One Step POCT Urine Pregnancy Test Instructions

One Step POCT Urine Pregnancy Test

Product Information

Specifications

• Product Name: One Step Pregnancy Test urine test strip
• Test Type: Rapid chromatographic immunoassay
• Target Analyte: hCG (human chorionic gonadotropin)
• Items Required: Test strip, specimen collection container, timer, OneStep Urine Pregnancy Testing Results Log

Product Usage Instructions

Reagents
The test strips contain colloidal gold coated with anti-hCG antibody, NC membrane coated with mouse anti-hCG antibody, and rabbit anti-mouse IgG.

Reagent Storage
Store the test strips in a cool, dry place. Do not freeze. Keep the strips sealed in the foil package until use.

Quality Control (QC)
A red line appearing in the Control region confirms the correct urine volume and procedure. Ensure the QC line is visible before conducting the test.

Specimen Collection:
Collect a urine sample in a clean container for testing.

Method

1. Dip the test strip into the urine sample for at least 15 seconds.
2. Do not let the urine level exceed the MAX line on the test strip.
3. Remove the strip from the urine and place it on a clean, dry surface.
4. Set a timer for 3 minutes.
5. Read the results on the strip after 3 minutes. Positive results may show before 3 minutes.

Frequently Asked Questions (FAQ)

• Q: Who should perform the urine pregnancy test?
  A: The test should only be performed by trained and competent staff as specified in the qualifications section of the manual.

• Q: How often should competencies be renewed?
  A: Competencies must be renewed every two years and signed by a link trainer.

RUH Bath NHS Foundation Trust – Pathology Department
STANDARD OPERATING PROCEDURE SOP/POCT/42/12 Title: Urine Pregnancy Test Effective date: 24/02/2024

COPY

Summary of Significant Changes at this Revision
Update to include new test instructions around dipping time and reading time. Plus additional interferences.

Purpose and Scope
The One Step Pregnancy Test urine test strip is a rapid chromatographic immunoassay for the qualitative detection of hCG in urine (urine pregnancy test).

Definitions and Abbreviations

• POCT = Point of care testing
• hCG = human chorionic gonadotropin
• QC = Quality Control
• EQA = External Quality Assurance
• QMS = Quality Management System

Items Required

1. One Step Pregnancy Test strip containing a combination of antibodies, including a monoclonal hCG antibody
2. Specimen collection container
3. Timer
4. OneStep Urine Pregnancy Testing Results Log -(see Appendix 1)

Grade / Qualifications Required
Nursing Staff – All trained operators
Health Care assistants – All trained operators
Medical Staff – All trained operators
Biomedical Scientists – All trained operators Supervised Trainee BMS staff

Competencies Required
Current Version of: FM/POCT/24 – POCT Competence/One Step HCG Urine Pregnancy Test Strip

Risk Assessment:
Current Version of: RA/POCT/20 Urine Pregnancy Testing – this can be found on the POCT intranet page

This test must ONLY be performed by trained and competent staff.
Competency sheets can be found on the intranet under:
Pathology > Point of Care Testing (POCT) > SOPs for POCT Users
Completed competencies must be signed by a link trainer and will require renewing every two years.

Reagents

Test strips are comprised of colloidal gold coated with anti β-hCG antibody; NC membrane coated with mouse anti α-hCG antibody and rabbit anti mouse IgG.
Test strips are supplied by the RUH pharmacy.

Reagent Storage

Store kit at 2 – 30oC
The test kits should be kept away from direct sunlight, moisture and heat.

Reagent Stability

• Test strip stable until the expiration date printed on sealed pouch.
• Test strip must remain sealed in foil package until use.
• Do not freeze.

Quality Control (QC)
A procedural QC is included in the test. A red line appearing in the Control region is the internal procedural QC. It confirms correct urine volume and correct procedure were used.

Specimen Collection

Urine must be collected into a clean dry container.
First morning urine preferred as it is most concentrated, but urine collected anytime of the day can be used. Please see Section 11 – Limitations.
Urine can be stored at 2 – 8oC up to 48 hours prior to testing. The specimen must be at room temperature before testing.
Urine specimen can be frozen and stored below -20oC. Ensure sample is thawed, at room temperature and mixed before testing.

Method

1. Ensure urine specimen and test strips are at room temperature (15 – 30oC).
2. Remove the test strip from the protective pouch and use the strip immediately.
3. Immerse the test strip tip vertically, with arrows pointing down, into the urine sample for at least 15 seconds.
4. DO NOT allow the urine level to go above the MAX (maximum) level line (marked by arrows) on the test strip.
5. Remove the strip from the urine and place the strip on a clean dry surface.
6. Set the timer for 3 minutes.
7. Read the strip at 3 minutes. N.B. Positive results may be apparent before 3 minutes have elapsed, but a negative result can only be confirmed after 3 minutes, when the background is clear.
8. Do not read the test strip after 10 minutes as the test will be invalid.
9. Discard the test strip and urine sample after testing – treat as biohazard waste.
10. N.B. If insufficient sample has been collected to carry out the test, then a repeat sample should be collected – and this must be recorded in the patient’s notes – and recorded as an incident in Datix if appropriate.
11. If unable to obtain a urine sample for analysis – a serum sample should be sent to the lab for hCG analysis

Interpretation and Reporting of Results

Positive Result
Two red lines will appear; one in the Control region and one in the Test region. Please refer to the diagrams on the test pouch for an illustration of a positive result.
A very faint line in the Test region must be taken as a positive result.

