Serum/Plasma LIMITATIONS

HCV Ab Rapid Test • Serum and plasma samples may be stored at 2-8°C for 7 days prior to assay, and at -20°C
Package Insert for a long time. • This reagent is designed for the qualitative screening test. Concentration of HCV cannot be
• Frozen and refrigerated samples should be equilibrated to room temperature before determined by this qualitative test.
detection and thoroughly mixed. • The results of the reagent are only for clinical reference, which is not the only basis for
REF VIHC-401/VIHC-402 English
• Avoid repeated freeze-thaw, Samples that exhibiting visible precipitates, stink or muddy clinical diagnosis and treatment. A confirmed diagnosis and treatment should only be made
should not be used. by a physician after all clinical and laboratory findings have been evaluated.
INTENDED USE Whole Blood • Negative result may occur when detecting short-term infected samples, indicate that the
• Whole blood samples with anticoagulants may be stored at 2-8°C for 72 hours, and should specific antibodies of HCV does not exist or the concentration is below detection limit.
The VivaDiagTM HCV Ab Rapid Test is a rapid chromatographic immunoassay for the qualitative be used immediately without anticoagulants. DO NOT FREEZE. Mix the sample well by • Positive results of the patients who used to receive blood transfusions or other blood
detection of Hepatitis C Virus Antibody in human whole blood, serum or plasma. It is intended to gentle inversion of the tube immediately before testing. products therapy, should be analyzed cautiously.
be used as a screening test and as an aid in the diagnosis of infection with HCV. For in vitro • Abnormal results may occur according to operator error or drug use. If HCV infection is still
diagnostic use only. TEST PROCEDURE suspected, the sample should be collected later and carry the parallel detection with the first
Please read the instructions carefully before testing. Allow equipment, buffers, and samples to sample.
SUMMARY
equilibrate to room temperature (15°C to 30°C) prior to testing.
HCV is a single-stranded positive sense RNA virus, which belongs to the family of Flaviviridae. PERFORMANCE
Hepatitis C caused by HCV is an infectious disease with liver as a target organ. The incubation [For Strip]
1. Remove the test strip from the sealed pouch, place it on a clean and level surface with the 1. Accuracy
period of hepatitis C virus infection was 2 to 26 weeks, most of the symptoms occur in 5 to 12
sample adding area up. A clinical evaluation was conducted on 1158 samples comparing the results obtained using the
weeks after transfusion, on an average of 7.4 weeks. There is a long window period with an
2. Using the dropper, vertically transfer 1 drop (approx. 25 µL) of serum/plasma/whole blood HCV Ab Rapid Test and other ELISA HCV test. Comparison for all subjects is showed in the
average of 70 days after the hepatitis C virus infection, however, some patients’ window period
sample into the specimen pad of the test strip, avoiding the formation of bubbles. Add 2 table below:
can be extended to 6~9 months or even longer. Hepatitis C virus antibody can be detected in
most infections with a slow appearance. Generally positive results may occur 2~6 months after drops (approx. 80-100 µL) of sample buffer onto the sample adding area of the strip.
3. Wait for the red line(s) to appear. Read results at 10-20 minutes. Do not interpret results ELISA
the attack, while some positive results occur 12 months later. VivaDiag™ HCV Ab Rapid Test
after 20 minutes.
Positive Negative Total
PRINCIPLE
Positive 391 6 397
The VivaDiag™ HCV Ab Rapid Test is a lateral flow chromatographic immunoassay. The test
strip/device consists of: 1) a burgundy colored conjugate pad containing recombinant protein Negative 2 759 761
mixed HCV antigen conjugated with colloidal gold (antibody conjugates). 2) a nitrocellulose 1 drop 2 drops
membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated Total 393 765 1158
with HCV antigen, and the C line is pre-coated with goat anti-mouse IgG antibody.
During testing, the sample reacts with the particle coated with recombinant protein mixed HCV Sensitivity 99.5%(391/393, 95%CI, 98.2%~99.9%)
antigen. The mixture migrates upward on the membrane chromatographically by capillary
action to react with HCV antigen on the membrane and generate a colored line. Specificity 99.2%(759/765, 95%CI, 98.3%~99.7%)
When the concentration of HCV Ab in the sample to be tested is lower than the critical value, [For Device]
test line weaker than the control line or no red line appears in the Test line, and the test result is 1. Take out a test device from sealed foil pouch and put it on a clean and level surface. Accuracy 99.7%(1150/1158, 95%CI, 98.6%~99.7%)
