Total PSA iFlash

Immunoassay Analyzer

is instrument-specifically generated by 3-point

REF C86000 2×50 Tests 0123 calibration and a master curve provided via the
reagent QR code.
INTENDED USE
REAGENTS
The iFlash-Total PSA assay is a paramagnetic particle Reagent kit, 100 tests, 2 packs, 50 tests/pack
chemiluminescent immunoassay (CLIA) for the Anti-PSA coated microparticles, 3.5
quantitative determination of total prostate specific antigen R1
mL/pack, 0.05% ProClin 300.
(TPSA) in human serum and plasma using the iFlash
Immunoassay Analyzer. Anti-PSA acridinium-labeled conjugate, 4.0
R2
mL/pack, 0.05% ProClin 300.
SUMMARY AND EXPLANATION
Calibrator 1, 1 bottle, 1.0 mL, Tris buffer
Prostate specific antigen (PSA) is a glycoprotein acting as CAL1
with protein stabilizers, 0.05% ProClin 300.
a serine protease. The proteolytic activity of PSA in blood
Calibrator 2, 1 bottle, 1.0 mL, PSA in Tris
is inhibited by the irreversible formation of complexes with
proteinase inhibitors such as alpha-1-antichymotrypsin, CAL2 buffer with protein stabilizers, 0.05%
alpha-2-macroglobulin and other acute phase proteins. In ProClin 300.
addition to being present in these complexes, PSA is also Calibrator 3, 1 bottle, 1.0 mL, PSA in Tris
present in blood in the free form, but is proteolytically CAL3 buffer with protein stabilizers, 0.05%
inactive. Elevated concentrations of PSA in serum are ProClin 300.
generally indicative of a pathologic condition of the
prostate (prostatitis, benign hyperplasia or carcinoma). MATERIALS REQUIRED (BUT NOT PROVIDED)
PSA testing has significant value in detecting metastatic or REF C89999/C89959/C89949, iFlash Pre-Trigger
persistent prostate diseases in patients following surgical Solution: hydrogen peroxide solution.
or medical treatment of prostate cancer. Persistent REF C89998/ C89958/ C89948, iFlash Trigger Solution:
elevation of PSA following treatment, or an increase in a sodium hydroxide solution.
post-treatment PSA level is indicative of recurrent or REF C89997, iFlash Wash Buffer: phosphate buffered
residual disease. PSA testing is widely accepted as an saline solution with 0.05% ProClin 300.
adjunctive test in the management of prostate cancer
REF C80001, iFlash Wash Buffer (10×): phosphate
patients.
buffered saline solution with 0.05% ProClin 300.
PSA tests lack sufficient sensitivity and specificity to be
REF C89996, reaction vessels.
considered ideal or absolutely diagnostic for screening or
early detection because PSA is not specific for prostate Controls: Commercial controls could be used.
cancer. A number of studies have found that the % Free WARNINGS AND PRECAUTIONS
PSA (FPSA) was significantly lower in patients having
IVD For in vitro diagnostic use
prostate cancer than those with benign disease or normal
controls. The ratio FPSA/TPSA has been demonstrated to  No known test method can offer the complete
improve the sensitivity and specificity in patients with assurance that products derived from human sources
TPSA values in the “gray zone” of 4-10 ng/mL. will not transmit infection. Therefore, all human
sourced materials should be considered potentially
ASSAY PRINCIPLE infectious.
The iFlash-Total PSA assay is a sandwich immunoassay.  Exercise the normal precautions required for handling
 Incubation: Total PSA in the sample, anti-PSA coated all laboratory reagents.
paramagnetic microparticles and anti-PSA  Disposal of all waste material should be in accordance
acridinium-labeled conjugate react to form a sandwich with local guidelines.
complex.  Wear gloves when handling specimens or reagents.
 Wash: The unbound materials are washed away from  Clean and disinfect all spills of specimens or reagents
the solid phase in a magnetic field. using a suitable disinfectant.
 Trigger of signal: The Pre-Trigger and Trigger  iFlash Trigger solution contains sodium hydroxide
Solutions are added to the reaction mixture. The (NaOH) and should be avoided contact with eyes.
resulting chemiluminescent reaction is measured as
relative light units (RLUs). REAGENT HANDLING
 A direct relationship exists between the amount of total  The reagents may not be used after the stated
PSA in the sample and the RLUs detected by the expiration date.
iFlash optical system.  Avoid the formation of foam with all reagents.
 Results are determined via a calibration curve, which  The reagents in the pack and calibrators are ready for
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Total PSA iFlash
Immunoassay Analyzer

