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PRECAUTIONS The test devices must remain sealed in its pouch until use and must not be used

after the marked expiry date.

Chlamydia Test Kit


This kit provides a rapid test for the qualitative detection of antibodies to Chlamydia trachomatis on cervical or urethral swab samples. The test is intended for home use. REAGENTS AND MATERIALS PROVIDED 1. One foil pouch containing test device cassette, a dropper, and a package of desiccant 2. Extraction solution A (0.2M NaCI) 3. Extraction solution B (0.2M HCI) 4. Sterile Dacron-Tipped Swabs 5. Extraction Tube 6. These test Instructions INSTRUCTIONS: 1) Remove the test device from its foil pouch and allow to reach room temperature. Use the test as soon as possible, but within one hour of opening. Place the test device on a clean and level surface 2) A swab is used to obtain a clinical sample from the cervix (female) or urethra (male) as appropriate. Male patients: Swab discharge from the opening of the urinary tract. If no infection is present, insert the swab 2-4cm into the urinary tract, gently move a few turns, and retrieve the swab. Female patients: Swab discharge from the vaginal opening, then insert swab into vagina for half a minute then retrieve swab. 3) Add 6 drops of Extraction Solution A into the extraction tube and then insert the swab. Rotate the swab in the solution and squeeze it against the tube wall for 2 minutes. Then add 6 drops of Extraction Solution B to the tube. Squeeze the swab firmly against the tube to expel as much liquid as possible from swab for a further 1 minute. Discard swab. 4) Using the dropper, transfer 3 drops (approximately 60-90 mm3) of extract into the specimen well of the test device and start the timer. Wait for the rose-pink line (s) to appear. The result should be read at 10 minutes, but must not be read if more than 15 minutes has elapsed since testing.

Test results should be read within 15 minutes once the specimen has been placed in the test well. Our Chlamydia Rapid Tests are limited to the qualitative detection of Tp antibodies in whole human blood, serum or plasma. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. As with all diagnostic tests, results must be interpreted together with other clinical information available to the physician. NEGATIVE RESULT: If only the C band has developed the test indicates that no detectable Chlamydia antibodies are present in the specimen. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of Chlamydia antibodies in the specimen. Positive tests must be confirmed by a qualified medical practitioner. INVALID: If no control band has developed, the essay is invalid regardless of color development on the test band as indicated above. Repeat the assay with a new kit. NOTE: The intensity of the color in the test region (T) varies with the concentration of Chlamydia antibodies present in the specimen. Therefore, any detectable color in the test region should be considered positive. A false negative result can occur if the quantity of the antibodies to Chlamydia present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected. A negative result for an individual subject indicates absence of detectable antibodies to Chlamydia at the time of testing, but does not completely preclude the possibility of infection with the disease. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC.

Syphilis (Tp) Test Kit


This kit provides a rapid test for the qualitative detection of antibodies to syphilis (Treponema palladium (Tp) in human whole blood (WB), serum (S) or plasma (P). The test is intended for home use. TEST PRINCIPLE Our Syphilis (Tp) Combo (WB/S/P) test cassette comprises 1) a pink colored conjugate pad containing anti-Tp antibodies conjugated with colloid gold (Tp conjugated) and rabbit lgG-gold, 2) a nitrocellulose membrane strip containing test and control bands. The T band is coated with non- conjugated Tp antibodies whereas the C band is coated with goat anti-rabbit lgG. The sample is dispensed into the test cassette sample well and migrates by capillary action. If the virus is present in the sample it will move across the conjugated pad under capillary action. The immune-complex is then captured on the membrane, forming a pink rose-colored T band, indicating a positive test result. If the T band does not form, the test is negative. The test contains an internal control (C band) that develops a pink rose-colored band if the test is functioning properly. If no C band forms, the test result is invalid and the specimen must be re-tested with another kit. REAGENTS AND MATERIALS PROVIDED 1. Test devices are individually sealed in a foil pouch with a cassette, a dropper, and a package of desiccant 2. One package insert 3. One fingertip pinprick blood lancet and alcohol swab 4. These test Instructions Instructions: 1. Once removed from the foil pouch, the test device should be allowed to reach room temperature and used as soon as possible, but within one hour of opening. 2. Place the test device on a clean and level surface.

