Gima PSA PROSTATA TEST User guide

PSA Rapid Test Cassette

REF TPS-402

English

 Test cassettes

 Droppers

 Buffer

 Package insert

 Specimen collection containers

 Centrifuge

 Lancets (for fingerstick whole blood only)

 Timer

 Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)

Attention, see

instructions for use

Tests per kit

Authorized

Representative

For in vitro

diagnostic use only

Use by

Do not reuse

Store between 2-30°C

Lot Number

Catalog #

Do not use if package is

damaged

Manufacturer

Consult Instructions

For Use

Number:

145022305

Effective date:

2018-06-13

Method

ELISA

Total Results

PSA Rapid

Test Cassette

Results

Positive

Negative

Positive

205 3 208

Negative 2 351

353

Total Results

207

354

561

0123

(Whole Blood /Serum/Plasma)

Package Insert

A rapid test for the Semi-Quantitative detection of Prostate Specific Antigen (PSA) in whole
blood, serum or plasma.
For professional in vitro diagnostic use only.

【INTENDED USE】

The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Cassette (Whole Blood
/Serum /Plasma) is a rapid chromatographic immunoassay for semi-quantitative detection of
Prostate Specific Antigen in whole blood, serum or plasma.

【SUMMARY】

Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It is a
single chain glycoprotein with a molecular weight of approximate 34 kDa.1 PSA exists in three
major forms circulating in the serum. These forms are free PSA, PSA bound to α1 –
Antichymotrypsin (PSA-ACT) and PSA complexed with α2–macroglobulin (PSA-MG).2
PSA has been detected in various tissues of the male urogenital system but only prostate
glandular and endothelial cells secrete it. The PSA level in serum of healthy men is between

0.1 ng/mL and 2.6 ng/mL. It can be elevated in malignant conditions such as prostate cancer,
and in benign condition such as benign prostatic hyperplasia and prostatitis. A PSA level of 3
to 10ng/ml is considered to be in the “gray-zone” and levels above 10ng/ml are highly
indicative of cancer.3 Patients with PSA values between 3-10ng/ml should undergo further
analysis of the prostate by biopsy.
The prostate specific antigen test is the most valuable tool available for the diagnosis of early
prostate cancer. Many studies have confirmed that the presence of PSA is the most useful and
meaningful tumor marker known for prostate cancer and prostate infection of Benign Prostatic
Hyperplasia (BPH).4
The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Cassette (Whole blood
/Serum /Plasma) utilizes a combination of colloidal gold conjugate and anti-PSA antibodies to
selectively detect total PSA in whole blood, serum or plasma. The test has a cut-off value of
3ng/ml and a reference value of 10ng/ml.

【PRINCIPLE】

The PSA Rapid Test Cassette (Whole Blood /Serum /Plasma) is a semi-quantitative,
membrane based immunoassay for the detection of PSA in whole blood, serum or plasma.
The membrane is pre-coated with PSA antibodies on the test line region. During testing, the
specimen reacts with the particle coated with anti-PSA antibody. The mixture migrates upward
on the membrane chromatographically by capillary action to react with anti-PSA antibodies on
the membrane and generate a colored line. A test line (T) intensity weaker than the reference
line (R) indicates that the PSA level in the specimen is between 3-10ng/ml. A test line (T)
intensity equal or close to the reference line (R) indicates that the PSA level in the specimen is
approximately 10ng/ml. A test line (T) intensity stronger than the reference line (R) indicates
that the PSA level in the specimen is above 10ng/ml. To serve as a procedural control, a
colored line will always appear in the control line region (C) indicating that proper volume of
specimen has been added and membrane wicking has occurred.

【REAGENTS】

The cassette contains PSA monoclonal antibody particles and PSA monoclonal antibody
coated on the membrane.

【PRECAUTIONS】
Please read all the information in this package insert before performing the test.

1. For professional in vitro diagnostic use only. Do not use after the expiration date.

2. The test should remain in the sealed pouch until ready to use.

3. Do not eat, drink or smoke in the area where the specimens or kits are handled.

4. Do not use the test if the pouch is damaged.

5. All specimens should be considered potentially hazardous and handled in the same manner
as an infectious agent.

6. Wear protective clothing such as laboratory coats, disposable gloves or eye protection
when specimens are being tested.