negative. When the HCV Ab concentration in the sample is at or above the critical value, the 2. Using the dropper, vertically transfer 1 drop (approx. 25 µL) of serum/plasma/whole blood
test line is equal to or stronger than the control line, and the test result is positive. No matter sample into the specimen well (S) of the device, avoiding the formation of bubbles, then 2. Interferences
whether the samples contain HCV Ab or not, a colored line will always appear at the control add 2 drops (approx. 80-100 µL) of sample buffer. 1000 umol/L bilirubin, 5.65 mmol/L triglyceride, 6.5 g/L hemoglobin has no effect on the
line(C) region if the test has been performed properly. 3. Wait for the red line(s) to appear. Read results at 10-20 minutes. Do not interpret results detection result. The reagent is not affected by the rheumatoid factor, antinuclear antibodies.
after 20 minutes. 3. Cross-Reactivity
WARNINGS AND PRECAUTIONS
The HCV Ab Rapid Test is not affected by Hepatitis B surface antigen, hepatitis B e antigen,
• For professional in vitro diagnostic use only. hepatitis B core antibody are simultaneously positive samples, hepatitis B surface antigen,
• Do not use after the expiration date. hepatitis B e antibody, hepatitis B core antibody simultaneously positive samples, TP antibody,
• The test result is invalid over 20 minutes. 1 drop 2 drops HIV antibody.
• The strength of the quality control line doesn’t indicate the quality problem of the reagent, a INDEX OF SYMBOLS
test result that is clearly visible demonstrates the reagent is effective.
• All samples and reagents should be considered potentially hazardous and handled in the
same manner as an infectious agent after use. Consult instructions for Contains sufficient
Use by
• Do not use other kinds of quality control sample to test the reagent. Components of different use for <n> tests
batches cannot be exchanged for use to avoid erroneous results. For in vitro diagnostic
INTERPRETATION OF TEST RESULTS Lot number REF Catalog number
use only
COMPOSITION 30OC Storage temperature
Manufacturer Do not reuse
Materials provided and available for purchase: 2O C limitations
1. Test Strip/Device(dropper) in foil pouch
2. Buffer
3. Package insert
Materials required but not provided:
1. Specimen collection container
2. Centrifuge (for serum/plasma samples) Positive Negative Invalid
3. Timer
Positive*: Two distinct colored lines appear. One line should be in the control line region (C)
4. Personal protective equipment, such as protective gloves, medical masks, lab coats, etc.
and another line should be in the test line region (T).
5. Appropriate biohazardous waste containers and disinfectants.
*Note: The intensity of the color in the test line region (T) may vary depending on the
STORAGE AND HANDLING concentration of HCV Ab present in the specimen. Therefore, any shade of color in the test line
• Store the test kit in a cool, dry place between 36-86°F (2-30°C). Keep away from light. region (T) should be considered positive.
Exposure to temperature and/or humidity outside the specified conditions may cause Negative: One colored line appears in the control line region (C). No apparent colored line
inaccurate results. appears in the test line region (T).
• Do not freeze. Use the test kit at temperatures between 59-86°F (15-30°C).
• Use the test kit between 10-90% humidity. Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural
• Do not use the test kit beyond the expiration date (printed on the foil pouch and box). techniques are the most likely reasons for control line failure. Review the procedure and repeat
Note: All expiration dates are printed in Year-Month-Day format. 2022-06-18 indicates June 18, the test using a new test panel. If the problem persists, discontinue using the lot immediately
2022. and contact your local distributor.

SPECIMEN COLLECTION AND HANDLING QUALITY CONTROL

The HCV Ab Rapid Test can be performed using serum, plasma or whole blood. A procedural control is included in the test. A colored line appearing in the control line region(C)
is considered an internal procedural control. It confirms sufficient specimen volume, adequate
Serum, plasma and whole blood samples must be collected in a clean and dry container. EDTA, membrane wicking and correct procedural technique. Control standards are not supplied with
sodium citrate, heparin can be used as the anticoagulants. Recommend to detect immediately Number: 1624015302
this kit; however, it is recommended that positive and negative controls be tested as a good Effective date: 2024-01-29
after collecting blood. If blood coagulation occurs, serum sample is suggested to use. laboratory practice to confirm the test procedure and to verify proper test performance.