3. Use the lancet provided to prick the thumb and obtain a blood sample. Using the dropper provided, suck the blood sample obtained into the dropper tube up to the marked line. 4. Hold the dropper vertically and transfer 2-3 drops (approximately 60-90 mm3) of blood into the specimen well of the test device and start the timer. 5. Wait for the rose-pink line (S) to appear. The result should be read at 10-15 minutes, but must not be read if more than 20 minutes has elapsed since testing.

TEST LIMITATIONS 1. Our (Tp) Combo (WB/P/S) Rapid Tests are limited to the qualitative detection of Tp antibodies in whole human blood, serum or plasma. 2. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. 3. As with all diagnostic tests results must be interpreted together with other clinical information available to the physician. 4. A false negative result can occur if the quantity of the antibodies to Tp present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected. 5. A negative result of an individual subject indicates absence of detectable antibodies to syphilis at the time of testing, but does not completely preclude the possibility of infection with the disease. INTENDED USE Our Syphilis Rapid Tests detects Tp antibodies to the syphilis virus in human blood, serum or plasma. Any positive results identified with this technique must be confirmed using alternative method(s). PRECAUTIONS 1. The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date. 2. Test results should be read within 20 minutes once the specimen has been placed in the test well. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC. SUMMARY The Std tests R Us Syphilis (Tp) kit permits the detection of antibodies to syphilis. The test is able to detect antibodies during both the active and dormant phases of the disease. This test is intended for home use. Positive tests must be confirmed by a qualified medical practitioner.

1. NEGATIVE RESULT: If only the C band has developed, the test indicates that no detectable Tp antibodies are present in the specimen. 2. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of Tp antibodies in the specimen. Positive results should be confirmed with alternative testing method(s) and on the basis of clinical observations before a positive diagnosis is made. *NOTE: The intensity of the color in the test region (T) varies with the concentration of Tp antibodies present in the specimen. Therefore, any detectable color in the test region should be considered positive. 3. INVALID: If no C band has developed, the assay is invalid regardless of color development on the T band as indicated above. Repeat the assay with a new kit.

Hepatitis B Test Kit


This kit provides a rapid test for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human whole blood (WB), serum (S) or plasma (P). The test is intended for home use. TEST PRINCIPLE Our HBV HBsAg Combo (WB/S/P) test cassette comprises 1) a pink colored conjugate pad containing anti-Tp antibodies conjugated with colloid gold (Tp conjugated) and rabbit lgG-gold, 2) a nitrocellulose membrane strip containing test and control bands. The T band is coated with non- conjugated Tp antibodies whereas the C band is coated with goat anti-rabbit lgG. The sample is dispensed into the test cassette sample well and migrates by capillary action. If the virus is present in the sample it will move across the conjugated pad under capillary action. The immune-complex is then captured on the membrane, forming a pink rose-colored T band, indicating a positive test result. If the T band does not form, the test is negative. The test contains an internal control (C band) that develops a pink rose-colored band if the test is functioning properly. If no C band forms, the test result is invalid and the specimen must be re-tested with another kit. REAGENTS AND MATERIALS PROVIDED 1. Test devices are individually sealed in a foil pouch with a cassette, a dropper, and a package of desiccant 2. One package insert 3. One fingertip pinprick blood lancet and alcohol swab 4. One bottle of buffer 5. These test Instructions Instructions: 1. Once removed from the foil pouch, the test device should be allowed to reach room temperature and used as soon as possible, but within one hour of opening. 2. Place the test device on a clean and level surface.

