
1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3.Use the pipette to draw and slowly add 1 drop of whole blood to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15 – 30°C. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

POSITIVE:
Two pink lines appear in the result window. This indicates that the specimen contains detectable amount of TB antibody.

NEGATIVE:
Only one pink line appears in test region of the result window. This indicates that there is no detectable TB antibody in the specimen.

INVALID:
No line appears in the control region regardless of the presence or absence of the line in the test region.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control  line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use, feces collection tube
    Principle of Test:
Immunochromatographic assay

INTENDED USE: The H.Pylori Ag Test Device is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of Helicobacter Pylori antigen in feces.

SPECIMEN COLLECTION AND STORAGE

1. Collect stool specimen by using the sample collection tube provided.

2. Unscrew the top of the sample collection tube, take out the sample collection stick, and collect the specimen by dipping the stick into 3 different places of the feces.

3. Replace the specimen collection stick in the tube and screw tightly.

4. If the specimen cannot be tested on the day of collection, store the feces specimen at 4°C. Bring the specimen to room temperature before testing.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Specimen collection. Please see also SPECIMEN COLLECTION

4. Shake the sample collection tube well.

5. Holding the sample collection device upright, carefully twist off the tip of collection tube.

6. Squeeze 2-3 drops of the specimen solution in the sample well.

7.   Wait for the colored line(s) to appear. The result should be read within 15 minutes. Do  not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

Positive

Two distinct pink-colored lines appear, one in the test region (T) and one in the control region(C).

Negative

Only one pink-colored line appears in the control region(C).

Invalid

Control Line fails to appear regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, please contact your local distributor.

Accessories:
Instruction for use, pipette,buffer
Principle of Test:
Immunochromatographic assay
Production Performance:
Accuracy: 98.7%

INTENDED USE: The H. Pylori Antibody Test is a chromatographic immunoassay (CIA) for the rapid determination of antibodies of H. Pylori in serum or plasma specimens. The test is used as an aid in the diagnosis of infection due to H. Pylori.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid  cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

Positive:

Two pink lines appear in the result window. This indicates that the specimen contains detectable amount of  H. Pylori antibody.

Negative:

Only one pink line appears in the control region (C). This indicates that there is no detectable H. Pylori antibody in specimen.

Invalid:

No colored line appears in the control region regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use, pipette,buffer, sterile lancet
Principle of Test:
Immunochromatographic assay
Production Performance:
    Accuracy: 98.7%

INTENDED USE: The H. Pylori Antibody Test is a chromatographic immunoassay (CIA) for the rapid determination of antibodies of H. Pylori in whole blood, serum or plasma specimens. The test is used as an aid in the diagnosis of infection due to H. Pylori.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

Positive:

Two pink lines appear in the result window. This indicates that the specimen contains detectable amount of H. Pylori antibody.

Negative:

Only one pink line appears in the control region (C). This indicates that there is no detectable H. Pylori antibody in specimen.

Invalid:

No colored line appears in the control region regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use, pipette, buffer, sterile lancet
Principle of Test:
    Immunochromatographic assay
Product Performance:
    Sensitivity: 97.9%     specificity: 97.9%

INTENDED USE: One Step HCV Test is a rapid and convenient immunochromatographic assay for qualitative detection of antibodies to Hepatitis C Virus (HCV) in human serum or plasma. It is intended for professional use as an aid in diagnosis of HCV infection. This test is a screening test and provides only a preliminary result. All positive results should be confirmed using clinical expertise and professional judgments.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette packed in the pouch to draw and slowly add 1 drop of whole blood specimen to the sample well. Hold the buffer bottle vertically and add 1 drop to the sample well. / If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

4. Wait for 10-15 minutes and read results. Do not read results after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive               Negative                   Invalid

Positive:
Two colored lines should be observed in the result window, one in the test region and another one in the
control region.
Negative:
Only the control line appears in the result window.
Invalid:
No line appears in the control region regardless of the presence or absence of the line in the test region.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use, pipette
    Principle of Test:
Immunochromatographic assay
    Product Performance:
Sensitivity: 97.9%     specificity: 97.9%

INTENDED USE: One Step HCV Test is a rapid and convenient immunochromatographic assay for qualitative detection of antibodies to Hepatitis C Virus (HCV) in human serum or plasma. It is intended for professional use as an aid in diagnosis of HCV infection. This test is a screening test and provides only a preliminary result. All positive results should be confirmed using clinical expertise and professional judgments.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and add 2 drops of serum/plasma specimen to the sample well.