7. The used test should be discarded according to local regulations.

8. Humidity and temperature can adversely affect results.

【STORAGE AND STABILITY】

Store as packaged at room temperature or refrigerated (2-30°C). The test is stable through the
expiration date printed on the sealed pouch. The test must remain in the sealed pouch until
use. DO NOT FREEZE. Do not use beyond the expiration date.

【SPECIMEN COLLECTION AND PREPARATION】

 The PSA Rapid Test Cassette (Whole blood /Serum /Plasma) can be performed using

whole blood (from venipuncture or fingerstick) serum or plasma.

 To collect Fingerstick Whole Blood specimens:

 Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow

to dry.

 Massage the hand without touching the puncture site by rubbing down the hand towards

the fingertip of the middle or ring finger.

 Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
 Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the

puncture site.

 Add the Fingerstick Whole Blood specimen to the test by using a capillary tube:

 Touch the end of the capillary tube to the blood until filled to approximately 80 L.

Avoid air bubbles.

 Place the bulb onto the top end of the capillary tube, then squeeze the bulb to

dispense the whole blood to the specimen well (S) of the test cassette.

 Add the Fingerstick Whole Blood specimen to the test by using hanging drops:

 Position the patient’s finger so that the drop of blood is just above the specimen well

(S) of the test cassette.

 Allow 2 hanging drops of fingerstick whole blood to fall into the center of the specimen

well (S) on the test cassette, or move the patient’s finger so that the hanging drop
touches the center of the specimen well (S) Avoid touching the finger directly to the
specimen well (S).

 Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only

clear non-hemolyzed specimens.

 Testing should be performed immediately after the specimens have been collected. Do not

leave the specimens at room temperature for prolonged periods. Serum and plasma
specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens
should be kept below -20°C. Whole blood collected by venipuncture should be stored at
2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood
specimens. Whole blood collected by fingerstick should be tested immediately.

 The K2 EDTA anticoagulant tube, Sodium Citrate anticoagulant tube, Potassium Citrate

anticoagulant tube, Sodium Heparin anticoagulant tube, Lithium Heparin anticoagulant tube,
Sodium Oxalate anticoagulant tube could be used to collect the whole blood specimen.

 Bring specimens to room temperature prior to testing. Frozen specimens must be

completely thawed and mixed well prior to testing. Specimens should not be frozen and
thawed repeatedly.

 If specimens are to be shipped, they should be packed in compliance with local regulations

covering the transportation of etiologic agents.

【MATERIALS】

Materials required but not provided

【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C)

prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the
sealed pouch and use it as soon as possible.

2. Place the cassette on a clean and level surface.

For Serum，Plasma or Venipuncture Whole Blood specimens:

 Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately

40L) or 2 drops of venipuncture whole blood (approximately 80l) to the specimen

well (S) of test cassette, then add 1 drop of buffer (approximately 40L) and start the
timer. See illustration below.

For Fingerstick Whole Blood specimen:

 To use a capillary tube: Fill the capillary tube and transfer approximately 80L of

fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 1
drop of buffer (approximately 40 L) and start the timer. See illustration below.

 To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen

(approximately 80 L) to fall into the specimen well (S) of test cassette, then add 1 drop
of buffer (approximately 40 L) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear*. Read results at 5 minutes. Do not interpret the
result after 10 minutes.
*Note: if migration is not observed in the result window after 30 seconds, add one or two
extra drops of buffer.

Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

【INTERPRETATION OF RESULTS】

POSITIVE:* Three distinct colored lines appear.

 A test line (T) intensity weaker than the reference line (R) indicates a PSA level between

3-10 ng/ml.

 A test line (T) intensity equal or close to the reference line (R) indicates a PSA level of

approximately 10ng/ml.

 A test line (T) intensity stronger than the reference line (R) indicates a PSA level more

than 10ng/ml.