3. Use the lancet provided to prick the thumb and obtain a blood sample. Using the dropper provided, suck the blood sample obtained into the dropper tube up to the marked line. 4. Hold the dropper vertically and transfer 2-3 drops (approximately 60-90 mm3) of blood into the S well of the cassette and immediately add 1-2 drops of the specimen buffer into the S well too. 5. Depending on the blood concentration of HbsAg, positive result may be observed in as little as 60 seconds. The result should be read at 10 minutes, but must not be read if more than 20 minutes has elapsed since testing

TEST LIMITATIONS 1. Our HBsAg (WB/P/S) Rapid Test is limited to the qualitative detection of HBsAg in whole human blood, serum or plasma 2. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. 3. As with all diagnostic tests results must be interpreted together with other clinical information available to the physician 4. A false negative result can occur if the quantity of the antibodies to hepatitis B virus (HBV) present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected 5. A negative result of an individual subject indicates absence of detectable antibodies to HBV at the time of testing, but does not completely preclude the possibility of infection with HBV. INTENDED USE Our HBsAg Rapid Test detects HBsAg antibodies to Hepatitis B in human blood, serum or plasma. Any positive results identified with this technique must be confirmed using alternative method(s).

1. NEGATIVE RESULT: If only the C band has developed, the test indicates that no detectable HBsAg antibodies are present in the specimen 2. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of HBsAg antibodies in the specimen. Positive results should be confirmed with alternative testing methods (s) and on the basis of clinical observations before a positive diagnosis is made. *NOTE: The intensity of the color in the test region (T) varies with the concentration of HBsAg antibodies present in the specimen. Therefore, any detectable color in the test region should be considered positive. 3. INVALID: If no C band has developed, the assay is invalid regardless of color development on the T band as indicated above. Repeat the assay with a new kit.

PRECAUTIONS 1. The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date. 2. Test results should be read within 15 minutes once the specimen has been placed in the test well. 3. Negative results must be allowed to develop for 30 minutes to ensure that the kit is functioning correctly. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC. SUMMARY Hepatitis B virus affects the liver and is transmitted by sexual activity; blood borne exposure, and other routes. It causes liver damage including acute self-limiting infection, fulminating hepatitis and chronic carrier state. The Std Tests R Us HBsAg kit permits the detection of HBsAg which appears 1-7 weeks before liver jaundice can be detected. Positive tests must be confirmed by a qualified medical practitioner.

Hepatitis C Test Kit


This kit provides a rapid test for the qualitative detection of Hepatitis C surface antigen in human whole blood (WB), serum (S) or plasma (P). The test is intended for home use. TEST PRINCIPLE Our HCV (WB/S/P) test cassette comprises 1) a pink colored conjugate pad containing anti-Tp antibodies conjugated with colloid gold (Tp conjugated) and rabbit lgG-gold, 2) a nitrocellulose membrane strip containing test and control bands. The T band is coated with non- conjugated Tp antibodies whereas the C band is coated with goat anti-rabbit lgG. The sample is dispensed into the test cassette sample well and migrates by capillary action. If the virus is present in the sample it will move across the conjugated pad under capillary action. The immune-complex is then captured on the membrane, forming a pink rose-colored T band, indicating a positive test result. If the T band does not form, the test is negative. The test contains an internal control (C band) that develops a pink rose-colored band if the test is functioning properly. If no C band forms, the test result is invalid and the specimen must be re-tested with another kit. REAGENTS AND MATERIALS PROVIDED 1. Test devices are individually sealed in a foil pouch with a cassette, a dropper, and a package of desiccant, 2. One package insert 3. One fingertip pinprick blood lancet and alcohol swab 4. These test Instructions Instructions: 1. Once removed from the foil pouch, the test device should be allowed to reach room temperature and used as soon as possible, but within one hour of opening. 2. Place the test device on a clean and level surface.

3. Use the lancet provided to prick the thumb and obtain a blood sample. Using the dropper provided, suck the blood sample obtained into the dropper tube up to the marked line. 4. Hold the dropper vertically and transfer 2-3 drops (approximately 60-90 mm3) of blood into the S well of the cassette and immediately add 1-2 drops of the specimen buffer into the S well too. 5. Depending on the blood concentration of HCV, positive result may be observed in as little as 60 seconds. The result should be read at 10 minutes, but must not be read if more than 20 minutes has elapsed since testing.

TEST LIMITATIONS 1. Our HCV (WB/P/S) Rapid Test is limited to the qualitative detection of HCV in whole human blood, serum or plasma 2. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. 3. As with all diagnostic tests results must be interpreted together with other clinical information available to the physician 4. A false negative result can occur if the quantity of the antibodies to hepatitis C virus (HCV) present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected 5. A negative result of an individual subject indicates absence of detectable antibodies to HCV at the time of testing, but does not completely preclude the possibility of infection with HCV. INTENDED USE Our HCV Rapid Test detects HCV antibodies to Hepatitis C in human blood, serum or plasma. Any positive results identified with this technique must be confirmed using alternative method(s).