4. Wait for 10-15 minutes and read results. Do not read results after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room

temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive             Negative                Invalid

Positive:
Two colored lines should be observed in the result window, one in the test region and another one in the
control region.
Negative:
Only the control line appears in the result window.
Invalid:
No line appears in the control region regardless of the presence or absence of the line in the test region.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for
the control  line failure. Review the procedure and repeat the test with a new device. If problem persists,
please contact your local distributor.

    Accessories:
Instruction for use, pipette
    Principle of Test:
Immunochromatographic assay
Product Performance:
Sensitivity: 97.9%     specificity: 97.9%

INTENDED USE: One Step HCV Test is a rapid and convenient immunochromatographic assay for qualitative detection of antibodies to Hepatitis C Virus (HCV) in human serum or plasma. It is intended for professional use as an aid in diagnosis of HCV infection. This test is a screening test and provides only a preliminary result. All positive results should be confirmed using clinical expertise and professional judgments.

TEST PROCEDURE

1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.

2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Immerse the test strip in the specimen with the arrow end pointing toward the specimen solution. Do not immerse the strip above the printed MAX line. After a minimum of 15 seconds, remove the test strip from the specimen solution and lay flat on a nonabsorptive clean surface. Alternatively, the test strip may be left in the test specimen as long as the strip is not immersed above the MAX line. A separate test strip must be for each specimen or control.

4. Wait for colored lines to appear. Read results within 10-15 minutes. Do not interpret results after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15 – 30℃. If your room

temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two colored lines should be observed in the viewing area, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

Negative:

Only control line appears.

Invalid:

No line appears in the control region regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new strip. If problem persists, please contact your local distributor.

  Accessories:
Instruction for use, buffer, sterile lancet, pipette
  Principle of Test:
Immunochromatographic assay
  Product Performance:
Sensitivity: 99.20%

INTENDED USE: One Step Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis.

TEST PROCEDURE

1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Hold the dropper vertically and transfer 1 drop of Whole Blood to the sample pad of the test strip. Then hold the buffer bottle vertically and add 1 drop and start the timer.

4. Wait for the red line to appear. Read the result between 10-20minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

Positive

Two red lines are visible in the result area. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

Negative

The control line appears in the result area, but the test line is not visible.

Invalid

If the control line does not appear in the result area, the test results are INVALID regardless of the presence or absence of the line in the test region.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new strip. If problem persists, please contact your local distributor.

Accessories:
Instruction for use, buffer, sterile lancet, pipette
Principle of Test:
Immunochromatographic assay
Product Performance:
Sensitivity: 99.20%

Intended Use:One Step Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use
    Principle of Test:
Immunochromatographic assay
    Product Performance:
Sensitivity: 99.20%

INTENDED USE: One Step Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis.

TEST PROCEDURE

1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Immerse the test strip in the specimen with the arrow end pointing toward the specimen solution. Do not immerse the strip above the printed MAX line. After a minimum of 15 seconds, remove the test strip from the specimen solution and lay flat on a nonabsorptive clean surface. Alternatively, the test strip may be left in the test specimen as long as the strip is not immersed above the MAX line. A separate test strip must be for each specimen or control.

4. Wait for the red line to appear. Read result between 10-20 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

Positive

Two red lines are visible in the result area. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

Negative

The control line appears in the result area, but the test line is not visible.

