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(5101)128-0032
June 5, 2001
Client No.
Ms. Denise Weiser
TMS Labs LABORATORIES, INC.
SUBJECT:
Private Label evaluation of OVULATION PREDICTOR KIT received on May 8, 2001.
INTRODUCTION:
The samples were compared to Clearplan Easy on the basis of appearance/construction, and performance.
| Sample Description: | CLEARPLAN EASY 1 STEP OVULATION PREDICTOR | OVULATION TEST MIDSTREAM | OVULATION PREDICTOR TEST |
| Contents/Count/Size: | Laboratory Packaging | Laboratory Packaging | Laboratory Packaging |
| Vendor: | Unipath Limited | TMS Labs | Inverness Medical |
| Lot No.: | CP046 | LH10202 | U25804A; U25506A |
| Expiration Date: | n/a | 02/02 | 5/02; 3/02 |
EXECUTIVE SUMMARY:
At the request of the client, packaging was not evaluated. It should be noted that the client provided the national brand product and the LH controls for this evaluation.
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| ACTS
Testing Labs, Inc. 100 Northpointe Parkway Buffalo, NY 14228-1884 USA Tel 716-505-3300 Fax 716-505-3301 www.actstesting.com |
This report is intended for your exclusive use Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our written permission. Our report is limited to the test samples identified herein the results set forth in this report are not necessarily indicative or representative of the statistical quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes all of the tests requested by you and the results thereof. You shall have thirty days from receipt of this report to request additional testing of the samples or to notify us of any errors or omissions relating to our report; provided, however. such notice shall be in writing and shall specifically address the issue you wish to raise. A failure to raise Such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. |
I) RESULTS:
TABLE I
OVULATION PREDICTOR KITS
| TEST/EVALUATION | CLEARPLAN EASY | TMS | INVERNESS |
| APPEARANCE/ CONSTRUCTION | Long, narrow test wand with removable cap covering absorbent tip and one window system for results | Long, narrow test wand with removable cap covering absorbent tip and one window system for results | Long, narrow test wand with removable cap covering absorbent tip and two window system for results |
| PERFORMANCE | |||
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- EASE OF USE | Simple, test wand held in urine stream for at least ten seconds | Simple, test wand held in urine stream for at least ten seconds | Simple, test wand held in urine stream for at least ten seconds |
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- EASE OF READABILITY | Positive result indicated by two lines of equal color and intensity in the control and test window, negative results indicated by a single line in the control window | Positive result indicated by two lines of equal color and intensity in the control and test window, negative results indicated by a single line in the control window | Positive result indicated by two lines of equal color and intensity in the control and test window, negative results indicated by a single line in the control window |
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- AVERAGE ELAPSED TIME TO ENDPOINT, MINUTES | 1 | 1 | 2 |
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-ACCURACY | Good* | Good* | Good* |
*Produced a positive result using the positive control solution and a negative result using the negative control solution.
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