SYP Elisa Test Kit
INTENDED USE
The TP Ab ELISA is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of antibodies to
T.pallidum in human serum or plasma. It is intended for screening blood donors and diagnosing patients related to
infection with T.pallidum virus.
Summary
Syphilis is a disease, usually sexually transmitted, caused by infection with the spirochete Treponema pallidum
(T.pallidum). Infection is systemic from the outset and the disease is characterized by periods of latency, often in
excess of twenty years. These features, together with the fact that T. pallidum cannot be isolated in culture mean that
serological techniques play a major role in the diagnosis of syphilis and treatment follow-up. The procedures most
commonly used to screen for antibodies to T. pallidum in clinical diagnostic laboratories are based upon their reaction
with non-treponemal lipoidal antigens (the reagin tests). Reagin tests, such as the RPR or VDRL, can be used to test
serial dilutions of the serum specimen. The end point values from sequentially obtained serum samples decline
following successful treatment until after a period of several months the patient will usually become reagin test
non-reactive. Clinical diagnostic serum specimens which are reactive in reagin tests are typically confirmed using
treponemal tests such as the Microhaemagglutination-T. pallidum (MHA-TP) or the Fluorescent Treponemal
Antibody-Absorption (FTA-ABS) test. In contrast to the non-treponemal tests, treponemal test reactivity will persist
following treatment in approximately 85% of the cases often for the life of the patient. Any sera giving reactive or
equivocal results on initial treponemal based assays must be supplemented with a quantitative non-treponemal test
(such as RPR or VDRL) to distinguish from active disease and assist in ruling out false positives. Donors of blood
and/or plasma for transfusion are screened for T. pallidum antibodies using either reagin or treponemal tests. The
detection of T. pallidum antibodies is used to help identify donors who present an increased risk of transmitting
blood-borne infections. Syphilis-IgG is a treponemal test for T. pallidum IgG class antibodies. The enzyme
immunoassay format allows use of a microplate reader which eliminates subjective interpretation of results and the
test procedure can be automated for high-volume testing
| Product details |
Description |
| Delivery |
Within 48 hours |
| Packaging Specifications |
8 x 12 strips, 96 wells |
| Country Of Origin |
China |
| Manufacturer |
18 months |
| Preservation method |
2℃-8℃ |
| Specimen |
Whole blood |
| Assification |
class1 |
| Type |
SYP Elisa Test Kit |
SPECIMEN COLLECTION, TRANSPORTATION AND STORAGE
1. Specimen Collection: No special patient’s preparation required. Collect the specimen in accordance with the
normal laboratory practice. Either fresh serum or plasma specimens can be used with this assay. Blood collected
by venipuncture should be allowed to clot naturally and completely – the serum/plasma must be separated from
the clot as early as possible as to avoid haemolysis of the RBC. Care should be taken to ensure that the serum
specimens are clear and not contaminated by microorganisms. Any visible particulate matters in the specimen
should be removed by centrifugation at 3000 RPM (round per minutes) for 20 minutes at room temperature or by
filtration.
2.
Plasma specimens collected into EDTA, sodium citrate or heparin can be tested, but highly lipaemic, icteric, or
hemolytic specimens should not be used as they can give false results in the assay. Do not heat inactivate
specimens. This can cause deterioration of the target analyte. Samples with visible microbial contamination
should never be used.
3.
This ELISA kit is intended ONLY for testing of individual serum or plasma samples. Do not use the assay for
testing of cadaver samples, saliva, urine or other body fluids, or pooled (mixed) blood.
4.
Transportation and Storage: Store specimens at 2-8°C. Specimens not required for assaying within 7 days
should be stored frozen (-20°C or lower). Multiple freeze-thaw cycles should be avoided. For shipment, samples
should be packaged and labeled in accordance with the existing local and international regulations for
transportation of clinical samples and ethological agents.
STORAGE AND STABILITY
The components of the kit will remain stable through the expiration date indicated on the label and package when
stored between 2-8°C, do not freeze. To assure maximum performance of this ELISA kit, during storage, protect the
reagents from contamination with microorganism or chemicals.