Invalid

If the control line does not appear in the result area, the test results are INVALID regardless of the presence or absence of the line in the test region.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new strip. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use
    Principle of Test:
Immunochromatographic assay
    Product Performance:
Sensitivity: 99.20%

INTENDED USE: One Step Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

    Accessories:
Instruction for use, pipette, buffer, sterile lancet
    Principle of Test:
Immunochromatographic assay
    Product Performance:
Sensitivity: 10mIU/ml   Accuracy: >99%

INTENDED USE: Hepatitis B Surface Antibody Test is a rapid, immunochromatographic assay for the detection of antibodies to Hepatitis B surface antigen (HBsAb) in human whole blood,serum or plasma. The test provides a visual, qualitative result and is intended for professional use.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Dispense 2 drops of the specimen or control into the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops to the sample well.

5. Wait for the colored lines to appear. Interpret results between 15-20 minutes. Do not interpret results after 20 minutes.

INTERPRETATION OF RESULTS

Positive:

Two colored lines should be observed in the result window, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

Negative:

Only the control line appears in the result window.

Invalid:

No line appears in the control region regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

Accessories:
Instruction for use, pipette, buffer, sterile lancet
Principle of Test:
Immunochromatographic assay
Product Performance:
Sensitivity: 10mIU/ml   Accuracy: >99%

INTENDED USE: Hepatitis B Surface Antibody Test is a rapid, immunochromatographic assay for the detection of antibodies to Hepatitis B surface antigen (HBsAb)in whole blood, human serum or plasma. The test provides a visual, qualitative result and is intended for professional use.

TEST PROCEDURE
1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.
2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to slowly draw and add 2 drops of whole blood to the sample pad, then hold the buffer bottle vertically and add 1 drop of buffer.
4. Wait for colored lines to appear. Interpret test results between 15-20 minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

Positive:
Two colored lines should be observed in the result area, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.
Negative:
Only the control line appears in the result area.
Invalid:
No line appears in the control region regardless of the presence or absence of the test line.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the controlline failure. Review the procedure and repeat the test with a new test strip. If problem persists, please contact yourlocal distributor.

    Accessories:
Instruction for use, pipette
    Principle of Test:
Immunochromatographic assay
    Product Performance:
Sensitivity: 10mIU/ml   Accuracy: >99%

INTENDED USE: Hepatitis B Surface Antibody Test is a rapid, immunochromatographic assay for the detection of antibodies to Hepatitis B surface antigen (HBsAb)in human serum or plasma. The test provides a visual,qualitative result and is intended for professional use.

TEST PROCEDURE

1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Immerse the test strip in the specimen with the arrow end pointing toward the specimen solution. Do not immerse the strip above the printed MAX line. After a minimum of 15 seconds, remove the test strip from the specimen solution and lay flat on a non-absorptive clean surface. Alternatively, the test strip may be left in the

test specimen as long as the strip is not immersed above the MAX line. A separate test strip must be for each specimen or control.

4. Wait for colored lines to appear. Interpret test results between 15-20 minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

Positive               Negative                   Invalid

Positive:Two colored lines should be observed in the result area, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

Negative:Only the control line appears in the result area.

Invalid: No line appears in the control region regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new test strip. If problem persists, please contact your local distributor.

Accessories:
Instruction for use, pipette
    Principle of Test:
Immunochromatographic assay
    Product Performance:
Sensitivity: 10mIU/ml   Accuracy: >99%

INTENDED USE: Hepatitis B Surface Antibody Test is a rapid, immunochromatographic assay for the detection of antibodies to Hepatitis B surface antigen (HBsAb)in human serum or plasma. The test provides a visual, qualitative result and is intended for professional use.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready

to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Dispense 3 drops of the specimen or control into the sample well.

4. Wait for colored lines to appear. Interpret test results between 15-20 minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

Positive: Two colored lines should be observed in the result window, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

Negative:Only the control line appears in the result window.

Invalid: No line appears in the control region regardless of the presence or absence of the test line.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.