1. NEGATIVE RESULT: If only the C band has developed, the test indicates that no detectable HCV antibodies are present in the specimen. 2. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of HCV antibodies in the specimen. Positive results should be confirmed with alternative testing methods (s) and on the basis of clinical observations before a positive diagnosis is made. *NOTE: The intensity of the color in the test region (T) varies with the concentration of HCV antibodies present in the specimen. Therefore, any detectable color in the test region should be considered positive. 3. INVALID: If no C band has developed, the assay is invalid regardless of color development on the T band as indicated above. Repeat the assay with a new kit.

PRECAUTIONS 1. The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date. 2. Test results should be read within 15 minutes once the specimen has been placed in the test well. 3. Negative results must be allowed to develop for 30 minutes to ensure that the kit is functioning correctly. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC. SUMMARY Hepatitis C virus affects the liver and is transmitted by sexual activity; blood borne exposure, and other routes. It causes liver damage including acute self-limiting infection, fulminating hepatitis and chronic carrier state. The Std Tests R Us HCV kit permits the detection of HCV which appears 1-7 weeks before liver jaundice can be detected. Positive tests must be confirmed by a qualified medical practitioner.

HIV (Type 1 and 2) Test Kit


This kit provides a rapid test for the qualitative detection of antibodies to the type 1 and 2 human immunodeficiency virus in human whole blood (WB), serum (S) or plasma (P). REAGENTS AND MATERIALS PROVIDED 1. One foil pouch containing test device cassette, a dropper, and a package of desiccant. 2. One fingertip pinprick blood lancet and alcohol swab 3. Butter solution. 4. These test instructions. INSTRUCTIONS 1. Once remove from the foil pouch, the test device should be allowed to reach room temperature and used as soon as possible, but within one hour of opening. 2. Place the test device on a clean and level surface. 3. Use and lancet provided to prick the thumb and obtain a blood sample. Using the dropper provided suck the blood sample obtained into the dropper tube up to the marked line. 4. Hold the dropper vertically and transfer 1 drop (approximately 30-60 mm3) of blood into the specimen well of the test device, add 2 drops of the buffer solution and start the timer. 5. Wait for the rose-pink line(s) to appear. The result should be read at 10 minutes, but must not be read if more than 15 minutes has elapsed since testing.

The Std Tests R Us HIV (WB/P/S) Rapid Test is limited to the qualitative detection of HIV antibodies in whole human blood, serum or plasma. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. As with all diagnostic tests, results must be interpreted together with other clinical information. A false negative result can occur if the quantity of HIV antibodies present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected. A negative result for an individual subject indicates absence of detectable antibodies to HIV at the time of testing, but does not completely preclude the possibility of infection. STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC. NEGATIVE RESULT: If only the C band has developed, the test indicates that no detectable HIV antibodies are present in the specimen. POSTIVE RESULT: If both C and T bands have developed, the test indicates the presence of HIV antibodies in the specimen. *NOTE: The intensity of the color in the test region (T) varies with the concentration of HIV antibodies present in the specimen. Therefore, any detectable color in the test region should be considered as a positive result. INVALID: If no C band has developed, the essay is invalid regardless of color development on the T band as indicated below. Repeat the assay with a new kit. PRECAUTIONS The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date. Test results should be read within 15 minutes once the specimen has been placed in the test well. TEST DETAILS The Std Tests R Us HIV (Type 1 and 2) (WB/P/S) test cassette comprises 1) a pink colored conjugate pad containing anti-HIV antibodies conjugated with colloid gold (HIV conjugated) and rabbit lgG-gold, 2) a nitrocellulose membrane strip containing test and control bands. The T band is coated with non-conjugated Tp antibodies whereas the C band is coated with goat anti-rabbit lgG. The sample is dispensed into the test cassette sample well and migrates by capillary action. If the virus is present in the specimen, antibodies present in the sample will move across the conjugate pad under capillary action. The immune-complex is then captured on the membrane, forming a pink rose-colored T band, indicating a positive test result. If the T band does not form, the test is negative. The test contains an internal control (C band) that develops a pink rose-colored band if the test is functioning properly. If no C band forms, the test result is invalid and the specimen must be re-tested with another kit. SUMMARY The Human immunodeficiency virus (Type 1 and 2) are enveloped, single strain RNA positive viruses. HIV infection may lead to Acquired Immuno-deficiency disease (AIDS) The Std Tests R Us HIV (Type 1 and 2) Rapid Test (WB/P/S) is a rapid test that qualitatively detects the presence of antibodies to HIV 1 and/or HIV 2 in whole blood, serum or plasma. Positive tests must be confirmed by a qualified medical practitioner.