Negative Result
A red line on the Control region only indicates a negative test.

Invalid Result

1. The absence of any lines indicates the test has failed. Repeat using a new test strip.
2. A red line that appears in the Test region only, i.e. there is no control line, indicates the test has failed. Repeat using a new strip.
3. N.B. Stop using the test strips if the second test also fails.

Reporting Results
Test results should be written in two places:

1. Patient notes
2. Urine Pregnancy Testing Results Log (Appendix 1)

The following items must accompany the test result:

1. QC line observed
2. Test strip lot number
3. Test strip expiry date
4. Signature of person carrying out test and transcribing result

A patient results sticker (Appendix 2) can be filled in and stuck in the patient notes to assist with transcribing all the above information.

Sensitivity

The test strip will give a positive result if the hCG concentration in the urine is greater than 25 mIU/mL.

Accuracy
Comparison studies on the One Step HCG Urine Pregnancy Test with a legally marketed device were performed by the company and in a clinical reference laboratory. Positive and negative results were compared and the correlation was >99.5%

Interferences

Alcohol may interfere with the test result as well as hCG containing drugs (Pregnyl, Profasi, Pergonal, APL).

Limitations

1. The test strip should be read at exactly 3 minutes.
2. Alcohol consumption may interfere with the test result as well as hCG containing drugs (Pregnyl, Profasi, Pergonal, APL).
3. False negative results may occur if testing is done too early, (hCG levels may be below the sensitivity levels of the test) – repeat test 48 hours later with an early morning urine sample.
4. False negative results may occur if the urine specimen is very dilute (hCG levels are below the sensitivity levels of the test) – repeat test 48 hours later with an early morning urine sample.
5. Possible false positive results may be obtained several weeks post normal/caesarean delivery and post spontaneous/therapeutic abortion.
6. Very high levels (>500,000 mIU/ml) may give false negative results due to a ‘Prozone’ effect. If pregnancy is suspected, but the result is negative, a serum sample should be sent to the lab for hCG analysis.
7. Elevated levels of hCG are also seen in: trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumours, prostate cancer, breast cancer and lung cancer.

External Quality Assurance (EQA)

• EQA samples are distributed to all RUH departments enrolled in the Urine Pregnancy WEQAS EQA scheme (as per SOP/POCT/47 – Urine Pregnancy EQA)
• A set of 3 EQA samples is distributed every 2 months by POCT – along with a results return sheet
• The samples must be analysed as per the patient testing method described in this SOP
• The results should be entered on the return sheet and returned to POCT (B38) as soon as possible
• EQA performance is assessed retrospectively by WEQAS, as the results are not known at the time of distribution.
• The results are compared to those of other hospitals carrying out urine pregnancy testing, (using the same and different methods), and this gives an indication of the accuracy of the RUH performance.

C.O.S.H.H
Discard urine and all other test related materials as biohazard – as per the RUH Trust Policy: Policy & Procedure for the Management and Disposal of Waste

References

1. Package insert: – One Step Pregnancy Test, Hangzhou AllTest Biotech Co., Ltd., China.

(positive/negative)

| Quality Control line

present (Y/N)

| Test strip lot# & Expiry| User Name & Signature
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PREGNANCY TEST

• Time:
• Date:
• Patient:
• MRN:
• Consultant:
• Strip lot:
• Strip Expiry Date:

Test result:
NEGATIVE                                           Positive Quality control Line present: Signature:

……………………………………………………

| PREGNANCY TEST

• Time:
• Date:
• Patient:
• MRN:
• Consultant:
• Strip lot:
• Strip Expiry Date:

Test result: NEGATIVE          Positive Quality control Line present: Signature:

……………………………………………………

| PREGNANCY TEST

• Time:
• Date:
• Patient:
• MRN:
• Consultant:
• Strip lot:
• Strip Expiry Date:

Test result: NEGATIVE        Positive Quality control Line present: Signature:

……………………………………………………

---|---|---
PREGNANCY TEST

• Time:
• Date:
• Patient:
• MRN:
• Consultant:
• Strip lot:
• Strip Expiry Date:

Test result: NEGATIVE  Positive Quality control Line present: Signature:

……………………………………………………

| PREGNANCY TEST

• Time:
• Date:
• Patient:
• MRN:
• Consultant:
• Strip lot:
• Strip Expiry Date:

Test result: NEGATIVE  Positive Quality control Line present: Signature:

……………………………………………………

| PREGNANCY TEST

• Time:
• Date:
• Patient:
• MRN:
• Consultant:
• Strip lot:
• Strip Expiry Date:

Test result: NEGATIVE  Positive Quality control Line present: Signature:

……………………………………………………

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