The combined test for the detection of HIV1/2 (HIV1/2), hepatitis C (HCV), hepatitis B (HBsAg), syphilis (TP) is a rapid immunochromatographic assay for the qualitative determination of 4 immune markers, these are: antibodies to HIV1/2 (HIV1 /2), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), and anti-Treponema Pallidum (TP) antibodies in human whole blood/plasma/serum. For in vitro diagnostic use only.
SHORT DESCRIPTION
HIV1/2 (HIV1/2): HIV (human immunodeficiency virus) is the causative agent of AIDS (acquired immunodeficiency syndrome). HIV belongs to the retrovirus family of the lentivirus genus, and is divided into two groups, HIV-1 and HIV-2. HIV-1 is highly mutagenic, and can be divided into 9 subtypes based on membrane protein mutations (A, B, C, D, E, F, G, H, and O). HIV-2 has 60% nucleotides homologous to HIV-1, but they differ in their ability to infect, HIV-1 being the predominant strain of the virus. Once infected, it mutates rapidly and has a poor prognosis. HIV-2 has a longer latent period and is relatively weak in its pathogenesis.
Hepatitis C (HCV): Hepatitis C virus is an RNA virus that is a very active viral pathogen. Infection with the hepatitis C virus occurs despite a healthy immune system. It enters the body through direct contact with the blood. The virus attacks the liver cells where it replicates (replicates). HCV causes liver inflammation and kills liver cells. In 80% ~ 85% of people who are pre-infected with HCV, the infection can become chronic, that is, the infection does not appear within six months. Most people with chronic hepatitis C do not have symptoms. In 10%~25% of people with chronic hepatitis C, the disease progresses over 10~40 years, and can lead to severe liver damage, cirrhosis, and liver cancer.
Hepatitis B (HBV): Hepatitis B virus (HBV) belongs to the hepadnaviridae family and is a DNA virus. Its core contains circular double-stranded DNA and polymerases. Its shell contains lipoproteins. There are five signal proteins in the blood, and they are considered the main serological signs of HBV infection. These include hepatitis B surface antigen (HBsAg); hepatitis B surface antibody (HBsAb), hepatitis B envelope antigen (HBeAg), hepatitis B envelope antibody (HBeAb), and hepatitis B core antibody (HBcAb). This test detects hepatitis B surface antigen (HBsAg).
Syphilis (TP): Syphilis is a curable infection caused by a bacterium called Treponema Pallidum (TP), which is highly infectious. This infection is sexually transmitted and can also be passed from mother to fetus during pregnancy. The disease is spread primarily through sexual transmission or through close contact with a person who has an open, moist syphilitic sore.
SPECIMEN COLLECTION AND PREPARATION
Whole blood collection:
1. Using the standard blood collection procedure, draw a whole blood sample from a vein or fingerstick using a blood collection tube.
2. It is recommended to test samples immediately. Do not leave samples at room temperature for extended periods of time. If samples are not protested immediately, they can be stored at 2°C ~ 8°C. Whole blood samples that have been stored at 2°C ~ 8°C for more than 7 days are not suitable for analysis.
Serum and plasma:
1. Using the standard blood collection procedure, draw a whole blood sample from a vein using a blood collection tube. For plasma collection, use blood collection tubes with an appropriate anticoagulant.
2. Separate serum/plasma as quickly as possible to avoid hemolysis.
3. The test should be performed immediately after sample collection. Do not leave samples at room temperature for extended periods of time. Samples can be stored at 2°C ~ 8°C for up to 3 days. For long-term storage, specimens should be stored below -20°C.
Bring samples to room temperature before testing. Frozen samples must be completely thawed and well mixed before testing. Do not freeze and thaw specimens repeatedly. Only clear, non-hemolyzed specimens may be used.
ANALYSIS PROCEDURE
Before testing, bring the device, buffer, and sample to room temperature (10°C~30°C).
1. Pull out the test device with the foil sachet tearing at the tear line and place it on a horizontal surface.
2. To analyze a whole blood sample:
① While holding the pipette vertically, add two drops of whole blood (approximately 50 µl) to each sample well of the test cassette. ② Add about two drops of the buffer (included in the kit) from the vial directly to each sample well.
To analyze a serum/plasma sample:
Holding the pipette upright, add 3-4 drops (80µl ~ 100µl) of serum or plasma to each sample well (buffer solution is not used).
3. Wait 15 minutes and evaluate the results. Do not interpret test results later than 30 minutes.
INTERPRETATION OF THE RESULTS
Positive (+)
Colored stripes are visualized in both control and test signs. This indicates a positive result.
Negative (-)
The colored strip is visualized only in the control area. The color bar does not appear in the test area. This indicates that the concentration of antibodies/antigens in the sample is zero or below the detection limit of the test.
Invalid
Stripes are absent at all, or a strip appears only in the test area, and is absent in the control area. Repeat the test with a new test set.
LIMITATIONS OF THE PROCEDURE
1. This test has been designed to test whole blood/serum/plasma samples only. The performance of this test with other samples has not been confirmed.
2. As with any diagnostic procedure, confirmation of the diagnosis can only be made after all clinical and laboratory findings have been verified.
3. This test is a qualitative screening test. It is not designed to quantify concentration values.
4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not exclude the possibility of infection.