NEGATIVE: Color lines appear in both the control (C) and reference (R) regions.

colored line appears in the test line region (T). This indicates a PSA level below 3ng/ml.
INVALID: Control line (C) or reference line (R) fails to appear. Insufficient specimen
volume or incorrect procedural techniques are the most likely reasons for control line failure.
Review the procedure and repeat the test with a new test cassette. If the problem persists,
discontinue using the test kit immediately and contact your local distributor.

(Please refer to the illustration above)

Materials provided

No apparent

【QUALITY CONTROL】

A procedural control is included in the test. The appearance of colored lines in the control line
region (C) and reference line region (R) is considered a procedural control. It confirms
sufficient specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and
negative controls be tested as a good laboratory practice to confirm the test procedure and to
verify proper test performance.

【LIMITATIONS】

1. The PSA Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use
only. This test should be used for the detection of PSA in whole blood, serum or plasma
specimen.

2. The PSA Rapid Test Cassette (Whole blood /Serum /Plasma) will only indicate the semi
quantitative level of PSA in the specimen and should not be used as the sole criteria for the
diagnosis of Prostate Cancer.

3. A significant numbers of patients with BPH (more that 15%) and less than 1% of healthy
individuals have elevated PSA. Even if the test results are positive, further clinical
evaluation should be considered with other clinical information available to the physician.

4. PSA levels may be unreliable in patients who receive hormone therapy or prostate gland
manipulation.

5. High concentrations of PSA may produce a dose hook effect, resulting in false negative
results. High dose hook effect has not been observed with this test up to 30,000ng/ml PSA.

6. The hematocrit of the whole blood should be between 25% and 65%.

【EXPECTED VALUES】

The minimum indicative level of PSA for Prostate Cancer is generally agreed to be 3ng/ml and
the warning level is generally agreed to be 10ng/ml.3 The PSA Rapid Test Cassette (Whole
blood/Serum/Plasma) has been compared with a leading commercial PSA ELISA test. The
correlation between these two results is more than 99.0%.

【PERFORMANCE CHARACTERISTICS】

The PSA Rapid Test Cassette (Whole blood /Serum /Plasma) has been tested with a leading
commercial PSA ELISA Test using clinical samples.

Relative Sensitivity: 99.0% (95%CI:*96.6%-99.9%) *Confidence Intervals
Relative Specificity: 99.2% (95%CI:*97.5%-99.8%)
Overall accuracy: 99.1% (95%CI:*97.9%-99.7%)

Assays were carried out to determine assay reproducibility using replicates of 10 tests in three
different runs for each of three lots using PSA specimen levels at 0ng/ml, 2ng/ml, 3ng/ml,
10ng/ml and 20ng/ml. The specimens were correctly identified >99% of the time.

Between-run precision has been determined by using the five PSA specimen levels at 0ng/ml,
2 ng/ml, 3 ng/ml, 10 ng/ml and 20 ng/ml of PSA in 3 independent assays. Three different lots
of the PSA Rapid Test Cassette (Whole Blood /Serum /Plasma) have been tested using these
specimens. The specimens were correctly identified >99% of the time.

The following substances do not interfere with the test results at the indicated concentrations:
Ascorbic Acid at 200mg/l, Hemoglobin at 10g/l, Triglyceride at 30g/l, Bilirubin at 1,000mg/dl,
Uric Acid at 200mg/l.

【BIBLIOGRAPHY】

1. Wang MC, Valenzuela LA, Murphy GP, et al., Purification of human prostate specificity
antigen. Invest Urol 1979; 17: 159-163.

2. Christens A, Laurell CB, Lilja H. Enzymatic activity of prostate –specific antigen and its
reaction with extracellular serine proteinase Inhibitors. Eur J Biochem 1990; 194:755-763.

3. Catalona WJ, Southurick PC, Slawin KM, et al., Comparison of percent free PSA, PSA
density and age-specific PSA cut-offs for prostate cancer detection and staging. Urology
2000 Aug 1:56(2):255-60.

4. Vancangh PJ, De Nayer P, Sauvage P, et al., Free to total prostate-specific antigen (PSA)
ratio is superior to total PSA in differentially benign prostate hypertrophy from prostate
cancer. Prostate Supplement, 1996, 7:30-34.

Sensitivity and Specificity

Precision

Intra-Assay

Inter-Assay

Interfering Substances

Index of Symbols