PRECAUTIONS AND SAFETY
TO BE USED ONLY FROM QUALIFIED PROFESSIONALS
The ELISA assays are time and temperature sensitive. To avoid incorrect result, strictly follow the test procedure
steps and do not modify them.
1.
Do not exchange reagents from different lots or use reagents from other commercially available kits. The
components of the kit are precisely matched for optimal performance of the tests.
2.
Make sure that all reagents are within the validity indicated on the kit box and of the same lot. Never use reagents
beyond their expiry date stated on labels or boxes.
3.
CAUTION - CRITICAL STEP: Allow the reagents and specimens to reach room temperature (18-30°C) before
use. Shake reagent gently before use. Return at 2-8°C immediately after use.
4.
Use only sufficient volume of sample as indicated in the procedure steps. Failure to do so, may cause in low
sensitivity of the assay.
5.
Do not touch the bottom exterior of the wells; fingerprints or scratches may interfere with the reading. When
reading the results, ensure that the plate bottom is dry and there are no air bubbles inside the wells.
6.
Never allow the microplate wells to dry after the washing step. Immediately proceed to the next step. Avoid the
formation of air bubbles when adding the reagents.
7.
Avoid assay steps long time interruptions. Assure same working conditions for all wells.
8.
Calibrate the pipette frequently to assure the accuracy of samples/reagents dispensing. Use different disposal
pipette tips for each specimen and reagents in order to avoid cross-contaminations.
9.
Assure that the incubation temperature is 37°C inside the incubator.
10. When adding specimens, do not touch the well’s bottom with the pipette tip.
11. When measuring with a plate reader, determine the absorbance at 450nm or at 450/630nm.
12. The enzymatic activity of the conjugate might be affected from dust and reactive chemical and substances like
sodium hypochlorite, acids, alkalis etc. Do not perform the assay in the presence of these substances.
13. If using fully automated equipment, during incubation, do not cover the plates with the plate cover. The tapping out
of the remainders inside the plate after washing, can also be omitted.
14. All specimens from human origin should be considered as potentially infectious. Strict adherence to GLP (Good
Laboratory Practice) regulations can ensure the personal safety.
15. WARNING: Materials from human origin may have been used in the preparation of the Negative Control of the kit.
These materials have been tested with tests kits with accepted performance and found negative for antibodies to
HIV 1/2, HCV, TP and HBsAg. However, there is no analytical method that can assure that infectious agents in the
specimens or reagents are completely absent. Therefore, handle reagents and specimens with extreme caution
as if capable of transmitting infectious diseases. Bovine derived sera have been used for stabilizing of the positive
and negative controls. Bovine serum albumin (BSA) and fetal calf sera (FCS) are derived from animals from
BSE/TSE free-geographical areas.
16. Never eat, drink, smoke, or apply cosmetics in the assay laboratory. Never pipette solutions by mouth.
17. Chemical should be handled and disposed of only in accordance with the current GLP (Good Laboratory
Practices) and the local or national regulations.
18. The pipette tips, vials, strips and specimen containers should be collected and autoclaved for not less than 2
hours at 121°C or treated with 10% sodium hypochlorite for 30 minutes to decontaminate before any further steps
of disposal. Solutions containing sodium hypochlorite should NEVER be autoclaved. Materials Safety Data Sheet
(MSDS) available upon request.
19. Some reagents may cause toxicity, irritation, burns or have carcinogenic effect as raw materials. Contact with the
skin and the mucosa should be avoided but not limited to the following reagents: Stop solution, the Chromogens,
and the Wash buffer.
20. The Stop solution 0.5M H is an acid. Use it with appropriate care. Wipe up spills immediately and wash with
water if come into contact with the skin or eyes.
21. ProClin TM 300 0.1% used as preservative, can cause sensation of the skin. Wipe up spills immediately or wash
with water if come into contact with the skin or eyes.
INDICATIONS OF INSTABILITY DETERIORATION OF THE REAGENT: Values of the Positive or Negative controls,
which are out of the indicated quality control range, are indicators of possible deterioration of the reagents and/or
operator or equipment errors. In such case, the results should be considered as invalid and the samples must be
retested. In case of constant erroneous results and proven deterioration or instability of the reagents, immediately
substitute the reagents with new one
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