use .Close the bottles of calibrator right after ASSAY PROCEDURE

calibration and store at 2–8°C.  Refer to the system operating instruction or the online
 Do not pool reagents within a reagent kit or between help system for detailed information on preparing the
reagent kits. system.
 Prior to loading the iFlash-Total PSA reagent pack on the  The test-specific parameters stored in barcode on the
system for the first time, resuspend the microparticles by reagent pack are read in. In cases the barcode cannot
inverting the reagent pack 30 times slightly be read, enter the sequence numbers.
 For further information on reagent handling precautions  Carry out calibration, if necessary.
during system operation, refer to the iFlash system  Place the calibrators CAL1, CAL2, and CAL3 in the
operating instruction. calibrator rack in the sample zone. Only keep
calibrators open during calibration.
STORAGE AND STABILITY
 Test application.
Storage:
 Load samples.
 Store at 2–8°C in an upright position.
 Press RUN, the iFlash System performs all the
 The kit may be used immediately after removal from
functions automatically and calculates the results.
2-8°C storage.
 PSA in the sample concentration is lower than 17000
Stability:
ng/mL, there will be no HOOK effect.
 Unopened at 2–8°C: up to the stated expiration date.
 Opened at 2–8°C: 28 days. CALIBRATION
 Store on-board: 28 days.  Traceability: This assay has been standardized
against the Stanford Reference Standard/WHO 96/670
SPECIMEN COLLECTION AND PREPARATION (90 % PSA-ACT + 10 % Free PSA).
 Serum or plasma (lithium heparin, sodium heparin  Every iFlash-Total PSA reagent kit has a QR code
potassium EDTA, and sodium citrate) are the label containing the specific information for calibration
recommended samples. Other anticoagulants have not of the particular reagent lot.
been validated for use with the iFlash-Total PSA assay.  To perform an iFlash-Total PSA calibration, test CAL1.
 Ensure that serum specimens to form complete clot CAL2, and CAL3 in duplicate, and the predefined
prior to centrifugation. master curve is adapted to the analyzer.
 Centrifuge the specimens.  Once an iFlash-Total PSA calibration is accepted and
 Store specimens at room temperature (20 to 25°C) for stored, all subsequent samples may be tested without
no longer than 8 hours. further calibration unless:
 If the testing will not be completed within 8 hours,  After 28 days when using the same reagent lot.
refrigerate the samples at 2 to 8°C.  A reagent kit with a new lot number is used
 If the testing will not be completed within 3 days, or for  Controls are out of range
shipment of samples, freeze at -20°C or colder.  Required by pertinent regulations.
 Frozen specimens must be mixed thoroughly after
thawing. MEASURING RANGE
 The samples may be frozen for maximum 1 time.  0.01 – 100 ng/mL
 Centrifuged specimens with a lipid layer on the top, and QUALITY CONTROL
transfer only the clarified specimen without the lipemic
Quality control materials should be run as single
material.
determinations at least once every 24 hours when the test
 Ensure that residual fibrin and cellular matter have is in use, once per reagent kit and after every calibration.
been removed prior to analysis. Include commercially available quality control materials
 Use caution in handling patient specimens to prevent that cover at least two levels of analyte. Follow
cross-contamination. manufacturer’s instructions for reconstitution and storage.
 Do not use heat-inactivated samples. Each laboratory should establish mean values and
acceptable ranges to assure proper performance. Quality
 Ensure the patient samples, calibrators and controls
control results that do not fall within acceptable ranges
are at ambient temperature (20–25°C) before
may indicate invalid test results.
measurement.
 Due to the possible evaporation, specimens and RESULT
calibrators on the analyzers should be measured within Calculation:
2 hours.
The iFlash system automatically calculates the analyte
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Total PSA iFlash
Immunoassay Analyzer

