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December 2000


Procedure:  Nitrazine paper
Product: Apothecon Nitrazine paper
State:  
Accrediting organization: 
NCCLS format:Yes

<GOOD HEALTH HOSPITAL>
CLINICAL LABORATORY PROCEDURE MANUAL

Subject: NITRAZINE

Effective Date: 5/29/99

Category:

Supersedes: 8/11/97

Distributed to: L&D

Prepared:

Reviewed:

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PURPOSE

Nitrazine (Phenaphthazine ) paper is used to measure the vaginal pH of expectant mothers.

PRINCIPLE

Nitrazine paper is impregnated with an indicator dye Phenaphthazine. The color changes as pH changes, giving a broad range of colors from yellow through blue.

SUPPLIES

Phenaphthazine reagent strip.

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STORAGE

Store Phenaphthazine reagent strips at room temperature.

PATIENT PREPARATION

No patient preparation other than that required by a written protocol.

PROCEDURE

Standard Precautions must be adhered to by testing personnel.

Obtain a strip of Nitrazine paper approximately three inches long from the dispenser.

Wrap the paper around the ends of the fingers of one hand.

Insert the fingers and paper into the birth canal.

Remove the paper and excess fluid.

Compare the resulting color to the paper dispenserís pH scale.

Record results on the patient chart.

Reports results as:

6.5 -6.5 =positive.
6.0 and below = negative.

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Criteria for Unacceptable Specimens:

The specimen is estimated to be stable for 2-5 minutes at room. Contamination with blood will interfere with the reading. Bloody specimens should be read with caution, as it is difficult to interpret the color reaction.

EXPECTED VALUES

Normal vaginal pH is acidic (below 7.0). pH results above 7.0 ( basic) indicate that amniotic fluid is present. Bring results to the attention of the attending physician.

QUALITY CONTROL

Supplies:

pH calibrating buffers; pH 6.0 and pH 8.0 Store buffers at room temperature. Buffers are stable until the expiration date on the bottles.

Policy:

Both controls are run once each day of use.

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Procedure:

1. Add one drop of buffer to Nitrazine test paper.

2. Compare color to the paper dispenser's pH scale. The pH must be within 0.5 of the designated pH to be acceptable.

3. Document all results on the Control Sheet. If controls are out of range do not report any patient results until corrective action has been taken:

Repeat the procedure

Repeat using a different Nitrazine test packet

If controls are still out of range, call the Laboratory for assistance

SPECIFIC PERFORMANCE CHARACTERISTICS

The Nitrazine paper measures pH values generally to within 1 pH unit in the range of 4.5-7.5 visually.

REFERENCES

Apothecon, Princeton, NJ, Nitrazine Paper, p0083-00, p0084-00 52520.
Communication from Bristol-Myers Squibb Company, March 28,1997.
Hellman, L.M., et. al., Williams Obstetrics. 14
th edition, New York, Appleton-Century-Crofts; 1971, p 405-406.

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