INTERPRETATION OF TEST RESULTS

PRECAUTIONS The test devices must remain sealed in its pouch until use and must not be used after the marked expiry date.

Gonorrhea Test Kit


This kit provides a rapid test for the qualitative detection of antibodies to Gonorrhea on cervical or urethral swab samples. The test is intended for home use. REAGENTS AND MATERIALS PROVIDED 1. One foil pouch containing test device cassette, a dropper, and a package of desiccant 2. Extraction solution A 3. Extraction solution B 4. Sterile Cotton Swab 5. Extraction Tube 6. These test Instructions INSTRUCTIONS: 1. A swab is used to obtain a clinical sample from the cervix (female) or urethra (male) as appropriate. Male patients: Swab discharge from the opening of the urinary tract. If no infection is present, insert the swab 2-4cm into the urinary tract, gently move a few turns, and retrieve the swab. Female patients: Swab discharge from the vaginal opening, then insert swab into vagina for half a minute then retrieve swab. 2. Add 6 drops of Extraction Solution A into the extraction tube and then insert the swab. Rotate the swab in the solution and squeeze it against the tube wall for 2 minutes. Then add 2 drops of Extraction Solution B to the tube. Squeeze the swab firmly against the tube to expel as much liquid as possible from swab for a further 1 minute. Discard swab. 3. Dip the test strip with the arrow pointing down into the specimen for about 5-10 sec. Do Not immerse past the marker max line. As the test begins to work, you will see color move across the membrane. 4. Remove the strip from the solution and let it rest on a clean dry surface. Wait for the colored band(s) to appear. The result should be read at 10-20 minutes. Do not interpret the result after 30 minutes.

Test results should be read within 15 minutes once the specimen has been placed in the test well. The Std Tests R Us Gonorrhea Rapid Test is limited to the qualitative detection of Neisseria Gonorrhoeae in whole human blood, serum or plasma. Failure to follow the assay procedure or test result interpretation correctly may give inaccurate results. As with all diagnostic tests, results must be interpreted together with other clinical information available to the physician A false negative result can occur if the quantity of the antibodies to Gonorrhea present in the specimen is below the detection limit of the assay or the antibodies that are detected are not present during the stage of disease in which a sample is collected A negative result for an individual subject indicates absence of detectable antibodies to Gonorrhea at the time of testing, but does not completely preclude the possibility of infection with the disease STORAGE AND STABILITY Keep the test kit unopened, preferably at 2-8 oC until use. Do not freeze the kit or expose it to temperatures above 30 oC.

NEGATIVE RESULT: If only one colored band appears (the control band) the test indicates that no detectable Neisseria Gonorrhea antibodies are present in the specimen. POSTIVE RESULT: If a second pink band appears (two bands), the test indicates the presence of Neisseria Gonorrhea antibodies in the specimen. INVALID: If no control band has developed, the essay is Invalid regardless of color development on the test band as indicated above. Repeat the assay with a new kit TEST PRINCIPLE The sample is dispensed into the test cassette sample well and migrates by capillary action. If the virus is present in the specimen, antibodies (IgG, IgM, or IgA) present in the sample will move across the conjugate pad under capillary action. The immunocomplex is then captured on the membrane, forming a pink rosecolored T band, indicating a positive test result. If the T band does not form, the test is negative. The test contains an internal control (C band) that develops a pink rose-colored band if the test is functioning properly. If no C band forms, the test result is invalid and the specimen must be re-tested with another kit.

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