concentration of each sample. The results are given in total PSA were assayed.
ng/mL. The within run precision was determined by testing each
sample in replicates of 10 (n = 10), and calculating percent
Expected Values:
coefficient of variation (%CV). The results of the study are
A study of iFlash Total PSA assay on samples from 281 shown below:
apparently healthy males of various age groups yielded the Sample Mean (ng/mL) SD %CV
following result:
1 4.36 0.17 3.90
th
< 4 ng/mL (95 percentile) 2 30.26 1.68 5.55
It is recommended that each laboratory establish its own
The between run precision was determined by testing
expected reference range for the population of interest.
each sample in duplicate, two separate runs daily for 20
LIMITATIONS days (n = 80), and calculating percent coefficient of
 The iFlash-Total PSA assay is limited to the variation (%CV). The results of the study are shown
determination of total PSA in human serum or plasma below:
Sample Mean (ng/mL) SD %CV
(lithium heparin, sodium heparin, potassium EDTA, and
sodium citrate). It has not been validated for use with 1 4.41 0.18 4.08
other types of plasma. 2 30.05 1.43 4.76
 The use of serum separator (gel) blood collection tubes
Analytical Sensitivity
has been validated for use with this assay; however it is
not possible to survey all manufacturers or tube types. The detection limit representing the lowest measurable
analyte level that can be distinguished from zero is 0.01
 The upper limit of the measuring range of this assay is
ng/mL. It is calculated as the value lying two standard
100 ng/mL. Over-range samples may be diluted with
deviations above that of the lowest standard of the master
negative human serum and re-tested to obtain an
curve (standard 1 + 2 SD, n = 20).
estimate of the actual concentration.
 If the results are inconsistent with clinical evidence, Method comparison
additional testing is suggested to confirm the result. A comparison of the iFlash-Total PSA assay (y) with a
 For diagnostic purposes, the results should be commercially available total PSA assay (x) using clinical
interpreted in light of the total clinical presentation of the samples was performed, and the curve is fitted with Linear
patient, including symptoms, clinical history results. regression)
 Specimens from heparinized patients may be partially y = 0.9938x -0.1092
coagulated and erroneous results could occur due to r = 0.998
the presence of fibrin.
Sample concentration: 0.23 – 99 ng/mL
 The results from an alternative assays (i.e. EIA or RIA)
Number of samples measured: 90
may not be equivalent and cannot be used
interchangeably. Equimolar reactivity
 Samples containing an apparent total PSA level as high On different proportions of PSA-ACT and free PSA, the
as 17000 ng/mL did not exhibit a hook effect in the deviations of total PSA should not exceed±15%.
iFlash Total PSA assay.
Accuracy
 The assay is unaffected by icterus (bilirubin < 30
mg/dL), hemolysis (Hb < 1500 mg/dL), lipemia The relative deviations.≤10%.
(Intralipid < 1500 mg/dL) and total serum protein (< 10 Range of linear
g/dL).
In the range of 0.01-80 ng/mL, the correlation coefficient
 No interference was observed from rheumatoid factors ＞0.99.
up to a concentration of 2000 IU/mL.
 No interference was observed from anti-nuclear REFERENCES
antibodies up to a concentration of 500 U/mL. 1. Tewari PC, Bluestein BI. Multiple forms of prostate
 No interference was observed from HAMA up to a specific antigen and the influences of immunoassay
concentration of 600 ng/mL. design on their measurement in patient serum. J Clin
Ligand Assay, 18 1995;3:186-196.
PERFORMANCE CHARACTERISTICS 2. Prestigiacomo AF, Stamey TA. Clinical usefulness of
Below are the representative performance data, and the free and complexed PSA. Clin Lab Invest Suppl
results obtained in individual laboratories may differ. 1995;221:32-34.

Precision 3. Semjonow A, De Angelis G, Oberpenning F et al. The

clinical impact of different assays for prostate specific
Two controls, consisting low, and median concentration of
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Total PSA iFlash
Immunoassay Analyzer

antigen. BJU Int. 2000; 86(5):590-7 ANNEX A:

4. Kuriyama M, Wang MC, Papsidero LD, et al. Explanation of abbreviation
Quantitation of Prostate-Specific Antigen in Serum by
Abbreviation Explanation
a Sensitive Enzyme Immunoassay. Cancer Res
1980;40:4658-62.
5. Oesterling JE. Prostate Specific Antigen: A Critical Product No.
Assessment of the Most Useful Tumor Marker for
Adenocarcinoma of the Prostate. J Urol Calibrator
1991;145:907-23.
6. Kantoff PW, Talcott JA. The Prostate Specific Antigen. Reagent
Its Use as a Tumor Marker for Prostate Cancer
Hematol Oncol Clin N Amer 1994;8:555-72.
Number of tests
7. Partin AW, Oesterling JE. The Clinical Usefulness of
Prostate Specific Antigen: Update 1994. J Urol
1994;152:1358-68. Manufactured by
8. Bunting S. A Guide to the Interpretation of Serum
Prostate Specific Antigen Levels. Clin Biochem EU Representative
1995;28:221-41.
9. Catalona WJ, Richie JP, Ahmann FR, Hudson MA, EC Declaration of Conformity
Scardino PT, Flanigan RC, et al. Comparison of digital
rectal examination and serum prostate-specific antigen
in the early detection of prostate cancer: results of Caution
a multicenter clinical trial of 6,630 men. J Urology
1994;151(5):1283-1290. Instructions for use
10. Chen YT, Luderer AA, Thiel RP, et al. Using
proportions of free to total prostate-specific antigen, In vitro diagnostic medical
age, and total prostate-specific antigen to predict the device
probability of prostate cancer. Urology
Lot No.
1996;47:518-524.
11. Thiel RP, Oesterling JE, Wojno KJ, et al. A multicenter
comparison of the diagnostic performance of free Date of manufacture
prostate-specific antigen. Urology 1996;48(6A):45-50.
Expiry date

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